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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Coenzyme Q10

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring Progressive Supranuclear Palsy, Coenzyme Q10

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Neurologische Klinik der Philipps-Universität Marburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Coenzyme Q10

Arm Description

Outcomes

Primary Outcome Measures

Brain Energy Metabolites measured by Magnetic Resonance Spectroscopy

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00328874

First Posted

May 21, 2006

Last Updated

January 7, 2020

Sponsor

German Parkinson Study Group (GPS)

Collaborators

MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany, Pitzer Stiftung, Philipps University Marburg Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00328874

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

German Parkinson Study Group (GPS)

Collaborators

MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany, Pitzer Stiftung, Philipps University Marburg Medical Center

4. Oversight

Data Monitoring Committee

No

5. Study Description

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. akinetic-rigid movement disorder) with prominent postural instability, oculomotor deficits, and cognitive decline (for review: Albers and Augood, 2001; Burn and Lees, 2002). With an average annual incidence of 5.3 per 100000 and an age-adjusted prevalence of 6.4 per 100000, PSP is as common as motor-neuron disease (Burn and Lees, 2002). There is no symptomatic treatment, because PSP patients do not respond to any known therapy (Albers and Augood, 2001; Burn and Lees, 2002). The progression of PSP is rapid and the median survival after onset of symptoms is 5-10 years (Albers and Augood, 2001). Presently, there is no known effective symptomatic or neuroprotective therapy for PSP. 2. Evidence suggests an impairment of mitochondrial energy metabolism in PSP (Albers and Beal, 2002): Reduced cerebral glucose and ATP metabolism have been shown in functional imaging studies in PSP patients (Forster et al., 1988; Martinelli et al., 2000). Cybrid cells harboring mitochondrial genes from PSP patients have decreased ATP-levels and complex I activity (Swerdlow et al., 2000; Albers et al., 2001; Chirichigno et al., 2002). A tropical PSP-like tauopathy has been linked clinically and experimentally to the consumption of the fruit and teas of leaves of the tropical plant annona muricata rich in lipophilic complex I inhibitors (Caparros-Lefebvre et al., 1999; 2001). These clinical observations suggest a role for mitochondrial dysfunction in the etiology of PSP. 3.Coenzyme Q10 (CoQ10) is the physiological electron recipient of complex I. Exogenous CoQ10 (1.) enhances the electron transport by complex I and (2.) powerfully scavenges free radicals. Thus, CoQ10 has been shown to reduce the toxicity of complex I inhibitors in vitro (Menke et al., 2003) and in vivo (Beal et al., 1998

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear Palsy, Coenzyme Q10

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Coenzyme Q10

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Coenzyme Q10

Primary Outcome Measure Information:

Title

Brain Energy Metabolites measured by Magnetic Resonance Spectroscopy

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Oertel, Professor

Organizational Affiliation

Neurologische Klinik der Philipps Universität Marburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neurologische Klinik der Philipps-Universität Marburg

City

Marburg

State/Province

Hessen

ZIP/Postal Code

35033

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.kompetenznetz-parkinson.de

Description

Homepage Competence Network on Parkinson's disease sponsored by the German government, Language German, English

URL

http://www.kks-mr.de

Description

Homepage Coordination Center for Clinical Studies to MEMSA Study, Language: German

Progressive Supranuclear Palsy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial