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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 March 2015
• Main ID: NCT00712426
• Date of registration: 08/07/2008
• Prospective Registration: Yes
• Primary sponsor: Massachusetts General Hospital
• Public title: Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E) CREST-E
• Scientific title: Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
• Date of first enrolment: September 2009
• Target sample size: 553
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00712426
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Canada, New Zealand, United States

Contacts

• Name: Steven M Hersch, MD, PhD
• Affiliation: Massachusetts General Hospital

• Name: Diana Rosas, MD, MS
• Affiliation: Massachusetts General Hospital

• Name: Giovanni Schifitto, MD
• Affiliation: University of Rochester Clinical Trial Coordination Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female ages 18 or older.

- Clinical features of HD AND confirmatory family history of HD; OR Clinical features
of HD AND CAG repeat expansion greater or equal to 36.

- Stage I or II of illness (TFC greater or equal to 7).

- Ambulatory and not requiring skilled nursing care at the time of enrollment.

- Must be capable of providing informed consent and complying with trial procedures.

- Additional inclusion criteria apply.

Exclusion Criteria:

- History of known sensitivity or intolerability to creatine monohydrate.

- Exposure to any investigational drug within 30 days of randomization (Baseline
visit).

- Use of supplemental creatine at a dose greater than 10 grams within 30 days of
randomization (Baseline visit).

- Screening laboratory abnormalities that in the judgment of the investigator would
jeopardize safe conduct of study.

- Clinical evidence of unstable medical illness.

- Clinical evidence of unstable psychiatric illness.

- Additional exclusion criteria apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: Creatine Monohydrate

Drug: Placebo

Primary Outcome(s)

Change in Total Functional Capacity [Time Frame: Minimum 12 months up to 48 months]

Secondary Outcome(s)

Clinical symptoms (changes in other UHDRS scores); safety (frequency of adverse events); tolerability (proportion of subjects completing study at assigned dosage level), quality of life, other biological markers. [Time Frame: Duration of the trial]

Secondary ID(s)

2007P000827

U01AT000613

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Complementary and Integrative Health (NCCIH)

University of Rochester