Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E) (CREST-E)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00712426|
Recruitment Status : Terminated (Results of an interim analysis showed that it was unlikely that creatine was effective in slowing loss of function in early symptomatic Huntington's Disease.)
First Posted : July 10, 2008
Last Update Posted : March 11, 2016
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Huntington's Disease||Drug: Creatine Monohydrate Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||553 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||January 2015|
Active Comparator: A
Randomized to receive creatine monohydrate (up to 40 grams daily)
Drug: Creatine Monohydrate
Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration
Other Name: HD-02
Placebo Comparator: B
Randomized to receive placebo (up to 40 grams daily)
Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
Other Name: Dextrose
- Change in Total Functional Capacity [ Time Frame: Minimum 12 months up to 48 months ]Study duration depends on each subject's calendar date of enrollment.
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712426
|Principal Investigator:||Steven M Hersch, MD, PhD||Massachusetts General Hospital|
|Principal Investigator:||Giovanni Schifitto, MD||University of Rochester Clinical Trial Coordination Center|
|Principal Investigator:||Diana Rosas, MD, MS||Massachusetts General Hospital|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital|
|Other Study ID Numbers:||
U01AT000613 ( U.S. NIH Grant/Contract )
|First Posted:||July 10, 2008 Key Record Dates|
|Last Update Posted:||March 11, 2016|
|Last Verified:||February 2016|
Total Functional Capacity
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn