CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Creatine monohydrate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00592995
NCT00592995Phase 2Completed
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Creatine Safety and Tolerability in Premanifest HD: PRECREST

Massachusetts General Hospital·interventional·Posted Jan 14, 2008·Updated Feb 10, 2014

In Brief

A Phase 2 clinical trial evaluating Creatine monohydrate and Placebo for Huntington Disease. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuntington Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 14, 2008
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 18.5 years ago

Interventions

Creatine monohydratedrug

10 to 30 grams daily

Placebodrug

10 to 30 grams daily