Clinical trial

Lipoic Acid for the Treatment of Progressive Multiple Sclerosis

Name
B2682-R
Description
The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.
Trial arms
Trial start
2018-07-01
Estimated PCD
2023-12-31
Trial end
2024-06-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Lipoic acid
1200 mg taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation.
Arms:
Arm 1: Lipoic Acid
Other names:
Alpha-lipoic acid
Placebo
The placebo comparator will be taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation
Arms:
Arm 2: Placebo
Size
115
Primary endpoint
Mobility: Timed 25 Foot Walk
Change in Timed 25 Foot Walk from baseline to year 2
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 115, 'type': 'ACTUAL'}}
Updated at
2024-01-05

1 organization

1 product

1 drug

1 indication