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Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

NCT00712426 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 553

Last updated 2016-03-11

No results posted yet for this study

Summary

Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available.Creatine monohydrate is considered a nutritional supplement. The purpose of CREST-E is to test whether high-dose creatine can slow the progressive functional decline that occurs in persons 18 years or older with early clinical features of HD. The long-term safety, tolerability and effectiveness of up to 40 grams daily creatine compared to placebo is studied. A variety of biological processes are assessed for markers of disease activity or progression and creatine effects. Up to 50 active research centers globally will enroll 650 subjects.

Conditions

Interventions

DRUG

Creatine Monohydrate

Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration

DRUG

Placebo

Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Steven M Hersch, MD, PhD · Massachusetts General Hospital

  • Giovanni Schifitto, MD · University of Rochester Clinical Trial Coordination Center

  • Diana Rosas, MD, MS · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States
  • Australia
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00712426 on ClinicalTrials.gov