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

Primary Purpose

Multiple Sclerosis, Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Alpha Lipoic Acid

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03493841

First Posted

March 21, 2018

Last Updated

March 20, 2019

Sponsor

Rebecca Spain

1. Study Identification

Unique Protocol Identification Number

NCT03493841

Brief Title

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

June 8, 2018 (Actual)

Primary Completion Date

January 25, 2019 (Actual)

Study Completion Date

January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rebecca Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Alpha Lipoic Acid

Other Intervention Name(s)

lipoic acid, R-lipoic acid

Intervention Description

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.

Primary Outcome Measure Information:

Title

Comparison of oral tolerance between R-LA and racemic LA

Description

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.

Title

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

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca Spain, MD, MSPH

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michelle Cameron, MD, PT, MCR

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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