Status:
COMPLETED
Coenzyme Q10 in Adult-Onset Ataxia
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
University of Florida
Conditions:
Sporadic Ataxia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 ata...
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 ata...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00957216
Start Date
April 1 2008
End Date
August 1 2009
Last Update
July 11 2018
Active Locations (1)
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1
The Universtity of Texas, Galveston
Galveston, Texas, United States, 77555-0539