Post-stroke Spasticity of the Lower LimbPhase 3PLUSNCT01464307
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
A Phase 3 study testing IncobotulinumtoxinA (400 Units) in people with Post-stroke Spasticity of the Lower Limb, run by Merz Pharmaceuticals GmbH at 53 sites in 9 countries.
Trial summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a 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 Lower 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
- 290 participants
- Where
- 53 sitesin 9 countries
- Study dates
- Dec 2011to May 2015
- 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
- Age from 18-80 yrs
- Lower 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 lower 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
53 sites in 9 countries.
53 sites in 9 countries
Poland13 sites
Merz Investigational Site #048057
Gdansk, 80-462
Merz Investigational Site #048044
Kielce, 25-103
Merz Investigational Site #048080
Krakow, 30-349
Merz Investigational Site #048054
Krakow, 30-510
Merz Investigational Site #048031
Krakow, 31-505
Merz Investigational Site #048022
Lodz, 90-130
Merz Investigational Site #048051
Lublin, 20-022
Merz Investigational Site #048053
Poznan, 61-485
Merz Investigational Site #048081
Poznan, 61-853
Merz Investigational Site #048055
Warsaw, 01-697
Merz Investigational Site #048023
Warsaw, 02-957
Merz Investigational Site #048056
Warsaw, 02097
Merz Investigational Site #048033
Warsaw, 04-749
United States12 sites
Merz Investigational Site #001209
Columbia, Missouri, 65212
Investigational site #001188
Doral, Florida, 33172
Merz Investigational Site #001184
Downey, California, 90242
Merz Investigational Site #001244
Fairfield, Connecticut, 06824
Merz Investigational Site #001183
Houston, Texas, 77030
Merz Investigational Site #001208
Long Beach, California, 90806
Merz Investigational Site #001206
Nashville, Tennessee, 37232
Merz Investigational Site # 001110
Overland Park, Kansas, 66211
Merz Investigational Site #001207
Plainview, New York, 11803
Merz Investigational Site #001210
St Louis, Missouri, 63110
Merz Investigational Site #001198
Stratford, New Jersey, 08084
Merz Investigational Site #001009
Winston-Salem, North Carolina, 27157
Germany8 sites
Merz Investigational Site #049022
Beelitz-Heilstätten, 14547
Merz Investigational Site #049071
Düsseldorf, 40225
Merz Investigational Site #049079
Hamburg, 20246
Merz Investigational Site #049304
Kiel, 24105
Merz Investigational Site #049072
München, 80804
Merz Investigational Site #049148
München, 81675
Merz Investigational Site #049303
Regensburg, 93053
Merz Investigational Site #049302
Würzburg, 97080
Spain5 sites
Merz Investigational Site #034027
Madrid, 28040
Merz Investigational Site #034028
Majadahonda, 28222
Merz Investigational Site #034026
Seville, 41009
Merz Investigational Site #034030
Seville, 41013
Merz Investigational Site #034029
Terrassa, 08221
Czechia4 sites
Merz Investigational Site #420024
Ostrava-Poruba, 70852
Merz Investigational Site #420031
Ostrava-Vitkovice, 70384
Merz Investigational Site #420030
Prague, 12000
Merz Investigational Site #420047
Rychnov nad Kněžnou, 51601
Russia4 sites
Merz Investigational Site #007010
Krasnoyarsk, 660037
Merz Investigational Site #007011
Moscow, 105005
Merz Investigational Site #007009
Saint Petersburg, 129019
Merz Investigational Site #007012
Stavropol, 355000
Italy3 sites
Merz Investigational Site #039006
Messina, 98125
Merz Investigational Site #039011
Roma, 00168
Merz Investigational Site #039012
Roma, 00189
Canada2 sites
Merz Investigational Site #001204
Halifax, Nova Scotia, B3H 4K4
Merz Investigational Site #001202
Winnipeg, MB R3A 1M4
France2 sites
Merz Investigational Site #033018
Garches, 92380
Merz Investigational Site #033024
Rennes, 35043
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 Lower Limb
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
- Conditions
- Post-stroke Spasticity of the Lower 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
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 |
|---|---|---|
| IncobotulinumtoxinA (Xeomin) 400 Units | Experimental | IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. Receives: Drug: IncobotulinumtoxinA (400 Units) |
| Placebo Comparator Arm | Placebo comparator | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. 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) for Plantar Flexors at Week 4
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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: Baseline and Week 4
Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12
A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.
Measured: Baseline to Week 12
Secondary outcomes (2)
Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)
Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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, 8, and 12
Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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). Here, 'n' specifies those subjects who were evaluated for this outcome measure at given time point.
Measured: Baseline, Week 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2014
- Study completionMay 2015
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.
- Other trials for Post-stroke Spasticity of the Lower 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 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
- NCT01464307
- Sponsor's protocol ID
- MRZ 60201/SP/3002
- Other IDs
- 2010-024579-23
- Acronym
- PLUS
- Status last verified
- Sep 2016
- First submitted
- 1 Nov 2011
- Last updated
- 7 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. 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 Lower Limb
- ClinicalTrials.gov ID
- NCT01464307
- Acronym / sponsor ID
- PLUS / MRZ 60201/SP/3002
- Conditions
- Post-stroke Spasticity of the Lower Limb
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Posted 7 Nov 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 leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IncobotulinumtoxinA (Xeomin) 400 Units | Experimental | Drug: IncobotulinumtoxinA (400 Units)IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. |
| Placebo Comparator Arm | Placebo comparator | Drug: Placebo ComparatorPlacebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18-80 yrs
- Lower 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 lower 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)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. | Drug | IncobotulinumtoxinA (Xeomin) 400 Units |
| 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 | Placebo Comparator Arm |
Primary outcome
Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4
Time frame: Baseline and Week 4
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the 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).
Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12
Time frame: Baseline to Week 12
A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.
2 secondary outcomes
Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)
Time frame: Week 4, 8, and 12
Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits
Time frame: Baseline, Week 4, 8, and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post-stroke Spasticity of the Lower Limb
Not yet recruiting
Extracorporeal Shock Wave Therapy in Botulinum Toxin-Treated Patients With Post-Stroke Ankle Plantar Flexor Spasticity
Stroke, Post-stroke Spasticity of the Lower Limb
RecruitingPhase 2/3
Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
Stroke
Recruiting
Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke
Stroke, Equinovarus Foot
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
53 sites in 9 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 Lower Limb, run by Merz Pharmaceuticals GmbH at 53 sites in 9 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 4 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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Poland, United States, Germany, Spain, Czechia and 4 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 7 Nov 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) for Plantar Flexors at Week 4 (time frame: Baseline and 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?
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 7 Nov 2016.