Parkinson's DiseasePhase 3NCT00180037
Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease
A Phase 3 study testing Coenzyme Q10 Nanodispersion (Nanoquinone) in people with Parkinson's Disease, run by Technische Universität Dresden at 13 sites in Germany.
Trial summary
This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage Parkinson's disease (PD) patients (Hoehn\&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Coenzyme Q10 Nanodispersion (Nanoquinone)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 13 sitesGermany
- Study dates
- Sep 2003to Jun 2005
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease according to the UK Brain Bank criteria
- Hoehn \& Yahr stadium II until III
- Male or female
- Age 40 to 75 years
- UPDRS Part III > 15 points
- No motor fluctuations or dyskinesias
Show all 10Show fewer
- Stable parkinsonian condition for 4 weeks prior to inclusion
- Outpatients
- Patients without or with stable levodopa treatment for 4 weeks prior inclusion
- Written informed consent
Who cannot join
- Atypical or drug-induced parkinsonian syndromes
- Dyskinesias or motor fluctuations
- Coenzyme Q10 treatment in the past
- Pregnancy
- Epileptic seizures in the history
- Hypothyroidism
Show all 9Show fewer
- Severe medical conditions with interference with study drug
- Treatment with CSE inhibitors, thyroidal hormones, antiarrhythmic drugs, warfarin, metformin
- Treatment or intake of vitamins, magnesium, vitamin E, calcium
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Department of Neurology, Charite Berlin
Berlin, State of Berlin, 13353
Department of Neurology, Ruhr-University of Bochum
Bochum, North Rhine-Westphalia, 44791
Department of Neurology, Technical University of Dresden
Dresden, Saxony, 01307
Department of Neurology, Klinikum Essen-Borbeck
Essen, North Rhine-Westphalia, 45359
Department of Neurology, Klinik Ambrock
Hagen, North Rhine-Westphalia, 58091
Department of Neurology, University of Homburg
Homburg, Saarland, 66421
Department of Neurology, Fachklinik Ichenhausen
Ichenhausen, Bavaria, 89335
Department of Nuerology, Klinikum Lippe
Lemgo, Lower Saxony, 32657
Department of Neurology, Klinikum Lueneburg
Lüneburg, Lower Saxony, 21339
Department of Neurology, University of Marburg
Marburg, Hesse, 35039
Department of Neurology, Leopoldina Krankenhaus
Schweinfurt, Bavaria, 97422
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, 89081
Department of Neurology, Deutsche Klinik fuer Diagnostik
Wiesbaden, Hesse, 65191
About this study
Official title: Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease
This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage Parkinson's disease (PD) patients (Hoehn\&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo.
The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III.
The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in PD patients.
Read the detailed description
This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage non-fluctuating Parkinson's disease (PD) patients (Hoehn\&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo.
The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes 100 mg Coenzyme Q10 nanodispersion (Nanoquinon solution) tid or matched placebo for three months.
Participating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients.
The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III.
The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in PD patients.
Main inclusion criteria:
- Parkinson's disease according to the UK Brain Bank criteria
- Hoehn \& Yahr stadium II until III
- Age 40 to 75 years
- UPDRS Part III > 15 points
- No motor fluctuations or dyskinesias
- Stable medication for 4 weeks prior to inclusion
Main exclusion criteria:
- Atypical parkinsonian syndromes
- Dyskinesias or motor fluctuations
- Coenzyme Q10 treatment in the past
- Pregnancy
- Conditions
- Parkinson's Disease
- Being tested
- Coenzyme Q10 Nanodispersion (Nanoquinone), Placebo
- Keywords
- Parkinson's disease, Coenzyme Q10, Treatment, Neuroprotection
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10 Nanodispersion (Nanoquinone)Drug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
Secondary outcomes (10)
Total UPDRS
Safety
PDQ-39
SF36
CGI
Schwab&England
Montgomery-Asperg
Pain
Incontinence
Sexual behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 132 participants
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Parkinson-Vereinigung e.V., MSE Pharmazeutika GmbH, Bad Homburg
- Investigators
- Heinz Reichmann, MD, Principal investigator, Technical University of Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180037
- Sponsor's protocol ID
- 78052003
- Status last verified
- Jan 2009
- First submitted
- 9 Sep 2005
- Last updated
- 19 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Storch A, Jost WH, Vieregge P, Spiegel J, Greulich W, Durner J, Muller T, Kupsch A, Henningsen H, Oertel WH, Fuchs G, Kuhn W, Niklowitz P, Koch R, Herting B, Reichmann H; German Coenzyme Q(10) Study Group. Randomized, double-blind, placebo-controlled trial on symptomatic effects of coenzyme Q(10) in Parkinson disease. Arch Neurol. 2007 Jul;64(7):938-44. doi: 10.1001/archneur.64.7.nct60005. Epub 2007 May 14.
PubMed 17502459
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00180037
- Acronym / sponsor ID
- 78052003
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Coenzyme Q10, Treatment, Neuroprotection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Deutsche Parkinson-Vereinigung e.V., MSE Pharmazeutika GmbH, Bad Homburg
- Study start
- Sep 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 16 Sep 2005 (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.
This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage Parkinson's disease (PD) patients (Hoehn\&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo.
The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III.
The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in PD patients.
Detailed description
This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage non-fluctuating Parkinson's disease (PD) patients (Hoehn\&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo.
The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes 100 mg Coenzyme Q10 nanodispersion (Nanoquinon solution) tid or matched placebo for three months.
Participating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients.
The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III.
The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in PD patients.
Main inclusion criteria:
- Parkinson's disease according to the UK Brain Bank criteria
- Hoehn \& Yahr stadium II until III
- Age 40 to 75 years
- UPDRS Part III > 15 points
- No motor fluctuations or dyskinesias
- Stable medication for 4 weeks prior to inclusion
Main exclusion criteria:
- Atypical parkinsonian syndromes
- Dyskinesias or motor fluctuations
- Coenzyme Q10 treatment in the past
- Pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Parkinson's disease according to the UK Brain Bank criteria
- Hoehn \& Yahr stadium II until III
- Male or female
- Age 40 to 75 years
- UPDRS Part III > 15 points
Key exclusion criteria (9 listed)
- Atypical or drug-induced parkinsonian syndromes
- Dyskinesias or motor fluctuations
- Coenzyme Q10 treatment in the past
- Pregnancy
- Epileptic seizures in the history
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 Nanodispersion (Nanoquinone) | Drug | – |
| Placebo | Drug | – |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III
10 secondary outcomes
Total UPDRS
Safety
PDQ-39
SF36
CGI
Schwab&England
Montgomery-Asperg
Pain
Incontinence
Sexual behavior
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 19 Jan 2009.
- Results publication: PubMed 17502459Storch A, Jost WH, Vieregge P, Spiegel J, Greulich W, Durner J, Muller T, Kupsch A, Henningsen H, Oertel WH, Fuchs G, Kuhn W, Niklowitz P, Koch R, Herting B, Reichmann H; German Coenzyme Q(10) Study Group. Randomized, double-blind, placebo-controlled trial on symptomatic effects of coenzyme Q(10) in Parkinson disease. Arch Neurol. 2007 Jul;64(7):938-44. doi: 10.1001/archneur.64.7.nct60005. Epub 2007 May 14.
- Homepage of Principle study centerLink 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.
Heinz Reichmann, MD principal investigator
Technical University of Dresden
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coenzyme Q10 Nanodispersion (Nanoquinone) in people with Parkinson's Disease, run by Technische Universität Dresden at 13 sites 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 10 inclusion and 9 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 19 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00180037, which also lists 1 linked publication.
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 19 Jan 2009.