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NCT00233519 · ClinicalTrials.gov registry record · Phase 1
Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)
A Phase 1 study of Myotonic Dystrophy, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT00233519: Completed Phase 1 study of Myotonic Dystrophy, sponsored by University of Rochester.
NCT00233519 is a Phase 1 study of Myotonic Dystrophy that has completed, run by University of Rochester. The registered enrollment target is 17 participants, below the 854-participant average among 9 other Myotonic Dystrophy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00233519, a Phase 1 study of Myotonic Dystrophy, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to investigate the safety and feasibility of daily subcutaneous injections of recombinant IGF1 complexed with IGF binding protein 3 (SomatoKine-INSMED) as a treatment for muscle wasting and weakness in myotonic dystrophy type 1.
Primary Outcome
Safety and tolerability was measured via interval laboratory studies,electrocardiograms, echocardiograms, ultrasounds of the abdomen and pelvis, dual energy x-ray absorptiometry (DEXA) studies, chest and neck x-rays, and serial physical examinations. The participants had six inpatient evaluations at the University of Rochester General Clinical Research Center (Weeks 0, 8, 16, 24, 28, and 40) and nine outpatient evaluations. Patients also completed side effects diaries to record any adverse event
Conditions Studied
Interventions
- DRUG SomatoKine/IPLEX
Study Locations (1)
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
What the finished NCT00233519 record still lists
NCT00233519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 854-participant average among 9 other Myotonic Dystrophy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Myotonic Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which SomatoKine/IPLEX is the first listed.
NCT00233519 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00233519 about?
NCT00233519 is a clinical study titled "Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)". The aim of this study is to investigate the safety and feasibility of daily subcutaneous injections of recombinant IGF1 complexed with IGF binding protein 3 (SomatoKine-INSMED) as a treatment for muscle wasting and weakness in myotonic dystrophy type 1.
What is the current status of trial NCT00233519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2005-11. Estimated completion is 2008-05.
What conditions does trial NCT00233519 study?
This clinical trial studies the following conditions: Myotonic Dystrophy.
What interventions are being tested in trial NCT00233519?
The interventions under investigation include: SomatoKine/IPLEX (DRUG).
Who is sponsoring clinical trial NCT00233519?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00233519 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00233519's enrollment target sits among peer trials
17 10th of 9 the lowest of 9 other Myotonic Dystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myotonic Dystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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