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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03168711
The ClinicalTrials.gov registry entry for NCT03168711 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03168711 reports 0 study locations.
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.
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