NCT01412151

Brief Summary

The purpose of this study is to extend findings from the creatine dose-finding study (CREST-UP1) in Huntington's disease to evaluate the long-term safety, tolerability, and clinical impact of high dose creatine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 28, 2012

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

6.6 years

First QC Date

August 5, 2011

Results QC Date

November 28, 2012

Last Update Submit

February 6, 2018

Conditions

Huntington's Disease (HD)

Keywords

SymptomaticHuntington's DiseaseHD

Outcome Measures

Primary Outcomes (1)

  • Tolerability

    Proportion of subjects able to complete treatment

    306 Weeks

Secondary Outcomes (2)

  • Clinical Measures Resources Not Available to Complete Secondary Analyses.

    310 Weeks

  • Biological Markers of Disease Progression

    310 Weeks

Study Arms (1)

Creatine monohydrate

OTHER

single arm long-term open label follow-up

Drug: Creatine monohydrate

Interventions

Creatine monohydrateDRUG

Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose

Also known as: creatine, crea-pure
Creatine monohydrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who have completed the CREST-UP1 study.
  • Individuals who are able to take oral medication.
  • Individuals capable of providing informed consent and complying with trial procedures.

You may not qualify if:

  • History of known sensitivity or intolerability to creatine.
  • Clinical evidence of unstable medical illness in the investigator's judgment.
  • Additional eligibility criteria apply.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (10)

  • Hersch SM, Gevorkian S, Marder K, Moskowitz C, Feigin A, Cox M, Como P, Zimmerman C, Lin M, Zhang L, Ulug AM, Beal MF, Matson W, Bogdanov M, Ebbel E, Zaleta A, Kaneko Y, Jenkins B, Hevelone N, Zhang H, Yu H, Schoenfeld D, Ferrante R, Rosas HD. Creatine in Huntington disease is safe, tolerable, bioavailable in brain and reduces serum 8OH2'dG. Neurology. 2006 Jan 24;66(2):250-2. doi: 10.1212/01.wnl.0000194318.74946.b6.

    PMID: 16434666BACKGROUND

  • Kim J, Amante DJ, Moody JP, Edgerly CK, Bordiuk OL, Smith K, Matson SA, Matson WR, Scherzer CR, Rosas HD, Hersch SM, Ferrante RJ. Reduced creatine kinase as a central and peripheral biomarker in Huntington's disease. Biochim Biophys Acta. 2010 Jul-Aug;1802(7-8):673-81. doi: 10.1016/j.bbadis.2010.05.001. Epub 2010 May 9.

    PMID: 20460152BACKGROUND

  • Rosas HD, Salat DH, Lee SY, Zaleta AK, Pappu V, Fischl B, Greve D, Hevelone N, Hersch SM. Cerebral cortex and the clinical expression of Huntington's disease: complexity and heterogeneity. Brain. 2008 Apr;131(Pt 4):1057-68. doi: 10.1093/brain/awn025. Epub 2008 Mar 12.

    PMID: 18337273BACKGROUND

  • Dedeoglu A, Kubilus JK, Yang L, Ferrante KL, Hersch SM, Beal MF, Ferrante RJ. Creatine therapy provides neuroprotection after onset of clinical symptoms in Huntington's disease transgenic mice. J Neurochem. 2003 Jun;85(6):1359-67. doi: 10.1046/j.1471-4159.2003.01706.x.

    PMID: 12787055BACKGROUND

  • Stack EC, Dedeoglu A, Smith KM, Cormier K, Kubilus JK, Bogdanov M, Matson WR, Yang L, Jenkins BG, Luthi-Carter R, Kowall NW, Hersch SM, Beal MF, Ferrante RJ. Neuroprotective effects of synaptic modulation in Huntington's disease R6/2 mice. J Neurosci. 2007 Nov 21;27(47):12908-15. doi: 10.1523/JNEUROSCI.4318-07.2007.

    PMID: 18032664BACKGROUND

  • Hersch SM, Rosas HD. Neuroprotective therapy for Huntington's disease: new prospects and challenges. Expert Rev Neurother. 2001 Sep;1(1):111-8. doi: 10.1586/14737175.1.1.111.

    PMID: 19811052BACKGROUND

  • Borovecki F, Lovrecic L, Zhou J, Jeong H, Then F, Rosas HD, Hersch SM, Hogarth P, Bouzou B, Jensen RV, Krainc D. Genome-wide expression profiling of human blood reveals biomarkers for Huntington's disease. Proc Natl Acad Sci U S A. 2005 Aug 2;102(31):11023-8. doi: 10.1073/pnas.0504921102. Epub 2005 Jul 25.

    PMID: 16043692BACKGROUND

  • Ryu H, Rosas HD, Hersch SM, Ferrante RJ. The therapeutic role of creatine in Huntington's disease. Pharmacol Ther. 2005 Nov;108(2):193-207. doi: 10.1016/j.pharmthera.2005.04.008. Epub 2005 Aug 1.

    PMID: 16055197BACKGROUND

  • Hersch SM, Rosas HD. Neuroprotection for Huntington's disease: ready, set, slow. Neurotherapeutics. 2008 Apr;5(2):226-36. doi: 10.1016/j.nurt.2008.01.003.

    PMID: 18394565BACKGROUND

  • Rosas HD, Salat DH, Lee SY, Zaleta AK, Hevelone N, Hersch SM. Complexity and heterogeneity: what drives the ever-changing brain in Huntington's disease? Ann N Y Acad Sci. 2008 Dec;1147:196-205. doi: 10.1196/annals.1427.034.

    PMID: 19076442BACKGROUND

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

Limitations and Caveats

secondary analyses no completed

Results Point of Contact

Title
Steven M. Hersch, MD, PhD
Organization
Massachusetts General Hospital
hersch@helix.mgh.harvard.edu
617-726-1254

Study Officials

  • Diana Rosas, MD, MS

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Steven M Hersch, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 9, 2011

Study Start

April 1, 2005

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

March 9, 2018

Results First Posted

December 28, 2012

Record last verified: 2018-02

Locations

US(1)