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NCT00577577 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1
A Phase 2 study of Myotonic Dystrophy Type 1, sponsored by Insmed Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 12
- Study locations
NCT00577577 is a Phase 2 study of Myotonic Dystrophy Type 1 that has completed, run by Insmed Incorporated. The registered enrollment target is 69 participants, below the 1,063-participant average among 3 other Myotonic Dystrophy Type 1 trials with a reported enrollment target (94% lower). The trial reports 12 study locations across 10 states.
The verdict
NCT00577577, a Phase 2 study of Myotonic Dystrophy Type 1, has completed, sponsored by Insmed Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 12
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG placebo
- DRUG rhIGF-I/rhIGFBP-3
Study Locations (12)
California
- University of California Irvine Medical Center; MDA, ALS and Neuromuscular Center - Orange
- University of California, Davis - Sacramento
Texas
- Universit of Texas Medical Branch - Galveston
- University of Texas Health Science Center - San Antonio
Kansas
- University of Kansas Medical Center - Kansas City
Maryland
- Johns Hopkins Hospital - Baltimore
Minnesota
- University of Minnesota - Minneapolis
Missouri
- Washington University Medical School - St Louis
New York
- University of Rochester, Neuromuscular Disease Center - Rochester
Ohio
- Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2007-12 |
| Est. Completion | 2008-12-29 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00577577
The ClinicalTrials.gov registry entry for NCT00577577 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,063-participant average among 3 other Myotonic Dystrophy Type 1 trials with a reported enrollment target (94% lower). The listed sponsor is Insmed Incorporated, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myotonic Dystrophy Type 1 appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00577577 reports 12 study locations spanning 10 distinct geographic areas - top geographies include California, Texas, Kansas.
Frequently Asked Questions
What is clinical trial NCT00577577 about?
NCT00577577 is a clinical study titled "Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1". 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
What is the current status of trial NCT00577577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2007-12. Estimated completion is 2008-12-29.
What conditions does trial NCT00577577 study?
This clinical trial studies the following conditions: Myotonic Dystrophy Type 1.
What interventions are being tested in trial NCT00577577?
The interventions under investigation include: placebo (DRUG), rhIGF-I/rhIGFBP-3 (DRUG).
Who is sponsoring clinical trial NCT00577577?
This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00577577 being conducted?
This trial has 12 study locations across California, Kansas, Maryland, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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