- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00957216
Coenzyme Q10 in Adult-Onset Ataxia (CoQATAX)
Safety and Tolerability of Coenzyme Q10 in Adult-Onset Sporadic Spinocerebellar Ataxia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Physician-sponsored pilot study, whose purpose it is determine if high-dose oral Coenzyme Q10 (CoQ10) is safe and tolerated in patients with sporadic forms of adult-onset spinocerebellar ataxias (SAOA), a group of degenerative neurological disorders affecting the cerebellum and pathways to and from the cerebellum, with or without additional central nervous system (CNS) manifestations, in the absence of family history of degenerative ataxias.
CoQ10 is an essential cofactor of the electron transport chain and is a potent free radical scavenger in lipid and mitochondrial membranes. CoQ10 has shown efficacy in treatment of Parkinson's disease patients, and a Huntington's disease trial gave a trend of slowing down disease progression (CARE-HD). A small trial of CoQ10 in patients with Friedreich's ataxia suggested potential beneficial effects on ventricular thickness. CoQ10 is being tested on ALS patients and is considered to be potentially useful for treatment of Alzheimer's disease. Thus, CoQ10 is considered to be a promising therapeutic agent that might slow down the disease progression in a wide variety of neurodegenerative disorders. To date, very high doses of CoQ10 have not been used in patients with ataxia and the safety and tolerability in this group of patients should be established before efficacy trials are launched.
Twenty patients with SAOA will be recruited for a double-blind, randomized, placebo-controlled, multicenter study. Fifteen patients will receive a total of 2400 mg of oral CoQ10 daily, and five patients will receive placebo, for a period or 4 weeks. Cerebellar functions will be measured using a validated rating scale (SARA), an oculomotor examination, and functional measurement of motor function using a 9 hole peg test and timed walk. Safety labs will be collected and a digital movie will be recorded at the beginning (prior to treatment with CoQ10) and at the end of the study.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Galveston, Texas, United States, 77555-0539
- The Universtity of Texas, Galveston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of SAOA
- Age 18 or older
- Adult onset of ataxia
- Ambulatory capability (with or without an assisting device)
- Women with 2 years post menopause or surgical sterility or practicing adequate birth control
- Stable doses of psychotropic drugs
- Stable doses of drugs for movement disorders
- Ability to give informed consent
- Ability to comply with trial procedures
- Able to take oral medication
- No active and significant systemic disease (cardiac, pulmonary, hepatic, renal disease or cancer) that is not under adequate medical control
- Women with child-bearing potential who have a negative urine pregnancy test and practice adequate contraception during the study
Exclusion Criteria:
- A history or known sensitivity of intolerability to Coenzyme Q10
- Diagnosis of secondary (non-degenerative) ataxia
- Family history of degenerative ataxia
- Diagnosis of childhood-onset ataxia
- DNA diagnosis of inherited ataxia in the absence of family history
- Other investigational agent within 30 days of screening
- Ingestion of Coenzyme Q10 within 120 days of the baseline visit
- Diagnosis of ongoing malignancy
- Women who are pregnant or lactating or who have child bearing potential and not using effective birth control
- Uncontrolled hypertension
- Symptomatic orthostatic hypotension
- Uncontrolled diabetes mellitus
- Untreated thyroid disease
- Major psychiatric disease within 12 months of screening
- History of non-compliance with other therapies
- Drug or alcohol abuse within 12 months of screening
- Other condition or therapy that may prevent participation in the opinion of the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: sugar pill
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placebo: 2 wafers 4 times a day
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Active Comparator: Coenzyme Q10
The CoQ10 arm will be compared with the placebo arm to determine if high-dose CoQ10 is safe and well tolerated in subjects with sporadic adult-onset spinocerebellar ataxias
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300mg wafers; 2 wafers 4 times a day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure cerebellar functions by a validated scale (SARA)
Time Frame: 6 weeks
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6 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sankarasubramoney H Subramony, MD, University of Texas medical branch, Galveston
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-129
- 08-SAOA-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sporadic Ataxia
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Ataxia Study GroupGerman Center for Neurodegenerative Diseases (DZNE)RecruitingLate Onset Sporadic Cerebellar AtaxiaNorway, Austria, Germany, Netherlands, Italy
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Cadent TherapeuticsWithdrawnSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8 | Spinocerebellar Ataxia Type 17 | ARCA1 - Autosomal Recessive...United States
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Novartis PharmaceuticalsCompletedSporadic Inclusion Body Myositis (sIBM)United States
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Biohaven Pharmaceuticals, Inc.Active, not recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8United States, China
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Assistance Publique - Hôpitaux de ParisCompletedSpinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia, Autosomal Recessive 3 | Episodic Ataxia, Type 7France
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University of ChicagoPfizer; Biogen; APDM Wearable TechnologiesActive, not recruitingSpinocerebellar Ataxia Type 3 | Friedreich Ataxia | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6United States
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Biohaven Pharmaceuticals, Inc.Active, not recruitingSpinocerebellar Ataxias | Spinocerebellar Ataxia Genotype Type 1 | Spinocerebellar Ataxia Genotype Type 2 | Spinocerebellar Ataxia Genotype Type 3 | Spinocerebellar Ataxia Genotype Type 6 | Spinocerebellar Ataxia Genotype Type 7 | Spinocerebellar Ataxia Genotype Type 8 | Spinocerebellar Ataxia Genotype...United States
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Sclnow Biotechnology Co., Ltd.Not yet recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6
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