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NCT00592995 · ClinicalTrials.gov registry record · Phase 2
Creatine Safety and Tolerability in Premanifest HD: PRECREST
A Phase 2 study of Huntington Disease, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT00592995 is a Phase 2 study of Huntington Disease that has completed, run by Massachusetts General Hospital. The registered enrollment target is 64 participants, below the 634-participant average among 35 other Huntington Disease trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00592995, a Phase 2 study of Huntington Disease, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
PRECREST is a two phase protocol for Huntington's disease in which 60 premanifest and at-risk subjects will first be randomized into a double blind placebo controlled dose titration study bringing them to 30 grams daily or their highest tolerated dose. This phase will establish the highest tolerable doses in premanifest HD and permit the detection of toxicity and intolerability with attribution to active compound versus placebo, and enable a dose response assessment of biomarkers. In the second phase, all subjects will enter a year long open-label treatment on 30 grams daily (or their highest dose) of creatine to assess long term exposure to high dose creatine and its long term impact on various biomarkers.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Creatine monohydrate
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2007-12 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00592995
The ClinicalTrials.gov registry entry for NCT00592995 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 634-participant average among 35 other Huntington Disease trials with a reported enrollment target (90% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Huntington Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00592995 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00592995 about?
NCT00592995 is a clinical study titled "Creatine Safety and Tolerability in Premanifest HD: PRECREST". PRECREST is a two phase protocol for Huntington's disease in which 60 premanifest and at-risk subjects will first be randomized into a double blind placebo controlled dose titration study bringing them to 30 grams daily or their highest tolerated dose. This phase will establish the highest tolerable...
What is the current status of trial NCT00592995?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2007-12. Estimated completion is 2012-09.
What conditions does trial NCT00592995 study?
This clinical trial studies the following conditions: Huntington Disease.
What interventions are being tested in trial NCT00592995?
The interventions under investigation include: Placebo (DRUG), Creatine monohydrate (DRUG).
Who is sponsoring clinical trial NCT00592995?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00592995 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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