Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00288509
First received: February 7, 2006
Last updated: June 17, 2010
Last verified: June 2010
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Purpose
The aim of this study is to assess longer term safety and effectiveness of Dysport®.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Dystonia |
Drug: abobotulinumtoxinA (Dysport) 250-1000 units |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline [ Time Frame: Week 4 follow-up visit ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 108 |
| Study Start Date: | February 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: abobotulinumtoxinA (Dysport) 250-1000 units
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288509
Locations
| United States, Arizona | |
| Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| The Parkinson's and Movement Disorder Institute | |
| Fountain Valley, California, United States, 92708 | |
| USC School of Medicine | |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| University of Florida, Dept of Neurology | |
| Gainesville, Florida, United States, 32610 | |
| University of Miami, Dept of Neurology | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University School of Medicine, Wesley Woods Health Center | |
| Atlanta, Georgia, United States, 30329 | |
| United States, Iowa | |
| University of Iowa, Dept of Neurology | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Michigan | |
| Wayne State University Medical Center | |
| Southfield, Michigan, United States, 48034 | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12205 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| Columbia University Medical Center, Neurological Institute | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Texas | |
| University of Texas Southwest Medical Center, Movement Disorder Clinic | |
| Dallas, Texas, United States, 75309 | |
| Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic | |
| Houston, Texas, United States, 77030 | |
| Russian Federation | |
| Clinic "Cecil Plus" | |
| Moscow, Russian Federation, 125047 | |
| Scientific Research Institute of Neurology, RAMS | |
| Moscow, Russian Federation, 123367 | |
| St Petersburg Pavlov State Medical University | |
| St Petersburg, Russian Federation, 197022 | |
| Municipal Multi-Speciality Hospital #2 | |
| St Petersburg, Russian Federation, 194354 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Jean-Loic Robin, MD | Ipsen |
More Information
Publications:
| Responsible Party: | Jean-Loic Robin, Ipsen |
| ClinicalTrials.gov Identifier: | NCT00288509 History of Changes |
| Other Study ID Numbers: | Y-47-52120-731 |
| Study First Received: | February 7, 2006 |
| Results First Received: | January 6, 2010 |
| Last Updated: | June 17, 2010 |
| Health Authority: | United States: Food and Drug Administration Russia: Ministry of Health of the Russian Federation |
Additional relevant MeSH terms:
|
Dystonia Dystonic Disorders Torticollis Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Movement Disorders Central Nervous System Diseases Botulinum Toxins, Type A Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013