Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis

Phase 1

Completed

• Conditions: Multiple Sclerosis; Progressive Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis
• Interventions: Drug: Alpha Lipoic Acid

• Registration Number: NCT03493841
• Lead Sponsor: Rebecca Spain

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.

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-11
• Study Start: 2018-06-08
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Alpha Lipoic Acid	Group A will receive racemic lipoic acid first and R-lipoic acid second
Group B	Alpha Lipoic Acid	Group B will receive R- lipoic acid first and racemic lipoic acid second

Primary Outcome Measures

Name	Time	Method
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.	Oral tolerance will be determined by the completion of a modified Monitoring of Side Effects Scale at each study visit. This scale asks the participant to rate the following side effects: abdominal pain, appetite: decreased, appetite: increased, constipation, diarrhea, flatulence, nausea/vomiting, taste abnormality (metallic, etc.), thirst: increased, thirst: decreased, and weight: increased. Each side effect will be rated on severity. 0 - the lowest possible score represents "not present". 4 - the highest possible score represents "severe". The relative change in total tolerance score will be compared between R-LA and racemic LA.
Comparison 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.	Serum bioavailability, as measured by Area Under the Curve (0-infinity) will be compared between R-LA and racemic LA by obtaining concentration values at times 0, 60, 90, 120, 180, and 240 minutes after ingestion of LA dose on the first (visits 1 and 3) and last doses (visits 2 and 4) of each LA form.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States