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COMPLETED 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

NCT00577577 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 69 participants
Start Date 2007-12
Est. Completion 2008-12-29
Phase Phase 2

Sponsor

Insmed Incorporated

11 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insmed Incorporated, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00577577 reports 12 study locations spanning 10 distinct geographic areas — top geographies include California, Texas, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00577577?

The interventions under investigation include: placebo (DRUG), rhIGF-I/rhIGFBP-3 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00577577?

This trial is sponsored by Insmed Incorporated, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial