Clinical trial NCT03493841: Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis
Official title: Comparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This three-week double-blind crossover trial will compare two different forms of lipoic acid (LA). Every participant will take one week of daily oral 600mg R LA, have a one week washout period without LA, and take one week of daily oral 1200mg racemic LA. The order of LA type will be determined by randomization. Blood analyses will be performed to determine which form is better absorbed and a side effects questionnaire will be completed at each visit in order to determine which form is better tolerated.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of oral tolerance between R-LA and racemic LA
timeFrame: 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.
measure: Comparison of serum bioavailability as measured by Area Under the Curve (0-infinity) between R-LA and racemic LA
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Rebecca Spain, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Michelle Cameron, MD, PT, MCR
role: PRINCIPAL_INVESTIGATOR
References: