Primary outcomeNumber· at 24 weeks
Number of Adverse Events
| Group | Value (Number of Adverse Events) |
|---|---|
| Ubiquinol | 27 |
| Placebo | 12 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUbiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
NCTNCT03061513 (opens ClinicalTrials.gov in a new tab)Other id1112012060
This trial does not test a peptide that PepBank tracks.
- Names Glutathione, does not test it. It appears in the conditions.
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 11 participants (actual)
- Sponsor
- Weill Medical College of Cornell University · Other
- Design
- Randomized · Quadruple masking
- Countries
- Not stated
- Start
- 28 Feb 2012
- Primary completion
- 31 Dec 2016
- Completion
- 31 Dec 2016
- First posted
- 23 Feb 2017
- Last update posted
- 23 May 2017
- Conditions
- Parkinson Disease
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014201520162017
- Ph 2
Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
NCT0306151328 Feb 2012 to 31 Dec 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to find out whether ubiquinol is well tolerated, can affect the symptoms of Parkinson's Disease and change the energy levels in the brain. Subjects will be randomized to taking ubiquinol or placebo and will have a neurological evaluation, magnetic resonance spectroscopy (MRS) and blood test for biological markers taken during the study.
Interventions
- UbiquinolDrug
- PlaceboDietary supplement
Arms2
Active comparator
Ubiquinol
600mg ubiquinol daily for 24 weeks
Placebo comparator
Placebo
Placebo daily for 24 weeks
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Adverse Events
Time frame · at 24 weeks
Registry description
The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.
Secondary outcomes(1)
Cerebral Redox Markers
Time frame · at baseline and 8 weeks
Registry description
Change from baseline in lactate levels at 8 weeks as determined by Magnetic Resonance Spectroscopy
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMean· at baseline and 8 weeks
Cerebral Redox Markers
| Group | Value (Ratio) | Spread |
|---|---|---|
| Ubiquinol | -11.98 | 18.57 |
| Placebo | 6.23 | 23.19 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Ubiquinol600mg ubiquinol daily for 24 weeks Ubiquinol: Ubiquinol caplets 600mg/day | – | 0 / 6 | 5 / 6 |
| PlaceboPlacebo daily for 24 weeks Placebo: placebo | – | 0 / 5 | 3 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 40 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* diagnosis of PD according to the Untied Kingdom (UK) Brain Bank Criteria, and confirmed by a Movement Disorders neurologist;
* age 40-75 years; diagnosis within 5 years of study participation;
* PD medications able to remain at stable doses in the opinion of the enrolling investigator;
* able to undergo MRI;
* absence of significant medical, psychiatric, and other neurological disease;
* absence of dementia and Mini-Mental State Examination (MMSE) \> 26.
Exclusion Criteria:
* failure to meet diagnosis by above criteria;
* time since diagnosis \> 5 years before study participation;
* PD medications not predicted to remain at stable doses in the opinion of the enrolling investigator;
* unable to undergo MRI;
* unable to comply with informed consent process;
* presence of significant medical, psychiatric (including major depressive disorder) or other neurological (including epilepsy, brain tumor, stroke) disease;
* diagnosis of dementia and/or MMSE 26 or lower;
* possibility of pregnancy (negative test required in women of childbearing age);
* taking medications including antipsychotic agents and dopamine- blocking anti-emetic agents;
* taking Coenzyme Q10;
* participation in another clinical trial within the last 3 months.
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