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Sponsors and Collaborators: |
Fralex Therapeutics PharmaNet McDougall Scientific Limited |
---|---|
Information provided by: | Fralex Therapeutics |
ClinicalTrials.gov Identifier: | NCT00450905 |
This study is being performed to determine the safety and efficacy of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain associated with Fibromyalgia.
Condition | Intervention | Phase |
---|---|---|
Fibromyalgia Pain |
Device: PRIMA Device |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Evaluation of a Low-Frequency Investigational Device Employing Neuromodulation Therapy in Patients With Fibromyalgia |
Estimated Enrollment: | 200 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Lancaster, California, United States, 93534 | |
La Jolla, California, United States, 92037 | |
Palmdale, California, United States, 93550 | |
Garden Grove, California, United States, 92845 | |
Encinitas, California, United States, 92024 | |
Murrieta, California, United States, 92563 | |
United States, Florida | |
Winter Park, Florida, United States, 32789 | |
West Palm Beach, Florida, United States, 33409 | |
Gainsville, Florida, United States, 32610 | |
United States, Kentucky | |
Lexington, Kentucky, United States, 40503 | |
United States, Minnesota | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
New York, New York, United States, 10003 | |
Rochester, New York, United States, 14642-8604 | |
United States, North Carolina | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Pennsylvania | |
Altoona, Pennsylvania, United States, 16602 | |
United States, Washington | |
Spokane, Washington, United States, 99216 | |
Seattle, Washington, United States, 98104 | |
Canada, Ontario | |
Ottawa, Ontario, Canada, K1H 1A2 | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Toronto, Ontario, Canada, M2N 6K7 | |
Toronto, Ontario, Canada, M9W 4L6 |
Study ID Numbers: | F06001 |
Study First Received: | March 21, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00450905 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Chronic musculoskeletal pain secondary to Fibromyalgia |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Neoplasm Metastasis Pain Rheumatic Diseases |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Nervous System Diseases Rheumatic Diseases |