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NCT00818389 · ClinicalTrials.gov registry record · Phase 2
Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT00818389: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.
NCT00818389 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00818389, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effectiveness of lithium combined with riluzole to riluzole combined with placebo in people with amyotrophic lateral sclerosis.
Primary Outcome
ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 \& 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline.
Interventions
- DRUG placebo
- DRUG Riluzole
- DRUG Lithium Carbonate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
Why NCT00818389 stopped before completion
NCT00818389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00818389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00818389 about?
NCT00818389 is a clinical study titled "Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)". The purpose of this study is to compare the effectiveness of lithium combined with riluzole to riluzole combined with placebo in people with amyotrophic lateral sclerosis.
What is the current status of trial NCT00818389?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2009-01. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00818389?
The interventions under investigation include: placebo (DRUG), Riluzole (DRUG), Lithium Carbonate (DRUG).
Who is sponsoring clinical trial NCT00818389?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00818389's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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