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A Phase 3b, Prospective, Multicenter, Open-Label Extension Study to Assess Long Term Safety and Efficacy of DYSPORT Using 2mL Dilution in Adults with Cervical Dystonia
A phase 3b, prospective, multicenter, open-label extension study to assess the long term safety and effectiveness of Dysport using 2 mL dilution in adults with cervical dystonia. This study is open to subjects who have completed the Dysport double-blind study protocol A-TL-52120-169 or are eligible for early entry, from enrollment into the 169 study.Clinical Trial Rationale:The current USPI allows for only one dilution of Dysport: 500 U in 1 mL volume. Feedback obtained from scientific experts and Investigators at medical advisory boards and in market research data has pointed to the lack of scientific data supporting a 2 mL dilution as an obstacle to providing appropriate, safe and effective Dysport utilisation in the USA for subjects suffering from CD. Despite the lack of labelled information, the 2 mL dilution with Dysport reflects real world clinical practice in the USA.The addition of data in the USPI supporting the safety and efficacy of a 2 mL dilution with Dysport will provide the clinician more flexibility in injection volume range to better equip them to meet the needs of a broader spectrum of subjects with CD. The primary objective of the study is to assess long term safety of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). Secondary objective is to assess long term efficacy of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). The study consists of up to three treatment cycles of Dysport using the 2 mL dilution scheme. Approximately 132 male and female subjects with CD will be enrolled. The primary efficacy endpoint is the change from treatment cycle baseline (defined as Day 1 in each cycle) in TWSTRS total score at Week 4 and Week 12 visits, in Treatment Cycles 1, 2, and 3. Statistical analyses will be performed by an external CRO. Statistical evaluation will be performed by using SAS.
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion Criteria
- Subjects enrolled in Study 169 that have no ongoing adverse events, which in the opinion of the Investigator are related to study treatment and that precludes them from receiving continuing therapy
- Completed Study 169, or completed all study visits up to and including Week 4 and in the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total score at Week 4 compared to their baseline TWSTRS total score in the double-blind study, and in the Investigator's clinical judgment, would benefit from Dysport for CD.
- Diagnosis of pure retrocollis or pure anterocollis
- Requirement for botulinum toxin injection to site(s) for disorders other than CD and unable to avoid such treatment(s) for the duration of the study
- Known hypersensitivity to botulinum toxin or related compounds, or any component in the study drug formulation
- Allergy to cow's milk protein
- USC Keck School of Medicine, Los Angeles, California, 90033
- Parkinson's and Movement Disorder Institute, Fountain Valley, California, 92708
- Loma Linda University Healthcare, Department of Neurology, Loma Linda, California, 92354
- East Bay Physician's Group, Berkeley, California, 94705
- UC Davis Medical Center, Sacramento, California, 95817
- Sutter Cancer Center, Sacramento, California, 95816
- Movement Disorders Center of Arizona, LLC, Scottsdale, Arizona, 85258
- University of Arizona, Tucson, Arizona, 85724
- OHSU Center for Health and Healing, Portland, Oregon, 97239
- Advanced Neurosciences Research, Fort Collins, Colorado, 80528
- Puget Sound Neurology, Tacoma, Washington, 98409
- North Texas Movement Disorders Institute, Bedford, Texas, 76201
- University of Texas Health Science Center at Houston, Houston, Texas, 77030
- Baylor College of Medicine, Houston, Texas, 77030
- International Clinical Research Institute, Overland Park, Kansas, 66210
- Kansas City Bone & Joint Clinic, Kansas City, Kansas, 66211
- Rehabilitation Consultants, PA, Eagan, Minnesota, 55121
- University of Alabama at Birmingham, Birmingham, Alabama, 35294
- Emerald Coast Center for Neurological Disorders, Pensacola, Florida, 32514
- University of Cincinnati Physicians Company, LLC, Cincinnati, Ohio, 45267
- NeuroTrials Research Inc., Atlanta, Georgia, 30342
- Emory University, Atlanta, Georgia, 30329