Creatine Safety and Tolerability in Premanifest HD: PRECREST

Completed · Phase 2 · Has a placebo group

Conditions studied: Huntington Disease

In brief

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.

Key facts

Study ID

NCT00592995

Run by

Massachusetts General Hospital

People needed

64

Starts

2007-12-01

Expected to finish

2012-09-01

Last updated by the study team

2014-02-10

Who can join

Age: 26 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Expansion positive or 50% at risk for HD and not diagnosed clinically

You may not qualify if…

• Unstable medical conditions
• Additional inclusion and exclusion criteria apply.

Where it is running

• Massachusetts General Hospital — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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