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

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ClinicalTrials.gov Identifier: NCT03493841
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Rebecca Spain, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis Primary Progressive Multiple Sclerosis Drug: Alpha Lipoic Acid Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover Trial
Actual Study Start Date : June 8, 2018
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Group A will receive racemic lipoic acid first and R-lipoic acid second
Drug: Alpha Lipoic Acid
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

Experimental: Group B
Group B will receive R- lipoic acid first and racemic lipoic acid second
Drug: Alpha Lipoic Acid
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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493841


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Rebecca Spain
Investigators
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Principal Investigator: Rebecca Spain, MD, MSPH Oregon Health and Science University
Principal Investigator: Michelle Cameron, MD, PT, MCR Oregon Health and Science University

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Responsible Party: Rebecca Spain, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03493841     History of Changes
Other Study ID Numbers: IRB #17951
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances