Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
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| ClinicalTrials.gov Identifier: NCT00288509 |
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Recruitment Status :
Completed
First Posted : February 8, 2006
Results First Posted : April 2, 2010
Last Update Posted : November 22, 2019
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
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Brief Summary:
The aim of this study is to assess longer term safety and effectiveness of Dysport®.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Dystonia | Biological: Botulinum toxin type A | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 108 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | January 2008 |
| Actual Study Completion Date : | January 2008 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dysport
250-1000 units
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Biological: Botulinum toxin type A
In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety & efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.
Other Name: AbobotulinumtoxinA (Dysport®) |
Primary Outcome Measures :
- Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline [ Time Frame: Week 4 follow-up visit ]TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.
Secondary Outcome Measures :
- Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline [ Time Frame: Week 4 follow-up visit ]TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.
- Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline [ Time Frame: Week 4 follow-up visit ]TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.
- Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline [ Time Frame: Week 4 follow-up visit ]TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
- Returned to pre-treatment status as judged by the Investigator
Exclusion Criteria:
- Pure anterocollis or pure retrocollis
- Known antibodies to botulinum toxin type A
- Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
- Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288509
Locations
Show 18 study locations
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00288509 |
| Other Study ID Numbers: |
Y-47-52120-731 2005-002429-29 ( EudraCT Number ) |
| First Posted: | February 8, 2006 Key Record Dates |
| Results First Posted: | April 2, 2010 |
| Last Update Posted: | November 22, 2019 |
| Last Verified: | November 2019 |
Additional relevant MeSH terms:
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Dystonia Dystonic Disorders Torticollis Dyskinesias Neurologic Manifestations Nervous System Diseases Movement Disorders Central Nervous System Diseases Botulinum Toxins Botulinum Toxins, Type A |
abobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |