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

NCT03493841 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB #17951
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Progressive Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Comparison of oral tolerance between R-LA and racemic LA

  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.

  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.

• Comparison of serum bioavailability as measured by Area Under the Curve (0-infinity) between R-LA and racemic LA

  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.

  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.

Study Arms (2)

Group A

EXPERIMENTAL

Group A will receive racemic lipoic acid first and R-lipoic acid second

Drug: Alpha Lipoic Acid

Group B

EXPERIMENTAL

Group B will receive R- lipoic acid first and racemic lipoic acid second

Drug: Alpha Lipoic Acid

Interventions

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.

Also known as: lipoic acid, R-lipoic acid

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Progressive Multiple Sclerosis
• years of age or older
• Able to give informed consent and adhere to the study activities
• Able to swallow large oral capsules

You may not qualify if:

• 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

Sponsors & Collaborators

• Rebecca Spain: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Rebecca Spain, MD, MSPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Michelle Cameron, MD, PT, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 11, 2018
• Study Start: June 8, 2018
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (1)