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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00328874
• Date of registration: 21/05/2006
• Prospective Registration: No
• Primary sponsor: German Parkinson Study Group (GPS)
• Public title: Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy
• Scientific title: Mono-center, Prospective, Double-blind, Placebo-controlled, Randomized Clinical Phase IIa Trial to Assess the Safety, Tolerability, and Immediate Biological Effects of Coenzyme Q10 - nanoQuinon® in Progressive Supranuclear Palsy
• Date of first enrolment: May 2006
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00328874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Wolfgang Oertel, Professor
• Affiliation: Neurologische Klinik der Philipps Universität Marburg

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Progressive Supranuclear Palsy

Intervention(s)

Drug: Coenzyme Q10

Primary Outcome(s)

Brain Energy Metabolites measured by Magnetic Resonance Spectroscopy

Secondary Outcome(s)

Evaluation of occuring adverse events(AE), severe adverse events(SAE) up to 6 Weeks after the beginning of the treatment.

Safety and tolerability:Vital signs physical examination and safety laboratory with Blood tests and urine status.

Slowdown of clinical progression after 6 weeks, rated with UPDRS III, PSP rating scale, PSP staging system, modified Hoehn and Yahr, FAB, MMSE, Montgomery- Asberg Depression scale, Schwab and England Score and UPDRS II

Secondary ID(s)

EudraCT: 2005-000574-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany

Pitzer Stiftung

Philipps University Marburg Medical Center