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Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial

NCT00035815 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2013-02-15

Study results available
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Summary

The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study participants will be followed for 2 years once enrolled. They will receive either placebo or the active IGF-I. Examinations will take place at approximately 6-month intervals.

Conditions

Interventions

DRUG

Insulin like growth factor, type 1

0.05 mg per kg body weight given subcutaneously twice daily

DRUG

Placebo

The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • ALS Association

    collaborator OTHER

  • Cephalon

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Eric Sorenson, M.D. · Department of Neurology, Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-08-31
Completion
2007-12-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00035815 on ClinicalTrials.gov