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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: Completed Phase 2 study of Myotonic Dystrophy Type 1, sponsored by Insmed Incorporated.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The 6MWT measured the distance in meters that participants were able to walk over a total of six minutes. After a 10 minute resting period, the participants completed the 6MWT on a hard, flat surface at baseline and at Week 24.
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 |
What the finished NCT00577577 record still lists
NCT00577577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,063-participant average among 3 other Myotonic Dystrophy Type 1 trials with a reported enrollment target (94% lower).
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 lists 12 locations in 10 states (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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