Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Avigen |
---|---|
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 |
---|---|
1: Experimental
AV650 low dose
|
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
|
2: Experimental
AV650 high dose
|
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
|
3: Experimental
Placebo
|
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
|
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 History of Changes |
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 Signs and Symptoms Muscle Spasticity Multiple Sclerosis Muscular Diseases |
Musculoskeletal Diseases Muscle Hypertonia Muscle Relaxants, Central Demyelinating Autoimmune Diseases, CNS Neurologic Manifestations Peripheral Nervous System Agents Autoimmune Diseases of the Nervous System |
Tolperisone Neuromuscular Manifestations Autoimmune Diseases Demyelinating Diseases Immune System Diseases Physiological Effects of Drugs Nervous System Diseases Neuromuscular Agents Sclerosis Pharmacologic Actions Signs and Symptoms Muscle Spasticity |
Pathologic Processes Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Therapeutic Uses Muscle Relaxants, Central Neurologic Manifestations Demyelinating Autoimmune Diseases, CNS Peripheral Nervous System Agents Central Nervous System Agents Autoimmune Diseases of the Nervous System |