Progressive Supranuclear PalsyPhase 2/3NCT00532571
Effects of Coenzyme Q10 in PSP and CBD
A Phase 2/3 study testing CoQ10 in people with Progressive Supranuclear Palsy and Neurological Disorders, run by Lahey Clinic at 1 site in United States.
Trial summary
To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP) ). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Progressive Supranuclear Palsy, Neurological Disorders
- What is being tested?
- CoQ10
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Sep 2005
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling the diagnostic criteria of PSP and CBD (above) and who were diagnosed within the past 5 years
- Age > 40
- Subjects receiving anticholinergics, amantadine, dopamine agonists, carbidopa/levodopa, eldepryl, or comtan must be on a stable dose for at least 30 days prior to baseline visit.
- Patients agreeable to participate in the study.
Who cannot join
- Prior or concurrent therapy with anticholinergics, amantadine,a dopamine agonist,carbidopa/levodopa or comtan within 30 days of the baseline visit.
- Parkinsons disease or any other atypical parkinsonism; Parkinsonism due to drugs.
- History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant.
- Previous use of coenzyme Q10 within 60 days of the baseline visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Coenzyme Q10 in PSP and CBD, A Randomized, Placebo-Controlled, Double Blind Cross Over Pilot Study
To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP) ).
- Being tested
- CoQ10
- Keywords
- CoQ10, PSP, CBD
- Medical subject headings
- Supranuclear Palsy, Progressive, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startJan 2004
- Study completionSep 2005
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Diana Apetauerova, MD, Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532571
- Sponsor's protocol ID
- CoQ10 with PSP/CBD
- Status last verified
- Jun 2018
- First submitted
- 18 Sep 2007
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Coenzyme Q10 in PSP and CBD, A Randomized, Placebo-Controlled, Double Blind Cross Over Pilot Study
- ClinicalTrials.gov ID
- NCT00532571
- Acronym / sponsor ID
- CoQ10 with PSP/CBD
- Keywords
- CoQ10, PSP, CBD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Sep 2005
- First posted
- 20 Sep 2007 (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.
To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP) ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients fulfilling the diagnostic criteria of PSP and CBD (above) and who were diagnosed within the past 5 years
- Age > 40
- Subjects receiving anticholinergics, amantadine, dopamine agonists, carbidopa/levodopa, eldepryl, or comtan must be on a stable dose for at least 30 days prior to baseline visit.
- Patients agreeable to participate in the study.
Key exclusion criteria (4 listed)
- Prior or concurrent therapy with anticholinergics, amantadine,a dopamine agonist,carbidopa/levodopa or comtan within 30 days of the baseline visit.
- Parkinsons disease or any other atypical parkinsonism; Parkinsonism due to drugs.
- History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant.
- Previous use of coenzyme Q10 within 60 days of the baseline visit.
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 |
|---|---|---|
| CoQ10 | Drug | – |
Primary outcome
Not reported in the source record.
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 15 Jun 2018.
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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.
Diana Apetauerova, MD principal investigator
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CoQ10 in people with Progressive Supranuclear Palsy and Neurological Disorders, run by Lahey Clinic at 1 site in United States.
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 4 inclusion and 4 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 15 Jun 2018. 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 United States. 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 combined 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.
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.
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 15 Jun 2018.