Coenzyme Q10 in Adult-Onset Ataxia

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborator: University of Florida
• Treatments: Coenzyme Q10; Ubiquinone

Criteria

Inclusion Criteria:

1. Diagnosis of SAOA

2. Age 18 or older

3. Adult onset of ataxia

4. Ambulatory capability (with or without an assisting device)

5. Women with 2 years post menopause or surgical sterility or practicing adequate birth control

6. Stable doses of psychotropic drugs

7. Stable doses of drugs for movement disorders

8. Ability to give informed consent

9. Ability to comply with trial procedures

10. Able to take oral medication

11. No active and significant systemic disease (cardiac, pulmonary, hepatic, renal disease or cancer) that is not under adequate medical control

12. Women with child-bearing potential who have a negative urine pregnancy test and practice adequate contraception during the study

Exclusion Criteria:

1. A history or known sensitivity of intolerability to Coenzyme Q10

2. Diagnosis of secondary (non-degenerative) ataxia

3. Family history of degenerative ataxia

4. Diagnosis of childhood-onset ataxia

5. DNA diagnosis of inherited ataxia in the absence of family history

6. Other investigational agent within 30 days of screening

7. Ingestion of Coenzyme Q10 within 120 days of the baseline visit

8. Diagnosis of ongoing malignancy

9. Women who are pregnant or lactating or who have child bearing potential and not using effective birth control

10. Uncontrolled hypertension

11. Symptomatic orthostatic hypotension

12. Uncontrolled diabetes mellitus

13. Untreated thyroid disease

14. Major psychiatric disease within 12 months of screening

15. History of non-compliance with other therapies

16. Drug or alcohol abuse within 12 months of screening

17. Other condition or therapy that may prevent participation in the opinion of the investigator