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NCT00035815 · ClinicalTrials.gov registry record · Phase 3
Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
NCT00035815: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT00035815 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 330 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00035815, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome measure was the rate of change in the MMT score. MMT involved the examination of 34 muscle groups with standard positioning. The final MMT score represented an average of the 34 muscles examined, and ranged from 10 to 0(10 normal strength, 0 paralyzed). The individual muscle score was based on the medical research council (MRC) grading scale (1-5) modified to a 10 point system corresponding to the MRC modifications of plus and minus (5, 5-,4+,4,4-,3+,3, 3-,2,1,0; with 5 being
Interventions
- DRUG Placebo
- DRUG Insulin like growth factor, type 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2003-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00035815 record still lists
NCT00035815 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00035815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00035815 about?
NCT00035815 is a clinical study titled "Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial". 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. Examinati...
What is the current status of trial NCT00035815?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2003-06. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00035815?
The interventions under investigation include: Placebo (DRUG), Insulin like growth factor, type 1 (DRUG).
Who is sponsoring clinical trial NCT00035815?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00035815's enrollment target sits among peer trials
330 1066th of 2000 higher than 927 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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