NCT00328874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

January 10, 2020

Status Verified

March 1, 2008

First QC Date

May 21, 2006

Last Update Submit

January 7, 2020

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear PalsyCoenzyme Q10

Outcome Measures

Primary Outcomes (1)

  • Brain Energy Metabolites measured by Magnetic Resonance Spectroscopy

Secondary Outcomes (3)

  • 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

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

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Coenzyme Q10

Coenzyme Q10

ACTIVE COMPARATOR
Drug: Coenzyme Q10

Interventions

Coenzyme Q10DRUG
Coenzyme Q10Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurologische Klinik der Philipps-Universität Marburg

Marburg, Hesse, 35033, Germany

Location

Related Links

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wolfgang Oertel, Professor

    Neurologische Klinik der Philipps Universität Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2006

First Posted

May 24, 2006

Study Start

May 1, 2006

Study Completion

February 1, 2007

Last Updated

January 10, 2020

Record last verified: 2008-03

Locations

DE(1)