Coenzyme Q10 in Adult-Onset Ataxia

Completed · Phase 1 · Has a placebo group

Conditions studied: Sporadic Ataxia

In brief

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.

Key facts

Study ID

NCT00957216

Run by

The University of Texas Medical Branch, Galveston

People needed

1

Starts

2008-04-01

Expected to finish

2009-08-01

Last updated by the study team

2018-07-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Universtity of Texas, Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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