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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 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.

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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.

Conditions Studied

Interventions

  • DRUG SomatoKine/IPLEX

Study Locations (1)

New York

  • University of Rochester Medical Center - Rochester

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2005-11
Est. Completion 2008-05
Phase Phase 1

Sponsor

University of Rochester

636 total trials

What the Registry Record Tells You About NCT00233519

The ClinicalTrials.gov registry entry for NCT00233519 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 854-participant average among 9 other Myotonic Dystrophy trials with a reported enrollment target (98% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.