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| Sponsor: | IMPAX Laboratories, Inc. |
|---|---|
| Information provided by: | IMPAX Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT00914290 |
Purpose
To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).
| Condition | Intervention | Phase |
|---|---|---|
|
Spasticity Multiple Sclerosis |
Drug: IPX056 Drug: Baclofen |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis |
| Estimated Enrollment: | 28 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| IPX056: Experimental |
Drug: IPX056
Encapsulated IPX056
|
| Baclofen: Active Comparator |
Drug: Baclofen
Encapsulated baclofen capsule
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Northwest NeuroSpecialists, PLLC | Recruiting |
| Tucson, Arizona, United States, 85741 | |
| Contact: IPX056-B09-01 Study Coordinator 520-742-1833 | |
| United States, Colorado | |
| University of Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: IPX056-B09-01 Study Coordinator 303-724-2198 | |
| United States, Florida | |
| Meridien Research | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: IPX056-B09-01 Study Coordinator 813-877-8839 | |
| United States, Indiana | |
| Fort Wayne Neurological Center | Recruiting |
| Fort Wayne, Indiana, United States, 46805 | |
| Contact: IPX056-B09-01 Study Coordinator 260-460-3257 | |
| United States, Kansas | |
| MidAmerica Neuroscience Institute | Recruiting |
| Lenexa, Kansas, United States, 66214 | |
| Contact: IPX056-B09-01 Study Coordinator 913-894-1500 ext 166 | |
| United States, Michigan | |
| QUEST Research Institute | Recruiting |
| Bingham Farms, Michigan, United States, 48025 | |
| Contact: IPX056-B09-01 Study Coordinator 248-644-7770 | |
| United States, Montana | |
| Great Falls Cllinic | Recruiting |
| Great Falls, Montana, United States, 59405 | |
| Contact: IPX056-B09-01 Study Coordinator 406-268-3923 | |
| United States, New York | |
| Empire Neurology, PC | Recruiting |
| Latham, New York, United States, 12110 | |
| Contact: IPX056-B09-01 Study Coordinator 802-447-7577 | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: IPX056-B09-01 Study Coordinator 516-663-9582 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: IPX056-B09-01 Study Coordinator 336-716-1704 | |
| United States, Texas | |
| Central Texas Neurology Consultants | Recruiting |
| Round Rock, Texas, United States, 78681 | |
| Contact: IPX056-B09-01 Study Coordinator 512-218-1222 | |
| Study Director: | Impax Study Director | Impax Laboratories (Impax Pharmaceuticals, a division of Impax Laboratories) |
More Information
| Responsible Party: | Impax Laboratories ( Impax Pharmaceuticals, a division of Impax Laboratories ) |
| Study ID Numbers: | IPX056-B09-01 |
| Study First Received: | June 2, 2009 |
| Last Updated: | September 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00914290 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Neuromuscular Agents Signs and Symptoms Multiple Sclerosis Pathologic Processes Musculoskeletal Diseases Muscle Hypertonia Muscle Relaxants, Central Therapeutic Uses Autoimmune Diseases of the Nervous System Neuromuscular Manifestations Autoimmune Diseases |
Immune System Diseases Demyelinating Diseases Nervous System Diseases Baclofen Sclerosis Pharmacologic Actions Muscle Spasticity Muscular Diseases GABA Agonists GABA Agents Demyelinating Autoimmune Diseases, CNS Neurologic Manifestations Peripheral Nervous System Agents Central Nervous System Agents |