Cervical DystoniaPhase 4NCT00541905
Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia
A Phase 4 study testing NT 201 in people with Cervical Dystonia, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
Trial summary
The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions. 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?
- NT 201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - total score at baseline > / = 25 with TWSTRS - severity score > / = 10 and TWSTRS - disability score > / = 3
- Patients must be on a stable dose of other medications
- For pre-treated patients only: Source documentation of the last two consecutive injection sessions with botulinum neurotoxin type A and stable treatment response directly prior to trial entry
- For pre-treated patients only: At least 10 weeks must have passed between the last injection session of botulinum neurotoxin type A for cervical dystonia and the time of the baseline visit.
- For pre-treated patients only: The most recent injection session with botulinum neurotoxin for cervical dystonia must have been at a dose of ≤ 300 units of Botox® or Xeomin®, or ≤ 1,200 units Dysport®.
- Age > / = 18 and < 76 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single-arm, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 and the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Patients With Cervical Dystonia
The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions.
- Conditions
- Cervical Dystonia
- Being tested
- NT 201
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT 201Drug
Subjects to receive up to 5 injection sessions, with a total dose of up to 300 Units each. No more than 50 units should have be given at any one injection site during one session.
| Study group | Role | What they receive |
|---|---|---|
| NT 201 (50-300 Units) | Experimental | NT 201 (Xeomin®, also know as IncobotulinumtoxinA 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: NT 201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4
Measured: From baseline to week 4
Secondary outcomes (8)
TWSTRS, Single interventional effect
Single interventional effect of one injection session by the change of the TWSTRS total, severity and disability scores from each cycle baseline to 4 weeks thereafter.
Measured: From week 10-24 to week 14-28, from week 20-48 to week 24-52, from week 30-72 to week 34-76, and from week 40-96 to week 44-100
TWSTRS, overall interventional effect
Measured by the change in the TWSTRS total, severity and disability scores, from study baseline to each examination 4 weeks after the injection sessions
Measured: From study baseline to week 14-28, 24-52, 34-76, and 44-100
Global Assessment of Efficacy by Investigator (GAEI)
At the end of each injection cycle
Measured: Week 10-24, 20-48, 30-72, and 40-96
Subject Evaluation of Global Response (PEGR)
At the end of each injection cycle.
Measured: Week 10-24, 20-48, 30-72, and 40-96
Time from last injection session to onset of treatment effect as given by subjective subject assessment
Measured in days.
Measured: Up to 4 weeks from last injection session
Time from last injection session to waning of treatment effect as rated by subjective subject assessment
Measured in weeks.
Measured: Up to 24 weeks from last injection session
Duration of treatment effect
Defined as time period within an injection cycle from the day of the injection session until the day where the need for reinjection was indicated by the subject (if subject experienced an onset of treatment effect).
Measured: Up to 24 weeks from last injection session
Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline
Measured: From study baseline up to week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dirk Dressler, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541905
- Sponsor's protocol ID
- MRZ 60201-0605/1
- Other IDs
- 2006-003410-18
- Status last verified
- Jun 2013
- First submitted
- 8 Oct 2007
- Last updated
- 4 Jun 2013
- Results posted
- No
Publications
Dressler D, Kupsch A, Paus S, Seitzinger A, Gebhardt B. Sustained efficacy of Incobotulinumtoxin-A (Xeomin®; Botulinum Neurotoxin Type-A, free from Complexing Proteins) in Long-Term Treatment of Cervical Dystonia. European Journal of Neurology 18 (Suppl. 2): 482, 2011.
Dressler D, Paus S, Seitzinger A, Gebhardt B, Kupsch A. Long-term efficacy and safety of incobotulinumtoxinA injections in patients with cervical dystonia. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1014-9. doi: 10.1136/jnnp-2012-303608. Epub 2013 May 18.
PubMed 23687362
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 and the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Patients With Cervical Dystonia
- ClinicalTrials.gov ID
- NCT00541905
- Acronym / sponsor ID
- MRZ 60201-0605/1
- Conditions
- Cervical Dystonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NT 201 (50-300 Units) | Experimental | Drug: NT 201NT 201 (Xeomin®, also know as IncobotulinumtoxinA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - total score at baseline > / = 25 with TWSTRS - severity score > / = 10 and TWSTRS - disability score > / = 3
- Patients must be on a stable dose of other medications
- For pre-treated patients only: Source documentation of the last two consecutive injection sessions with botulinum neurotoxin type A and stable treatment response directly prior to trial entry
- For pre-treated patients only: At least 10 weeks must have passed between the last injection session of botulinum neurotoxin type A for cervical dystonia and the time of the baseline visit.
- For pre-treated patients only: The most recent injection session with botulinum neurotoxin for cervical dystonia must have been at a dose of ≤ 300 units of Botox® or Xeomin®, or ≤ 1,200 units Dysport®.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NT 201Subjects to receive up to 5 injection sessions, with a total dose of up to 300 Units each. No more than 50 units should have be given at any one injection site during one session. | Drug | NT 201 (50-300 Units) |
Primary outcome
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4
Time frame: From baseline to week 4
8 secondary outcomes
TWSTRS, Single interventional effect
Time frame: From week 10-24 to week 14-28, from week 20-48 to week 24-52, from week 30-72 to week 34-76, and from week 40-96 to week 44-100
TWSTRS, overall interventional effect
Time frame: From study baseline to week 14-28, 24-52, 34-76, and 44-100
Global Assessment of Efficacy by Investigator (GAEI)
Time frame: Week 10-24, 20-48, 30-72, and 40-96
Subject Evaluation of Global Response (PEGR)
Time frame: Week 10-24, 20-48, 30-72, and 40-96
Time from last injection session to onset of treatment effect as given by subjective subject assessment
Time frame: Up to 4 weeks from last injection session
Time from last injection session to waning of treatment effect as rated by subjective subject assessment
Time frame: Up to 24 weeks from last injection session
Duration of treatment effect
Time frame: Up to 24 weeks from last injection session
Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline
Time frame: From study baseline up to week 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- Results publicationDressler D, Kupsch A, Paus S, Seitzinger A, Gebhardt B. Sustained efficacy of Incobotulinumtoxin-A (Xeomin®; Botulinum Neurotoxin Type-A, free from Complexing Proteins) in Long-Term Treatment of Cervical Dystonia. European Journal of Neurology 18 (Suppl. 2): 482, 2011.
- Results publication: PubMed 23687362Dressler D, Paus S, Seitzinger A, Gebhardt B, Kupsch A. Long-term efficacy and safety of incobotulinumtoxinA injections in patients with cervical dystonia. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1014-9. doi: 10.1136/jnnp-2012-303608. Epub 2013 May 18.
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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.
Prof. Dirk Dressler, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NT 201 in people with Cervical Dystonia, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
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 6 inclusion and 0 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 4 Jun 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 Germany. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4 (time frame: From baseline to week 4). 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 NCT00541905, 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 4 Jun 2013.