Cervical DystoniaPhase 3NCT00407030
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
A Phase 3 study testing incobotulinumtoxinA (Xeomin) (240 Units) and incobotulinumtoxinA (Xeomin) (120 Units) in people with Cervical Dystonia, run by Merz Pharmaceuticals GmbH at 1 site in United States.
Trial summary
At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- incobotulinumtoxinA (Xeomin) (240 Units) and incobotulinumtoxinA (Xeomin) (120 Units)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2009
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Male or female outpatients between ages 18 and 75 years inclusive)
- A clinical diagnosis of cervical dystonia (i.e. spasmodic torticollis) with predominantly rotational form and a need for injection (determined by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score)
- TWSTRS-Total score >= 20
- TWSTRS-Severity score >= 10
- TWSTRS-Disability score >= 3
- TWSTRS-Pain score >= 1
- On a stable dose of medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period
- For pre-treated patients only: Source documentation of the last two consecutive injection sessions with Botulinum Toxin and stable therapeutic response directly prior to trial entry
- For pre-treated patients only: At least 10 weeks must have been passed between the last injection with Botulinum Toxin for cervical dystonia and baseline
- For pre-treated patients only: The most recent injection with Botulinum Toxin must have been maximal 300 Units of type A or 12,000 Units of type B
Main Exclusion Criteria:
- Traumatic torticollis or tardive torticollis
- TWSTRS-Severity score for anterocollis >= 2 points (pure anterocollis)
- TWSTRS-Severity score for retrocollis >= 2 points (pure retrocollis)
- Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation)
- Hypersensitivity to human serum albumin, sucrose, or Botulinum Toxin Type A
- Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
- Current swallowing disorder of any origin (dysphagia scale >= 3, i.e. severe, with swallowing difficulties and requiring a change in diet)
- Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spine syndrome
- Treatment with Botulinum Toxins for any indication other than cervical dystonia within 4 months prior to baseline and during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With a Double-blind Parallel-group Extension Period to Investigate the Efficacy and Safety of Different Doses of IncobotulinumtoxinA (Xeomin) in the Treatment of Cervical Dystonia
At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.
- Conditions
- Cervical Dystonia
- Being tested
- incobotulinumtoxinA (Xeomin) (240 Units), incobotulinumtoxinA (Xeomin) (120 Units), Placebo
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incobotulinumtoxinA (Xeomin) (240 Units)Drug
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units)
incobotulinumtoxinA (Xeomin) (120 Units)Drug
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 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 dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 240 units, total volume 4.8mL; Mode of administration: intramuscular injection Receives: Drug: incobotulinumtoxinA (Xeomin) (240 Units) |
| incobotulinumtoxinA (Xeomin) (120 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 dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 120 units, total volume 4.8 mL; Mode of administration: intramuscular injection Receives: Drug: incobotulinumtoxinA (Xeomin) (120 Units) |
| Placebo | Placebo comparator | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 4.8 mL; Mode of administration: intramuscular injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo
The TWSTRS-Total score is the sum of scores of the three components of the scale:
- TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
- TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
- TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Measured: Baseline, week 4
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo
The TWSTRS-Total score is the sum of scores of the three components of the scale:
- TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
- TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
- TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Measured: Baseline, week 4
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)
The TWSTRS-Total score is the sum of scores of the three components of the scale:
- TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
- TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
- TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Measured: Baseline, week 4
Secondary outcomes (5)
Change From Baseline in the TWSTRS-Total Score
The TWSTRS-Total score is the sum of scores of the three components of the scale:
- TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
- TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
- TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).
The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Measured: Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)
Change From Baseline in the TWSTRS Disability Subscore
TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Measured: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Change From Baseline in the TWSTRS Severity Subscore
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Measured: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Change From Baseline in the TWSTRS Pain Subscore
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Measured: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Patient Evaluation of Global Response (PEGR) at Final Visit
The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4).
Measured: Final visit (up to 20 weeks after injection of the Main Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2008
- Study completionJun 2009
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 (2)Papers the sponsor has linked to this study.
- Other trials for Cervical DystoniaStudies 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
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cynthia Comella, M.D., Study chair, Rush University Medical Center, 1725 West Harrison Street, Suite 755, Chicago, 60612 Illinois, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407030
- Sponsor's protocol ID
- MRZ 60201-0408
- Status last verified
- Jul 2013
- First submitted
- 30 Nov 2006
- Last updated
- 19 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; U.S. XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN(R), botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011 Sep 15;308(1-2):103-9. doi: 10.1016/j.jns.2011.05.041. Epub 2011 Jul 18.
PubMed 21764407Evidente VG, Fernandez HH, LeDoux MS, Brashear A, Grafe S, Hanschmann A, Comella CL. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in cervical dystonia. J Neural Transm (Vienna). 2013 Dec;120(12):1699-707. doi: 10.1007/s00702-013-1048-3. Epub 2013 Jun 19.
PubMed 23779062
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With a Double-blind Parallel-group Extension Period to Investigate the Efficacy and Safety of Different Doses of IncobotulinumtoxinA (Xeomin) in the Treatment of Cervical Dystonia
- ClinicalTrials.gov ID
- NCT00407030
- Acronym / sponsor ID
- MRZ 60201-0408
- Conditions
- Cervical Dystonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Posted 31 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Experimental | Drug: incobotulinumtoxinA (Xeomin) (240 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 dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 240 units, total volume 4.8mL; Mode of administration: intramuscular injection |
| incobotulinumtoxinA (Xeomin) (120 Units) | Experimental | Drug: incobotulinumtoxinA (Xeomin) (120 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 dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 120 units, total volume 4.8 mL; Mode of administration: intramuscular injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 4.8 mL; Mode of administration: intramuscular injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 (Xeomin) (240 Units)incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units) | Drug | incobotulinumtoxinA (Xeomin) (240 Units) |
| incobotulinumtoxinA (Xeomin) (120 Units)incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units) | Drug | incobotulinumtoxinA (Xeomin) (120 Units) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo
Time frame: Baseline, week 4
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo
Time frame: Baseline, week 4
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)
Time frame: Baseline, week 4
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
5 secondary outcomes
Change From Baseline in the TWSTRS-Total Score
Time frame: Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)
Change From Baseline in the TWSTRS Disability Subscore
Time frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Change From Baseline in the TWSTRS Severity Subscore
Time frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Change From Baseline in the TWSTRS Pain Subscore
Time frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Patient Evaluation of Global Response (PEGR) at Final Visit
Time frame: Final visit (up to 20 weeks after injection of the Main Period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21764407Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; U.S. XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN(R), botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011 Sep 15;308(1-2):103-9. doi: 10.1016/j.jns.2011.05.041. Epub 2011 Jul 18.
- Results publication: PubMed 23779062Evidente VG, Fernandez HH, LeDoux MS, Brashear A, Grafe S, Hanschmann A, Comella CL. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in cervical dystonia. J Neural Transm (Vienna). 2013 Dec;120(12):1699-707. doi: 10.1007/s00702-013-1048-3. Epub 2013 Jun 19.
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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.
Cynthia Comella, M.D. study chair
Rush University Medical Center, 1725 West Harrison Street, Suite 755, Chicago, 60612 Illinois, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing incobotulinumtoxinA (Xeomin) (240 Units) and incobotulinumtoxinA (Xeomin) (120 Units) in people with Cervical Dystonia, run by Merz Pharmaceuticals GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 31 Dec 2010). 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 the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo (time frame: Baseline, week 4). The study lists 3 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 NCT00407030, which also lists 2 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 19 Jul 2013.