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

(ClinicalTrials.gov identifier: NCT00712426)

Purpose

Creatine has been shown to reduce brain shrinkage, extend survival in transgenic mouse models of HD, and to reduce oxidative stress markers in blood and brain.  In a preliminary clinical study in individuals with HD, creatine was shown to be safe, tolerable, and bioavailable to the brain.  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 will be studied in this Phase III study.  A variety of biological processes are assessed for markers of disease activity or progression and creatine effects.  Approximately 50 active research centers globally will enroll 650 subjects.

 

Study Type:

Interventional

Primary Outcome Measures:

  • 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.

Secondary Outcome Measures:

  • 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.

 

 

Estimated Enrollment:

650

Study Start Date:

September 2009

Estimated Study Completion Date:

June 2016

Estimated Primary Completion Date:

June 2016 (Final data collection date for primary outcome measure)

Eligibility:

Ages Eligible for Study:  

18 Years and older

Genders Eligible for Study:  

Both

Accepts Healthy Volunteers:  

No

 

Inclusion Criteria:

  • Male or female ages 18 or older.
  • Clinical features of HD AND confirmatory family history of HD; OR 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.

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.

Click here to view Clinical Trial Locations and Contacts

 

Want more info?

Contact: Huntington Study Group at 1-800-487-7671, or visit

http://www.huntington-study-group.org/HSGResearch/ClinicalTrialsObservationalStudiesinProgress/CRESTE/tabid/105/Default.aspx

or,

http://clinicaltrials.gov/ct2/show/NCT00712426?term=NCT00712426&rank=1