Trial record 1 of 3 for:    coenzyme Q10 and huntington
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Coenzyme Q10 in Huntington's Disease (HD) (2CARE)

This study has been terminated.
(Futility analysis failed to showed likelihoo of benefit of CoQ 2400 mg/day.)
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Information provided by (Responsible Party):
Merit E. Cudkowicz, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00608881
First received: February 4, 2008
Last updated: February 29, 2016
Last verified: February 2016
Results First Received: December 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Huntington's Disease
Interventions: Drug: coenzyme Q10
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A - Coenzyme Q10 2400 mg/Day

Randomized to active treatment (coenzyme Q10 2400 mg/day)

coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day

B - Placebo

Randomized to placebo

placebo: an inactive substance


Participant Flow:   Overall Study
    A - Coenzyme Q10 2400 mg/Day     B - Placebo  
STARTED     303     306  
COMPLETED     224     240  
NOT COMPLETED     79     66  
Death                 22                 13  
Adverse Event                 5                 3  
Lost to Follow-up                 28                 14  
Withdrawal by Subject                 18                 29  
Physician Decision                 5                 5  
Institutionalized                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
A - Coenzyme Q10 2400 mg/Day

Randomized to active treatment (coenzyme Q10 2400 mg/day)

coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day

B - Placebo

Randomized to placebo

placebo: an inactive substance

Total Total of all reporting groups

Baseline Measures
    A - Coenzyme Q10 2400 mg/Day     B - Placebo     Total  
Number of Participants  
[units: participants]
  303     306     609  
Age  
[units: years]
Mean (Standard Deviation)
  50.5  (11.9)     50.7  (11.6)     50.6  (11.7)  
Gender  
[units: participants]
     
Female     149     164     313  
Male     154     142     296  



  Outcome Measures
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1.  Primary:   Joint Rank (Combination of Time to Death (for Subjects Who Died) and Change in Total Functional Capacity Score (TFC) From Baseline to Month 60 (for Subjects Who Survived))   [ Time Frame: 5 years ]

2.  Secondary:   Change in Total Functional Capacity (TFC) Score From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

3.  Secondary:   Change in Functional Checklist Score From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

4.  Secondary:   Change in Independence Scale Score From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

5.  Secondary:   Change in Total Motor Score From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

6.  Secondary:   Change in Behavioral Frequency Score From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

7.  Secondary:   Change in Behavioral Frequency x Severity Score From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

8.  Secondary:   Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

9.  Secondary:   Change in Verbal Fluency Test From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

10.  Secondary:   Change in Stroop Interference Test - Color Naming From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

11.  Secondary:   Change in Stroop Interference Test - Word Reading From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

12.  Secondary:   Change in Stroop Interference Test - Interference From Baseline to Month 60   [ Time Frame: Baseline and Month 60 ]

13.  Secondary:   Time to a Two-Point Decline in TFC Score or Death   [ Time Frame: 5 years ]

14.  Secondary:   Time to a Three-Point Decline in TFC Score or Death   [ Time Frame: 5 years ]

15.  Secondary:   Number Completing Study at Assigned Dosage Level   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
An interim analysis for futility revealed a conditional power of < 5% for the primary analysis, and the trial was halted in July, 2014. Only data collected prior to this time were included in the final analyses.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Merit Cudkowicz
Organization: Massachusetts General Hospital
phone: 617-726-0813
e-mail: mcudkowicz@partners.org


Publications:
Kowall N, Ferrante R, Martin J. Patterns of cell loss in Huntington's disease. Trends in Neurosciences 1987;10:24-29.
Riley D, Lang A. Movement Disorders. In: Bradley W, Daroff R, Fenichel G, eds. Neurology in Clinical Practice. The Neurological Disorders. Boston: Butterworth-Heinemann, 1991: 1563-1601.
Bruyn G. Huntington's chorea: Historical clinical and laboratory synopsis. In: Vinken P, Bruyn G, eds. Handbook of Clinical Neurology. Amsterdam, 1968: 298-378.
Greenamyre J, Shoulson I. Huntington's Disease. In: Calne D, ed. Neurodegenerative Diseases. Philadelphia: WB Saunders, 1994: 685-704.
Kido D, Shoulson I, Manzione J, Harnish P. Measurement of caudate nucleus and putamen atrophy in patients with Huntington's disease. Neuroradiology 1991;33:604-606.
Yamagami T, Okishio T, Toyama S, Kishi T. Correlation of serum coenzyme Q10 level and leukocute complex II activity in nformal and cardiovascular patients. In: Folkers K, Yamagami T, eds. Biomedical and clinical aspects of coenzyme Q: Elsevier Science Publishers, 1981: 79-89.
Dubois B, Brand M, Garcia de Yebenes J, et al. European-Huntington's-disease-Initiative (EHDI)-Trial: Objectives, design, and description of the study population at the end of inclusion. Mov Dis 2002;17:S319.
Bogentoft C, Edelund P, Olsson B, Widlund L, Westensen K. Biopharmaceutical aspects of intraveneous and oral administration of coenzyme Q10. In: Folkers K, Littarru G, Yamagami T, eds. Biomedical and clinical aspects of coenzyme Q.: Elsevier Science Publishers, 1991: 215-224.
Lucker P, Wetselsberg N, Hennings G, Rehn D. Pharmacokinetics of coenzyme ubidecarenone in healthy volunteers. In: Folkers K, Littarru G, Yamagami T, eds. Biomedical and clinical aspects of coenzyme Q: Elsevier Science Publishers, 1984: 143-151.
Micromedex. Ubidecarenone drug monograph. Engelwood 1995 May; Update 1998 Mar.
Weber C. Dietary intake and absorption of coenzyme Q. In: Kagan V, Quinn P, eds. Coenzyme Q: Molecular Mechanisms in Health and Disease. Boca Raton: CRC Press, 2001:209-215.
Saito Y, Kubo H, Bujo H, Yamamoto Y. The changes in plasma coenzyme Q10 level during the statin therapy for hypercholesterolemic patients. In: Second Conference of the International Coenzyme Q10 Association.; 2000, 2000: 59.


Responsible Party: Merit E. Cudkowicz, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00608881     History of Changes
Other Study ID Numbers: 2CARE 01.00
5U01NS052592 ( US NIH Grant/Contract Award Number )
5R01NS052619 ( US NIH Grant/Contract Award Number )
Study First Received: February 4, 2008
Results First Received: December 7, 2015
Last Updated: February 29, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada