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Sponsored by: |
Ipsen |
---|---|
Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00276315 |
To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of hemifacial spasm.
Condition | Intervention | Phase |
---|---|---|
Hemifacial Spasm |
Drug: Botulinum type A toxin (Dysport®) - one single injection |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicentre, Randomised, Assessor-Blind, Parallel Groups, Reference Drug Controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection of Dysport® for the Treatment of Hemifacial Spasm |
Estimated Enrollment: | 348 |
Study Start Date: | December 2005 |
Study Completion Date: | January 2007 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Neurology Department, Peking Union Medical College Hospital | |
Beijing, China, 100730 | |
Neurology Department, Sir Run Run Shaw Hospital, Zhejiang University | |
Hangzhou, China, 310016 | |
Neurology Department, Shanghai Ruijin Hospital | |
Shanghai, China, 200025 | |
Neurology Department, Guangdong Provincial People's Hospital | |
Guangdong, China, 510080 |
Study Director: | Jing-dong Ma, MD | Ipsen |
Study ID Numbers: | A-38-52120-074 |
Study First Received: | January 12, 2006 |
Last Updated: | July 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00276315 |
Health Authority: | China: State Food and Drug Administration |
Mouth Diseases Spasm Signs and Symptoms Botulinum Toxins |
Neurologic Manifestations Stomatognathic Diseases Botulinum Toxin Type A Hemifacial Spasm |
Neuromuscular Manifestations Physiological Effects of Drugs Nervous System Diseases |
Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions |