Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Study hypothesis:

A 6-week p.o treatment with 5 mg/Kg Coenzyme Q10 is safe and tolerable,increases the brain's metabolism and ameliorates clinical symptoms in patients with PSP.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: German Parkinson Study Group (GPS)
• Collaborators: MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany; Philipps University Marburg Medical Center; Pitzer Stiftung
• Treatments: Coenzyme Q10; Ubiquinone

Criteria

Inclusion Criteria:

• Diagnosis of clinically probable PSP (Litvan et al., 1996).

• Early stage PSP [PSP staging system ≤ III (Golbe, 1997)].

• Capability and willingness to give written informed consent to participate in the study.

Exclusion Criteria:

• Age > 85 years.

• Parkinson syndromes other than PSP (e.g. idiopathic Parkinson's disease, multiple system atrophy, diffuse Lewy body disease, FTDP17, symptomatic parkinsonism)

• Dementia [Mini Mental State Examination (MMSE) ≤ 24]

• History of epilepsy, structural brain disease, brain surgery, or electroconvulsive therapy

• History of stroke related to the onset or progression of PSP symptoms

• Arterial hypertension (systolic >180 or diastolic >110mm Hg)

• Thyroid dysfunction requiring thyroxin supplementation (CoQ10 may change its metabolism)

• Presence of other serious illnesses

• Insufficient contraception in male and pre-menopausal female participants. Accepted means of contraception are hormonal contraception, intrauterine devices, vaginal rings, preservatives, and abstinence.

• Pregnancy or lactation period

• Participation in other drug studies within 60 days before baseline visit.

• Use of CoQ10 within 60 days before baseline visit

• Use of any antioxidants (e.g. vitamin E, C) within 60 days before baseline visit

• Use of any drugs modifying mitochondrial activity within 60 days before baseline visit

• Use of statins within 60 days before baseline visit (inhibit endogenous CoQ10 production)

• Use of drugs interfering with catecholamine metabolism (e.g. reserpine, amphetamines, or monaomine oxidase-A inhibitors, methylphenidate, cinnarizine) within 30 days before baseline visit.

• Use of Levodopa within 30 days before baseline visit (CoQ10 may change its metabolism).

• An unstable dosage of CNS-active drugs (e.g. anxiolytics, hypnotics, tranquillizer, and antidepressants) within 30 days before baseline visit or throughout the study.

• An unstable dosage of other antiparkinsonian drugs within 30 days before baseline visit or throughout the study.