Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00712426




Registration number
NCT00712426
Ethics application status
Date submitted
8/07/2008
Date registered
10/07/2008
Date last updated
11/03/2016

Titles & IDs
Public title
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
Scientific title
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
Secondary ID [1] 0 0
U01AT000613
Secondary ID [2] 0 0
2007P000827
Universal Trial Number (UTN)
Trial acronym
CREST-E
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Creatine Monohydrate
Treatment: Drugs - Placebo

Active comparator: A - Randomized to receive creatine monohydrate (up to 40 grams daily)

Placebo comparator: B - Randomized to receive placebo (up to 40 grams daily)


Treatment: Drugs: Creatine Monohydrate
Up to 40 grams daily, powder form creatine monohydrate, taken for the trial duration

Treatment: Drugs: Placebo
Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Total Functional Capacity
Timepoint [1] 0 0
Minimum 12 months up to 48 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Duration of the trial

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
553
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [2] 0 0
Neurodegenerative Disorders Research - Subiaco
Recruitment postcode(s) [1] 0 0
2145 - Wentworthville
Recruitment postcode(s) [2] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Canada
State/province [29] 0 0
Manitoba
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
New Zealand
State/province [31] 0 0
Auckland
Country [32] 0 0
New Zealand
State/province [32] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Massachusetts General Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Rochester
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Center for Complementary and Integrative Health (NCCIH)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steven M Hersch, MD, PhD
Address 0 0
Massachusetts General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00712426