CREST-E

Overview

Status: Recruiting
Keywords: Huntington's Disease (HD) , CREST-E , Creatine Treatment Trial , Multi-Center
IRB Number: 00040174
Specialty: Neurology, Neurology, Neurology
Sub Specialties: Movement Disorders, Chorea, Huntington Disease

Brief Summary

The is a controlled (double-blind) multi-center Phase III safety, tolerability, and efficacy trial of 40-grams daily creatine in Huntington’s disease (HD) patients. Creatine monohydrate (“creatine”) is a nutritional supplement that can support the production of cellular energy.
 

 
The primary goal of this study will be to assess the effects of creatine monohydrate on the progression of functional decline in HD as measured by the annulazied rate of change in the Total Functional Capacity (TFC) scale. Secondarily, we will aim to examine the long term safety and tolerability of creatine monohydrate and to determine whether its effects correspond to measures of bioavailability, improvement of oxidative injury biomarkers, or reduction of brain atrophy. The design of this study will incorporate interim analyses of safety, futility, and efficacy to provide early and repeated safety data for the FDA at high doses and permit early stopping or modification, if necessary.

Detailed Description

Main entry requirements include: - Age 18 or older - Early (mild to moderate) HD - Able to provide informed consent - Not taking investigational drug - Additional eligibility criteria apply If you are interested in participating in the CREST‐E study you will first have a visit with the study doctor to determine if you are eligible to participate. This visit will include taking a blood sample, as well as other assessments such as evaluation of your general health, movement and mood. During the study you will be assigned randomly to take either active study drug (creatine) or placebo (looks like study drug but has no active ingredients). You will have a series of regularly scheduled visits and telephone calls to evaluate your general health, movement and mood throughout the study. If you think you might want to participate in the CREST‐E study you can contact your local study research team at the University of Utah.

Principal Investigator: David Shprecher
Department: Neurology
Co Investigator: David Shprecher

Contact Information

Name:Paola Wall
Phone: 801-581-4543
Email: paola.wall@hsc.utah.edu

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 ≥ 36.
 
Subjects in Stage I or II of illness (TFC ≥ 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 nonlactating 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 must be capable of providing informed consent and
 
complying with trial procedures.
 
Subjects must be able to take oral drug.

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/day
 
within 30 days of randomization (Baseline visit).
 
Use of supplemental Coenzyme Q10 at a dose greater than 600
 
milligrams daily within 30 days of randomization (Baseline visit).
 
Screening creatinine greater than 2.0 mg/dL.
 
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 randomization (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.