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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
University of Rochester
Information provided by (Responsible Party):
Steven M. Hersch, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00712426
First received: July 8, 2008
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available.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 is studied. A variety of biological processes are assessed for markers of disease activity or progression and creatine effects. Up to 50 active research centers globally will enroll 650 subjects.


Condition Intervention Phase
Huntington's Disease
Drug: Creatine Monohydrate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Total Functional Capacity [ Time Frame: Minimum 12 months up to 48 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: Duration of the trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 650
Study Start Date: September 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: Placebo
Up to 40 grams daily, powder form placebo (inactive substance), taken for the trial duration
Other Name: Dextrose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712426

Contacts
Contact: Huntington Study Group 1-800-487-7671

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jenna Smith, RN, BSN    205-996-2807    jennat@uab.edu   
Principal Investigator: Victor Sung, MD, PhD         
Sub-Investigator: David Standaert, MD, PhD         
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Shari Niswonger, RN    949-824-8116    slniswon@uci.edu   
Principal Investigator: Neal Hermanowicz, MD         
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Amanda Martin    916-734-3541    amanda.martin@ucdmc.ucdavis.edu   
Principal Investigator: Vicki L Wheelock, MD         
Sub-Investigator: Lin Zhang, MD, PhD         
United States, Colorado
Colorado Neurological Institute Withdrawn
Engelwood, Colorado, United States, 80113
United States, Connecticut
University of Connecticut Recruiting
Farmington, Connecticut, United States, 06030
Contact: Bonnie Hennig    860-679-4063    hennig@uchc.edu   
Principal Investigator: Carolyn Drazinic, MD         
United States, Florida
University of Florida (McKnight Brain Institute) Recruiting
Gainesville, Florida, United States, 32610
Contact: Camille Schwartz, BA    352-273-5612    cami.swartz@neurology.ufl.edu   
Principal Investigator: Ramon Rodriguez, MD         
Sub-Investigator: Tetsuo Ashizawa, MD         
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Kelly Elliott, RN    813-974-6022    kelliot@health.usf.edu   
Principal Investigator: Juan Sanchez-Ramos, MD, PhD         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30329
Contact: Elaine Sperin, LPN    404-728-4786    esperin@emory.edu   
Principal Investigator: Randi Jones, PhD         
Sub-Investigator: Stewart A. Factor, DO         
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30329
Contact: Paula Jackson, BA    706-721-4152    paujackson@gru.edu   
Principal Investigator: John C. Morgan, MD, PhD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Jeana Jaglin, RN    312-942-5003    jjaglin2@rush.edu   
Principal Investigator: Kathleen M Shannon, MD         
University of Chicago Withdrawn
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 27157
Contact: Andrea Hurt, LPN    317-963-7449    andhurt@iupui.edu   
Principal Investigator: Elizabeth Zauber, MD         
Sub-Investigator: Joanne Wojcieszek, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jacky Walker    319-353-4537    jacky-walker@uiowa.edu   
Principal Investigator: Eric Epping, MD, PhD         
United States, Kansas
University of Kansas Medical Center Active, not recruiting
Kansas City, Kansas, United States, 66160
Hereditary Neurological Disease Center (HNDC) Recruiting
Wichita, Kansas, United States, 67206
Contact: Greg Suter, BA    316-609-3020    hndcentre@aol.com   
Principal Investigator: William Mallonee, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Annette Robinson, RN, BSN    502-540-3585    annette.robinson@louisville.edu   
Principal Investigator: Kathrin LaFaver, MD         
Sub-Investigator: Walter Olson, Jr., MD         
United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: Samantha Gibson    410-328-4349    sagibson@som.umaryland.edu   
Principal Investigator: Christian Lachner, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Sue Imbriglio    617-726-0894    simbriglio@partners.org   
Principal Investigator: Diana Rosas, MD, MS         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Elizabeth Sullivan, BGS    734-232-6247    elizsull@umich.edu   
Principal Investigator: Praveen Dayalu, MD         
Sub-Investigator: Kelvin Chou, MD         
United States, Minnesota
Struthers Parkinson's Center Recruiting
Golden Valley, Minnesota, United States, 55427
Contact: Kathyrn Duderstadt    952-993-5903    kathryn.duderstadt@parknicollet.com   
Principal Investigator: Martha Nance, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Patricia Deppen, RN    314-362-8548    deppenp@neuro.wustl.edu   
Principal Investigator: Brad A. Racette, MD         
Sub-Investigator: Susan Criswell, MD         
United States, Nebraska
Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Carolyn Peterson, RN    402-552-2239    cpeterson@nebraskamed.com   
Principal Investigator: Diego Torres-Russotto, MD         
Sub-Investigator: Amy Hellman, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Cory Hackmyer    856-342-2460    hackmyer-cory@cooperhealth.edu   
Principal Investigator: Amy Colcher, MD         
Sub-Investigator: Andrew McGarry         
NJ Neuroscience Institute, JFK Medical Center Withdrawn
Edison, New Jersey, United States, 08818
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Sharon Evans    518-262-6682    evanss@mail.amc.edu   
Principal Investigator: Adolfo Ramirez-Zamora, MD         
North Shore-LIJ Health System Recruiting
Manhasset, New York, United States, 11030
Contact: Barbara Shannon, RN    516-562-2905    bshannon@nshs.edu   
Principal Investigator: Andrew Feigin, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Carol Moskowitz, ANP, MS    212-305-5779    cbm4@columbia.edu   
Principal Investigator: Karen Marder, MD         
University of Rochester Recruiting
Rochester, New York, United States, 14618
Contact: Ashley Owens    585-341-7593    ashley_owens@urmc.rochester.edu   
Principal Investigator: Kevin Biglan, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Peggy Perry-Trice    919-684-0865    peggy.perrytrice@duke.edu   
Principal Investigator: Burton Scott, MD         
Sub-Investigator: Mark Stacy, MD         
Wake Forest University School of Medicine Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Christine O'Neill    336-716-8611    coneill@wfubmc.edu   
Principal Investigator: Francis Walker, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Hilary Perez, PhD    513-558-0112    hilary.perez@uc.edu   
Principal Investigator: Fredy Revilla, MD         
Sub-Investigator: Andrew Duker, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jennifer Mule    216-444-1134    mulej@ccf.org   
Principal Investigator: Anwar Ahmed, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Allison Daley, MS    614-688-8672    allison.daley@osumc.edu   
Principal Investigator: Sandra Kostyk, MD, PhD         
United States, Pennsylvania
University of Pennsylvania Completed
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Larry Ivanco    412-692-2394    lsi1@pitt.edu   
Principal Investigator: Valerie Suski, DO         
Sub-Investigator: Timothy Greenamyer, MD, PhD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Amy Jo Delambo, NP    843-792-5543    delambo@musc.edu   
Principal Investigator: Gonzalo Revuelta, DO         
United States, Tennessee
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38163
Contact: Misty Thompson, PhD    901-448-7375    mthomp82@uthsc.edu   
Principal Investigator: Mark S LeDoux, MD         
United States, Texas
University of Texas Medical Branch at Galveston Withdrawn
Galveston, Texas, United States, 77555
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Paola Wall    801-581-4543    paola.wall@hsc.utah.edu   
Principal Investigator: David Shprechner, DO         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Susan Dietrich    434-243-5422    sjd3c@virginia.edu   
Principal Investigator: Madaline Harrison, MD         
Sub-Investigator: Frederick Wooten, MD         
United States, Washington
Booth Gardner Parkinson's Care Center (Evergreen Healthcare) Recruiting
Kirkland, Washington, United States, 98034
Contact: Marsha Merrick    425-899-3115    mgmerrick@evergreenhealthcare.org   
Principal Investigator: Pinky Agarwal, MD         
Australia, New South Wales
Westmead Hospital Recruiting
Wentworthville, New South Wales, Australia, 2145
Contact: Jane Griffith    +61-2-9845-9139    jane.griffith@health.nsw.gov.au   
Sub-Investigator: Elizabeth McCusker, MD         
Principal Investigator: Clement Loy, MD         
Australia, Western Australia
Neurodegenerative Disorders Research Recruiting
Subiaco, Western Australia, Australia, 6008
Contact: Nicola Lewis    618-9481-6293    bestactor@bigpond.com   
Principal Investigator: Peter Panegyres, MBBS, PhD         
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T2N 4Z6
Contact: Paul McCann    (780) 407-1614    paul.mccann@albertahealthservices.ca   
Principal Investigator: Oksana Suchowersky, MD         
University of Alberta Recruiting
Edmonton, Alberta, Canada, T2N 4Z6
Contact: Pam King    780−407−5439    Pam.King@albertahealthservices.ca   
Principal Investigator: Wayne Martin, MD         
Sub-Investigator: Marguerite Wieler, MSc         
Canada, Manitoba
Movement Disorder Clinic Deer Lodge Center Recruiting
Winnipeg, Manitoba, Canada, R3J 2H7
Contact: Shaun Hobson, RN    204-940-8400    shobson@mdc-dlc.ca   
Principal Investigator: Doug Hobson, MD         
Canada, Ontario
London Health Sciences Center Withdrawn
London, Ontario, Canada, N6A 5A5
North York General Hospital Withdrawn
Toronto, Ontario, Canada, M2K 1E1
Canada, Quebec
CHUM - Hopital Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Benoit Gagnon    514-890-8000 ext 26519    benoit.gagnon.chum@ssss.gouv.qc.ca   
Principal Investigator: Sylvain Chouinard, MD         
Sub-Investigator: Michel Panisset, MD         
University of Quebec Infant-Jesus Hospital (Centre Hospitalier Affilie) Recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Contact: Caroline Tremblay, RN    418-649-0252 ext 3243    tremblay.caroline@crhdq.chuq.qc.ca   
Principal Investigator: Melanie Langlois, MD         
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1142
Contact: Virginia Hogg, MA    +64-9-367-0000    vhogg@adhb.govt.nz   
Principal Investigator: Richard Roxburgh, BSC MB, PhD         
New Zealand Brain Research Institute Recruiting
Christchurch, New Zealand, 8011
Contact: Laura Paermentier    +64-3-378-6662    laurap@cdhb.govt.nz   
Principal Investigator: Tim Anderson, MBChB, MD         
Sponsors and Collaborators
Massachusetts General Hospital
University of Rochester
Investigators
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
  More Information

Additional Information:
Publications:

Responsible Party: Steven M. Hersch, Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00712426     History of Changes
Other Study ID Numbers: 2007P000827, U01AT000613
Study First Received: July 8, 2008
Last Updated: May 13, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
New Zealand: Food Safety Authority
New Zealand: Health Research Council
New Zealand: Health and Disability Ethics Committees
New Zealand: Institutional Review Board
New Zealand: Medsafe

Keywords provided by Massachusetts General Hospital:
Huntington's disease
Creatine
Mitochondrial Dysfunction
Total Functional Capacity
UHDRS

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias

ClinicalTrials.gov processed this record on July 23, 2014