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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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12 December 2020 |
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Main ID: |
NCT03493841 |
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Date of registration:
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21/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis
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Scientific title:
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Comparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover Trial |
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Date of first enrolment:
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June 8, 2018 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03493841 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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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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Rebecca Spain, MD, MSPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Name:
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Michelle Cameron, MD, PT, MCR |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of Progressive Multiple Sclerosis
- 18 years of age or older
- Able to give informed consent and adhere to the study activities
- Able to swallow large oral capsules
Exclusion Criteria:
- Clinical Multiple Sclerosis relapse in the prior 1 year
- Oral or IV steroids in the prior 3 months
- Have taken LA in last 30 days
- Clinically significant kidney disease as determined by the PI including, but not
limited to, major kidney disease diagnoses, abnormal laboratory values related to
renal function, or other related conditions
- Insulin-dependent diabetes
- Other significant ongoing medical illness that may interfere with study procedures
- Taking oral anticoagulants (e.g. Coumadin). Aspirin, clopidogrel, and dipyridamole are
acceptable to take
- Pregnant or breast-feeding
- Any condition which would make the patient, in the opinion of the investigator,
unsuitable for the study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Progressive Multiple Sclerosis
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Multiple Sclerosis
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Secondary Progressive Multiple Sclerosis
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Primary Progressive Multiple Sclerosis
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Intervention(s)
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Drug: Alpha Lipoic Acid
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Primary Outcome(s)
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Comparison of serum bioavailability as measured by Area Under the Curve (0-infinity) between R-LA and racemic LA
[Time Frame: Obtained at first (Visits 1 and 3) and last doses (visits 2 and 4) of each form of LA. Each visit is approximately a week apart.]
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Comparison of oral tolerance between R-LA and racemic LA
[Time Frame: Obtained at first (Visits 1 and 3) and last doses (visits 2 and 4) of each form of LA. Each visit is approximately a week apart.]
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Secondary ID(s)
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IRB #17951
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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