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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01537549 |
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Date of registration:
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09/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy
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Scientific title:
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An Open-label Trial of Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy (PSP): Effect Upon Oxidative Damage and Mitochondrial Biomarkers |
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Date of first enrolment:
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September 14, 2010 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01537549 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Claire Henchcliffe, MD DPhil |
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Address:
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Telephone:
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Email:
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Affiliation:
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Weill Medical College of Cornell University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of probable PSP by NINDS/PSP workshop criteria (see patient folder)
- Age 40-75 years
- Able to undergo MRI
- Absence of significant medical, psychiatric, and other neurological disease
- Stable intake of supplements and medication
Exclusion Criteria:
- Failure to meet probable PSP diagnosis by NINDS/PSP workshop criteria
- unable to comply with informed consent process
- unable to undergo MRI
- presence of significant medical, psychiatric (incl MDD) or other neurological (incl
epilepsy, brain tumor, stroke) disease
- possibility of pregnancy (negative test required in women of childbearing age)
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Progressive Supranuclear Palsy
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Intervention(s)
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Drug: alpha-lipoic acid and L-acetyl carnitine
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Primary Outcome(s)
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Adverse Events
[Time Frame: at 25 weeks]
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Secondary Outcome(s)
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Cerebral Oxidative Stress Markers
[Time Frame: at baseline and at week 5]
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Secondary ID(s)
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IRB1006011088
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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