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NCT Number: NCT03493841

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

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Progressive Multiple Sclerosis Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha lipoic acid

Drug

Lipoic acid is an over the counter supplement. Two different forms, R and racemic are available. R-lipoic acid is the naturally occurring form. Racemic lipoic acid is the most commonly available supplement.

Other names: lipoic acid, R-lipoic acid

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

Sponsors and collaborators

Lead sponsor

Rebecca Spain

Other

Registry information

Official study title

Comparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2018
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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