NCT00026988

Brief Summary

This study, CREST-HD, will examine the safety and tolerability of 8 grams of creatine in subjects affected by Huntington's disease (HD). Biochemistry and neuroimaging will be used to examine the potential effects of creatine on HD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2001

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

August 18, 2006

Status Verified

July 1, 2006

First QC Date

November 15, 2001

Last Update Submit

August 17, 2006

Conditions

Huntington's Disease

Keywords

Huntington's diseasecreatineenergy depletion

Interventions

CreatineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Diagnosis of HD confirmed by known family history or by CAG repeat expansion \>37. * Clinical stage I or II as determined by a functional capacity scale \>7; must have evident motor signs * Men and women \>18 years if age with a clinical diagnosis of HD. Women of childbearing age may participate if they have a negative pregnancy test at screening and are either using adequate birth control, post menopausal, or are surgically sterile. * Stable doses of any psychotropic medications for 4 weeks prior to randomization and should be maintained on constant dosage throughout the course of the trial. * Capable of providing informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Steven Hersch, M.D., Ph.D.

Boston, Massachusetts, 02129, United States

Location

Andrew Feigin, M.D.

Long Island City, New York, United States

Location

Karen Marder, M.D.

New York, New York, 10032, United States

Location

Peter Como, Ph.D.

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Huntington Disease

Interventions

Creatine

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Steven Hersch, MD

    Harvard School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 15, 2001

First Posted

November 16, 2001

Study Start

October 1, 2001

Study Completion

June 1, 2006

Last Updated

August 18, 2006

Record last verified: 2006-07

Locations

US(4)