Full Text View
Tabular View
No Study Results Posted
Related Studies
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
This study is currently recruiting participants.
Study NCT00712426   Information provided by Massachusetts General Hospital
First Received: July 8, 2008   Last Updated: September 24, 2009   History of Changes

July 8, 2008
September 24, 2009
September 2009
December 2014   (final data collection date for primary outcome measure)
To assess the effects of creatine monohydrate (HD-02) on the progression of functional decline in HD as measured by the change in the Total Functional Capacity (TFC) scale over 36 months. [ Time Frame: after approximately 163, 325, & 488 subjects have completed the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00712426 on ClinicalTrials.gov Archive Site
To assess the long-term safety and tolerability of creatine(HD-02) in HD, its effect on clinical symptoms, quality of life, and effect on biological outcome measures of HD progression as compared to placebo. [ Time Frame: after 50, 150, and 300 subjects have reached 12 months of follow-up and after 50% of the subjects have reached the 36 month visit ] [ Designated as safety issue: Yes ]
Same as current
 
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

The purpose of this study is to assess the effect of creatine on slowing the worsening of HD symptoms and to assess the safety of creatine in long-term use.

Subjects will participate in sixteen (16) study visits and eighteen (18) telephone contacts over three years.

Eligible subjects will receive either up to 40 grams powdered creatine monohydrate per day or matching placebo for a total of 36 months.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Huntington's Disease
  • Drug: Creatine Monohydrate (HD-02)
  • Drug: placebo
  • Active Comparator: Eligible subjects randomized into this arm will receive up to 40 grams powdered creatine monohydrate per day for a total of 36 months
  • Placebo Comparator: Eligible subjects randomized into this arm will receive up to 40 grams of placebo per day for a total of 36 months
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
650
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female age 18 or older.
  • Subjects must have clinical features of HD and a confirmatory family history of HD; OR CAG repeat expansion greater or equal to 36.
  • Subjects in Stage I or II of illness (TFC greater or equal to 7).
  • Subjects must be ambulatory and not requiring skilled nursing care at the time of enrollment.
  • Women of childbearing potential (i.e., those not postmenopausal or surgically sterile) must have a negative pregnancy test, be non-lactating and use adequate contraception methods during the study. Adequate birth control includes: abstinence; oral, implanted or injected contraceptives, e.g., birth control pills; intra-uterine device; barrier (e.g., vaginal ring or diaphragm/cervical cap with spermicide; transdermal patch and/or partner vasectomy). Reliable contraception must have been in use 30 days prior to the Baseline Visit.
  • Subjects currently taking psychotropic medications (including anti-depressants and neuroleptics) must be on stable dosages for at least 30 days prior to randomization.
  • Subjects must be capable of providing informed consent and complying with trial procedures.
  • Subjects must be able to take oral medication.

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 90 days of randomization (Baseline visit).
  • Use of supplemental Coenzyme Q10 at a dose greater than 600 milligrams daily within 90 days of randomization (Baseline visit). CoQ10 supplements totaling greater than 300mg daily are not allowed during the study but may be taken prior to the baseline visit.
  • Screening creatinine greater than 2.0 mg/dL.
  • Screening white blood cell count less than 3800/mm3.
  • Screening alanine aminotransferase greater than 2 times the upper limit of normal.
  • Screening laboratory abnormalities that in the judgment of the investigator would jeopardize safe conduct of study.
  • Current or history of substance (alcohol or drug) abuse within one year of randomization (Baseline visit).
  • Clinical evidence of unstable medical illness in the investigator's judgment.
  • Clinical evidence of unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression or suicidal ideation within 90 days of the Baseline visit.

Additional Exclusion Criteria for Imaging Sites:

  • Previously obtained MRI scans with evidence of infection, infarction or other focal lesions.
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body or any other known contra-indication to MRI.
Both
18 Years and older
No
Contact: Alejandra M Rodriguez, RN, BSN 617-726-5892 arodriguez16@partners.org
Contact: Karen C Hodgeman, CCRA (585) 273-5365 Karen.Hodgeman@ctcc.rochester.edu
United States
 
NCT00712426
Steven M. Hersch, MD, PhD, Massachusetts General Hospital
2007P000827, UO1AT000613
Massachusetts General Hospital
 
Principal Investigator: Steven M Hersch, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP