NCT00676156

Brief Summary

The purpose of this study is to learn about an investigational drug known as oral lipoic acid (LA) that may help treat multiple sclerosis. This study will measure how a person's body absorbs and breaks down the drug (pharmacokinetics) and will compare four different forms of the drug from four different manufacturers as well as LA in conjunction with fish oil.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Dec 2005

Typical duration for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

May 7, 2008

Last Update Submit

November 2, 2012

Conditions

Multiple Sclerosis

Keywords

multiple sclerosislipoic acidLApharmacokineticsimmunological effects

Outcome Measures

Primary Outcomes (1)

  • To determine the pharmacokinetics of orally administered LA 1200 mg. This will assess the variability in bioavailability of LA and the feasibility of conducting a more focused PK assessment in future studies with LA.

    November 2008

Secondary Outcomes (1)

  • To study salivary LA concentrations corresponding to the serum levels.

    November 2008

Study Arms (3)

A

ACTIVE COMPARATOR

This arm involves a 1-day pharmacokinetics study of three different formulations of oral lipoic acid.

Drug: oral lipoic acid (LA)

B

ACTIVE COMPARATOR

This arm will examine the pharmacokinetics of LA with and without fish oil supplement in a cross over design.

Drug: lipoic acid (LA) with fish oil and LA without fish oil

C

ACTIVE COMPARATOR

This arm will include the study of a single dose of R enantiomer lipoic acid.

Drug: R lipoic acid

Interventions

oral lipoic acid (LA)DRUG

A single 1200 mg dose of oral LA will be administered.

A
lipoic acid (LA) with fish oil and LA without fish oilDRUG

Subjects will be randomized to receive either 1 dose of 1200 mg LA with fish oil and then will be crossed-over to receive 1 dose of 1200 LA without fish oil. There will be a 1-week wash out period between the cross over.

B
R lipoic acidDRUG

A single oral dose of 1200mg R enantiomer LA will be administered.

C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Definite MS by McDonald's or Poser's criteria
  • EDSS ≤ 7.5
  • Age 18 to 80

You may not qualify if:

  • No clinically significant MS exacerbation within 30 days of the screening
  • No systemically administered corticosteroids within 30 days of study entry
  • Patient not pregnant or breast feeding
  • No LA in previous 2 weeks
  • Not on anti-coagulants such as heparin, coumadin, or aspirin during study
  • No other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events
  • Inability to give informed consent
  • Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University Multiple Sclerosis Dept.

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Thioctic AcidFish Oils

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipidsOils

Study Officials

  • Vijayshree Yadav, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 12, 2008

Study Start

December 1, 2005

Primary Completion

February 1, 2008

Study Completion

November 1, 2008

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

US(1)