Status:
COMPLETED
Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy
Lead Sponsor:
German Parkinson Study Group (GPS)
Collaborating Sponsors:
MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany
Pitzer Stiftung
Conditions:
Progressive Supranuclear Palsy
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief 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.
Detailed Description
Background and Rationale: 1\. Progressive Supranuclear Palsy (PSP, Steele-Richardson-Olszewski Syndrome) is a sporadic neurodegenerative disorder resulting clinically in a Parkinson syndrome (i.e. ak...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00328874
Start Date
May 1 2006
End Date
February 1 2007
Last Update
January 10 2020
Active Locations (1)
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1
Neurologische Klinik der Philipps-Universität Marburg
Marburg, Hesse, Germany, 35033