Coenzyme Q10 in Adult-Onset Ataxia

NCT00957216 | Completed Phase 1

• 2 other identifiers: 08-12908-SAOA-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sporadic Ataxia

Keywords

adult onset ataxia

Outcome Measures

Primary Outcomes (1)

• Measure cerebellar functions by a validated scale (SARA)

  6 weeks

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

Drug: Placebo (sugar pill)

Coenzyme Q10

ACTIVE COMPARATOR

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

Drug: Coenzyme Q10

Interventions

Placebo (sugar pill) DRUG

placebo: 2 wafers 4 times a day

sugar pill

Coenzyme Q10 DRUG

300mg wafers; 2 wafers 4 times a day

Also known as: CoQ10

Coenzyme Q10

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• University of Florida: collaborator

Study Sites (1)

The Universtity of Texas, Galveston

Galveston, Texas, 77555-0539, United States

Location

MeSH Terms

Interventions

Sugars; coenzyme Q10

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Sankarasubramoney H Subramony, MD

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: August 12, 2009
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 11, 2018

Record last verified: 2010-04

Locations

US (1)