Lipoic Acid for Progressive Multiple Sclerosis (MS)

• Register: ClinicalTrials.gov
• Last refreshed on: 15 January 2024
• Main ID: NCT03161028
• Date of registration: 18/05/2017
• Prospective Registration: Yes
• Primary sponsor: VA Office of Research and Development
• Public title: Lipoic Acid for Progressive Multiple Sclerosis (MS) LAPMS
• Scientific title: Lipoic Acid for the Treatment of Progressive Multiple Sclerosis
• Date of first enrolment: July 1, 2018
• Target sample size: 115
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03161028
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Rebecca I. Spain, MD MSPH
• Affiliation: VA Portland Health Care System, Portland, OR

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of progressive MS as defined by the study

- Able to give informed consent and to adhere to study procedures.

- Expanded Disability Status Scale (EDSS) 3.0 - 6.5: ambulatory for at least 20 meters
without rest and use of bilateral aids (canes, crutches, walker) or better.

Exclusion Criteria:

- A self-reported medical or neurological problem other than MS that is a cause of
progressive or fluctuating gait dysfunction

- Unable to undergo MRI

- Unable to follow directions in English as standardized scales are not all validated in
other languages.

- Current major disease or disorder other than MS (e.g., cancer, renal disease,
end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may
interfere with study procedures. Note: Stable abnormal laboratory values of no more
than Grade 1 determined to not be of clinical significance to the primary treating
physician for that condition may be permitted per local site investigator discretion.

- Pregnant or breast-feeding.

- Insulin-dependent diabetes or diabetes not controlled on oral diabetes medications.

- Scheduled (every 3 months or more frequently) IV or oral steroids in the year prior to
enrolment.

- IV or oral steroids in the 60 days prior to enrolment.

- Use of LA in the prior 2 years exceeding the equivalent of 1200mg daily for 3 months.

- Participation in the pilot LA in SPMS trial.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Lipoic acid

Drug: Placebo

Primary Outcome(s)

Mobility: Timed 25 Foot Walk [Time Frame: Change in Timed 25 Foot Walk from baseline to year 2]

Secondary Outcome(s)

Brain Atrophy by MRI [Time Frame: % change brain volume from baseline to year 2]

Mobility: 2-minute timed walk [Time Frame: Change in 2-minute timed walk from baseline to year 2]

Mobility: Fall count [Time Frame: Change in number of falls recorded from baseline to year 2]

Secondary ID(s)

B2682-R

Source(s) of Monetary Support

Please refer to primary and secondary sponsors