Progressive Supranuclear PalsyPhase 2NCT00328874
Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy
A Phase 2 study testing Coenzyme Q10 in people with Progressive Supranuclear Palsy, run by German Parkinson Study Group (GPS) at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2006to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Neurologische Klinik der Philipps-Universität Marburg
Marburg, Hesse, 35033
About this study
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 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.
Read the detailed description
Background and Rationale:
- 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.
- 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
- Conditions
- Progressive Supranuclear Palsy
- Being tested
- Coenzyme Q10
- Keywords
- Progressive Supranuclear Palsy, Coenzyme Q10
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Coenzyme Q10 |
| Coenzyme Q10 | Active comparator | Not described Receives: Drug: Coenzyme Q10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startMay 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Parkinson Study Group (GPS)
- Sponsor type
- University, hospital or other
- Collaborators
- MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany, Pitzer Stiftung, Philipps University Marburg
- Investigators
- Wolfgang Oertel, Professor, Principal investigator, Neurologische Klinik der Philipps Universität Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328874
- Sponsor's protocol ID
- EudraCT: 2005-000574-40
- Status last verified
- Mar 2008
- First submitted
- 21 May 2006
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00328874
- Acronym / sponsor ID
- EudraCT: 2005-000574-40
- Conditions
- Progressive Supranuclear Palsy
- Keywords
- Progressive Supranuclear Palsy, Coenzyme Q10
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- German Parkinson Study Group (GPS)University, hospital or other
- Collaborators
- MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany, Pitzer Stiftung, Philipps University Marburg
- Study start
- May 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 24 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Coenzyme Q10 |
| Coenzyme Q10 | Active comparator | Drug: Coenzyme Q10 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10 | Drug | Coenzyme Q10, Placebo |
Primary outcome
Brain Energy Metabolites measured by Magnetic Resonance Spectroscopy
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Homepage Competence Network on Parkinson's disease sponsored by the German government, Language German, EnglishLink provided by the sponsor.
- Homepage Coordination Center for Clinical Studies to MEMSA Study, Language: GermanLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Oertel, Professor principal investigator
Neurologische Klinik der Philipps Universität Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coenzyme Q10 in people with Progressive Supranuclear Palsy, run by German Parkinson Study Group (GPS) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Energy Metabolites measured by Magnetic Resonance Spectroscopy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.