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Sponsored by: |
Avigen |
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Information provided by: | Avigen |
ClinicalTrials.gov Identifier: | NCT00532532 |
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity associated with multiple sclerosis. This study has three purposes:
Condition | Intervention | Phase |
---|---|---|
Muscle Spasticity |
Drug: tolperisone HCl |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis |
Estimated Enrollment: | 150 |
Study Start Date: | September 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
AV650 low dose
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Drug: tolperisone HCl
Low dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
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2: Experimental
AV650 high dose
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Drug: tolperisone HCl
High dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
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3: Experimental
Placebo
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Drug: tolperisone HCl
Placebo three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
University Hospital Hradec Kralove | |
Hradec Kralove, Czech Republic, 50005 | |
University Hospital Plzen | |
Plzen, Czech Republic, 30460 | |
University Hospital Motol | |
Praha, Czech Republic, 15006 | |
Annes University Hospital | |
Brno, Czech Republic, 65691 | |
Germany | |
Facharzt fur Neurologie | |
Bad Saarow, Germany, 15526 | |
Neurological practice | |
Bochum, Germany, 44805 | |
Neuro-Consil GmbH | |
Dusseldorf, Germany, 40212 | |
Facharztin fur Neurologie und Psychiatrie | |
Berlin, Germany, 12555 | |
Asklepios Klinik Nord-Heidberg | |
Hamburg, Germany, D022417 | |
X-pert-med GmbH | |
Graefelfing, Germany, 82166 | |
Private practice | |
Berlin, Germany, D-13156 | |
Facharzt fur Neurologie und Psychiatrie | |
Berlin, Germany, 13053 | |
Neurological practice | |
Koln, Germany, 50767 | |
Russian Federation | |
Institute of Human Brain | |
St. Petersburg, Russian Federation, 194291 | |
Leningrad Regional Clinical Hospital | |
St. Petersburg, Russian Federation, 197376 | |
Nikolaevskaya Hospital, Complex Rehabilitation Department | |
St. Petersburg, Russian Federation, 198510 | |
City Hospital #33 | |
Nizhniy Novgorod, Russian Federation, 603076 | |
Regional Clinical Hospital named Semashko | |
Nizhniy Novgorod, Russian Federation, 603126 | |
Serbia | |
Clinical Center Nis Clinic of Neurology | |
Nis, Serbia, 18000 | |
Clinical Center of Serbia Institute of Neurology | |
Belgrade, Serbia, 11000 | |
Ukraine | |
Institute of Clinical Radiology of the Scientific Centre of Radiation Medicine of the AMS of Ukraine | |
Kyiv, Ukraine, 03115 | |
M.O.Semashko Republican Clinical Hospital | |
Simferopol, Ukraine, 95017 | |
Central Clinical Hospital Ukrzalinznytsi (Dept. Neur. No. 3) | |
Kharkiv, Ukraine, 61018 | |
Central Clinical Hospital Ukrzalinznytsi (Dept. Neur. No. 1) | |
Kharkiv, Ukraine, 61018 | |
Odesa Regional Psychoneurological Dispensary | |
Odesa, Ukraine, 65014 | |
Uzhgorod Regional Centre of Neurosurgery and Neurology | |
Uzhorod, Ukraine, 88018 | |
Ivano-Frankivsk Regional Clinical Hospital | |
Ivano-Frankivsk, Ukraine, 76008 | |
Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine | |
Kharkiv, Ukraine, 61068 |
Study Director: | Glenn Morrison, MSc, PhD | Avigen, Inc. |
Responsible Party: | Avigen, Inc. ( Glenn Morrison, Ph.D. ) |
Study ID Numbers: | AV650-018 |
Study First Received: | September 18, 2007 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00532532 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health |
Multiple sclerosis |
Tolperisone Autoimmune Diseases Demyelinating Diseases Sclerosis Demyelinating diseases Signs and Symptoms Muscle Spasticity |
Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Demyelinating Autoimmune Diseases, CNS Neurologic Manifestations Autoimmune Diseases of the Nervous System |
Neuromuscular Manifestations Pathologic Processes Immune System Diseases Therapeutic Uses Muscle Relaxants, Central Physiological Effects of Drugs |
Nervous System Diseases Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |