Post-stroke Spasticity of the Upper LimbPhase 3PURENCT01392300
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
A Phase 3 study testing IncobotulinumtoxinA (400 Units) in people with Post-stroke Spasticity of the Upper Limb, run by Merz Pharmaceuticals GmbH at 47 sites in 7 countries.
Trial summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-stroke Spasticity of the Upper Limb
- What is being tested?
- IncobotulinumtoxinA (400 Units)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 47 sitesin 7 countries
- Study dates
- Sep 2011to Feb 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper limb spasticity
- Time since stroke greater than 3 months
- Need for 400 U Botulinum toxin type A
Who cannot join
- Body weight below 50kg
- Fixed contractures of the upper limb
- Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A
- Infection at the injection site
Trial locations and contacts
47 sites in 7 countries.
47 sites in 7 countries
United States13 sites
Merz Investigational Site #001037
Augusta, Georgia, 30912
Merz Investigational Site #001240
Chapel Hill, North Carolina, 27599
Merz Investigational Site #001245
Chattanooga, Tennessee, 37403
Merz Investigational Site #001186
Chicago, Illinois, 60611
Merz Investigational Site #001184
Downey, California, 90242
Merz Investigational Site #001017
Fountain Valley, California, 92728
Merz Investigational Site #001226
Houston, Texas, 77030
Merz Investigational Site #001188
Miami, Florida, 33172
Merz Investigational Site # 001110
Overland Park, Kansas, 66211
Merz Investigational Site #001241
Philadelphia, Pennsylvania, 19140
Merz Investigational Site #001211
Pittsburgh, Pennsylvania, 15213
Merz Investigational Site #001198
Stratford, New Jersey, 08084
Merz Investigational Site #001009
Winston-Salem, North Carolina, 27157
Poland10 sites
Merz Investigational Site # 048029
Gdansk, 80-254
Merz Investigational Site #048044
Kielce, 25-103
Merz Investigational Site #048031
Krakow, 31-505
Merz Investigational Site #048050
Lodz, 90-130
Merz Investigational Site #048051
Lublin, 20-022
Merz Investigational Site #048032
Olsztyn, 10-561
Merz Investigational Site #048053
Poznan, 61-485
Merz Investigational Site #048023
Warsaw, 02-957
Merz Investigational Site #048052
Warsaw, 04-141
Merz Investigational Site #048033
Warsaw, 04-749
Czechia8 sites
Merz Investigational Site #420046
Brno, 62500
Merz Investigational Site #420029
Brno, 65691
Merz Investigational Site #420028
Olomouc, 77520
Merz Investigational Site #420024
Ostrava-Poruba, 70852
Merz Investigational Site #420025
Pardubice, 53203
Merz Investigational Site #420030
Prague, 12000
Merz Investigational Site #420045
Prague, 15006
Merz Investigational Site #420047
Rychnov nad Kněžnou, 51601
India7 sites
Merz Investigational Site #091006
Bangalore, Karnataka, 560054
Merz Investigational Site #091007
Chennai, Tamil Nadu, 600116
Merz Investigational Site #091008
Coimbatore, Tamil Nadu, 641014
Merz Investigational Site #091001
Lucknow, Uttar Pradesh, 226003
Merz Investigational Site #091004
New Delhi, New Delhi, 110065
Merz Investigational Site #091003
Porur, Chennai, 600116
Merz Investigational Site #091002
Trivandrum, Kerala, 695011
Hungary4 sites
Merz Investigational Site #036004
Budapest, 1121
Merz Investigational Site # 036009
Budapest, 1204
Merz Investigational Site #036005
Nyíregyháza, 4400
Merz Investigational Site #036008
Szeged, 6725
Russia4 sites
Merz Investigational Site #007010
Krasnoyarsk, 660037
Merz Investigational Site #007011
Moscow, 105005
Merz Investigational Site #007009
Saint Petersburg, 129019
Merz Investigational Site #007005
Stavropol, 355000
About this study
Official title: Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.
Read the detailed description
The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).
- Conditions
- Post-stroke Spasticity of the Upper Limb
- Being tested
- IncobotulinumtoxinA (400 Units), Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinA (400 Units)Drug
Also called Xeomin
Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection
Placebo ComparatorDrug
Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| DB IncobotulinumtoxinA (Xeomin) (400 U) | Experimental | IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment Receives: Drug: IncobotulinumtoxinA (400 Units) |
| DB Placebo Comparator | Placebo comparator | Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 4
Investigator's Global Impression of Change
This is the co-primary outcome measure. The Global Impression of Change Scale [GICS] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.
Measured: Week 4
Secondary outcomes (48)
Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.
Measured: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-stroke Spasticity of the Upper LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392300
- Sponsor's protocol ID
- MRZ 60201/SP/3001
- Other IDs
- 2010-023043-15
- Acronym
- PURE
- Status last verified
- Nov 2016
- First submitted
- 7 Jul 2011
- Last updated
- 16 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Elovic EP, Munin MC, Kanovsky P, Hanschmann A, Hiersemenzel R, Marciniak C. Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity. Muscle Nerve. 2016 Mar;53(3):415-21. doi: 10.1002/mus.24776. Epub 2015 Dec 15.
PubMed 26201835Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life. PM R. 2020 May;12(5):491-499. doi: 10.1002/pmrj.12265. Epub 2020 Jan 22.
PubMed 31647185Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study. Adv Ther. 2019 Jan;36(1):187-199. doi: 10.1007/s12325-018-0833-7. Epub 2018 Nov 27.
PubMed 30484117
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb
- ClinicalTrials.gov ID
- NCT01392300
- Acronym / sponsor ID
- PURE / MRZ 60201/SP/3001
- Conditions
- Post-stroke Spasticity of the Upper Limb
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Posted 11 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.
Detailed description
The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DB IncobotulinumtoxinA (Xeomin) (400 U) | Experimental | Drug: IncobotulinumtoxinA (400 Units)IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment |
| DB Placebo Comparator | Placebo comparator | Drug: Placebo ComparatorPlacebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Upper limb spasticity
- Time since stroke greater than 3 months
- Need for 400 U Botulinum toxin type A
Key exclusion criteria (4 listed)
- Body weight below 50kg
- Fixed contractures of the upper limb
- Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A
- Infection at the injection site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncobotulinumtoxinA (400 Units)Also: XeominMain period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection | Drug | DB IncobotulinumtoxinA (Xeomin) (400 U) |
| Placebo ComparatorMain period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection | Drug | DB Placebo Comparator |
Primary outcome
Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
Time frame: Week 4
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Investigator's Global Impression of Change
Time frame: Week 4
This is the co-primary outcome measure. The Global Impression of Change Scale [GICS] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.
48 secondary outcomes
Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm
Time frame: Week 12
Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm
Time frame: Week 4
Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm
Time frame: Week 8
Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.
Time frame: Week 12
Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
Time frame: Week 4
Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
Time frame: Week 8
Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.
Time frame: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain
Time frame: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain
Time frame: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain
Time frame: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene
Time frame: Week 4
Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene
Time frame: Week 8
Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene
Time frame: Week 12
Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26201835Elovic EP, Munin MC, Kanovsky P, Hanschmann A, Hiersemenzel R, Marciniak C. Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity. Muscle Nerve. 2016 Mar;53(3):415-21. doi: 10.1002/mus.24776. Epub 2015 Dec 15.
- Derived from this study: PubMed 31647185Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life. PM R. 2020 May;12(5):491-499. doi: 10.1002/pmrj.12265. Epub 2020 Jan 22.
- Derived from this study: PubMed 30484117Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study. Adv Ther. 2019 Jan;36(1):187-199. doi: 10.1007/s12325-018-0833-7. Epub 2018 Nov 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
Merz Pharmaceuticals GmbH
47 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IncobotulinumtoxinA (400 Units) in people with Post-stroke Spasticity of the Upper Limb, run by Merz Pharmaceuticals GmbH at 47 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Poland, Czechia, India, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01392300, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.