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Sponsors and Collaborators: |
Insmed Muscular Dystrophy Association |
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Information provided by: | Insmed |
ClinicalTrials.gov Identifier: | NCT00577577 |
To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance, ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients
Condition | Intervention | Phase |
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Myotonic Dystrophy Type 1 |
Drug: rhIGF-I/rhIGFBP-3 Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Placebo Controlled, Randomized, Double-Blind Phase II Clinical Trial to Evaluate Tolerability, Safety and Efficacy Endpoints After Administration of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) for 24 Weeks in Adults With Myotonic Dystrophy Type 1 |
Estimated Enrollment: | 60 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Efficacy Measures:
Endurance, Ambulation, Cognitive function, Insulin resistance, Cholesterol and triglycerides, Muscle function and strength, Pain, Gastrointestinal function, Quality of life
MINIMUM INCLUSION CRITERIA
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (list is not inclusive):
Exclusion Criteria (list is not inclusive):
United States, California | |
University of California Irvine Medical Center; MDA, ALS and Neuromuscular Center | |
Orange, California, United States, 92868 | |
University of California, Davis | |
Sacramento, California, United States, 95817 | |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Washington University Medical School | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
University of Rochester, Neuromuscular Disease Center | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Oregon | |
Oregan Health and Science University | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
Universit of Texas Medical Branch | |
Galveston, Texas, United States, 77555-0539 | |
University of Texas Health Science Center | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84112 |
Study Chair: | Richard Moxley, M.D. | University of Rochester Neuromuscular Disease Center |
Responsible Party: | Insmed Incorporated ( Christy ONeal, Study Manager ) |
Study ID Numbers: | INSM-110-1001 |
Study First Received: | December 18, 2007 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00577577 |
Health Authority: | United States: Food and Drug Administration |
Myotonic Disorders Neurodegenerative Diseases Dystrophia myotonica 1 Insulin Myotonia atrophica Muscular Dystrophies Muscular Diseases Heredodegenerative Disorders, Nervous System |
Muscular Disorders, Atrophic Musculoskeletal Diseases Neuromuscular Diseases Genetic Diseases, Inborn Myotonic Dystrophy Atrophy Muscular dystrophy |
Hypoglycemic Agents Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |