Premanifest Huntington's Disease: Creatine Safety & Tolerability Extension Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01411150
• Date of registration: 04/08/2011
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: Premanifest Huntington's Disease: Creatine Safety & Tolerability Extension Study Pre-CREST-X
• Scientific title: Premanifest Huntington's Disease: Creatine Safety & Tolerability Extension Study
• Date of first enrolment: May 2009
• Target sample size: 38
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01411150
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Individuals who have completed the Pre-CREST Study.

- Individuals capable of providing independent informed consent and complying with
trial procedures.

Exclusion Criteria:

-Clinical evidence of unstable medical or psychiatric illness in the investigator's
judgment.

Additional eligibility criteria apply.



Age minimum: 26 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: Creatine Monohydrate

Primary Outcome(s)

Safety [Time Frame: 12 months]

Tolerability [Time Frame: 12 months]

Secondary Outcome(s)

Biological Markers of Disease Progression [Time Frame: 12 Months]

Clinical measures [Time Frame: 12 months]

Secondary ID(s)

2009P000642

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)