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NCT03168711 · ClinicalTrials.gov registry record · Phase 2
Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT03168711: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT03168711 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03168711, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a multi-center, 20-week study of inosine treatment. Study Objectives and Endpoints The primary objective of the study is to determine the safety and tolerability of oral administration of inosine (administered daily) dosed to moderately elevate serum urate over 20 weeks. The primary outcome measures will be 1. Safety, as measured by adverse events 2. Tolerability, defined as the ability of subjects to complete the entire 20-week study. As an exploratory objective, we will test the feasibility and utility of a smartphone application for monitoring symptoms and disease progression in patients with amyotrophic lateral sclerosis (ALS).
Primary Outcome
Safety will be assessed by the occurrence of adverse events such as kidney stones and gout (expected adverse events) in all participants receiving at least 1 dose of study drug
Interventions
- DRUG Placebo
- DRUG Inosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2020-01-07 |
| Phase | Phase 2 |
What the finished NCT03168711 record still lists
NCT03168711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03168711 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03168711 about?
NCT03168711 is a clinical study titled "Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS)". This is a multi-center, 20-week study of inosine treatment. Study Objectives and Endpoints The primary objective of the study is to determine the safety and tolerability of oral administration of inosine (administered daily) dosed to moderately elevate serum urate over 20 weeks. The primary outcom...
What is the current status of trial NCT03168711?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2017-10-01. Estimated completion is 2020-01-07.
What interventions are being tested in trial NCT03168711?
The interventions under investigation include: Placebo (DRUG), Inosine (DRUG).
Who is sponsoring clinical trial NCT03168711?
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 NCT03168711's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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