Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Lipoic acid, alpha
What it measured
Main measures
Comparison of oral tolerance between R-LA and racemic LA
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.
Bladder, bowel and sexual functionPainSafetyComparison of serum bioavailability as measured by Area Under the Curve (0-infinity) between R-LA and racemic LA
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.
How the body handles the medicine
Who could take part
Progressive MS · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a three-week crossover study that will compare how the body absorbs and tolerates two different forms of lipoic acid: R form and racemic form.
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History
Started
Jun 2018
Main results due
Jan 2019
Finished
Jan 2019
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