Primary Progressive MS Clinical Trial
Official title:
A Randomized Double-Blind Placebo-Controlled Study of Caprylic Triglyceride for Cognitive Impairment in Subjects With Multiple Sclerosis.
Background/Rationale: Cognitive problems are a common symptom in individuals with Multiple
Sclerosis (MS). Treatment options are limited, and there is a pressing need for new
interventions to treat MS-related cognitive impairment. Glucose (a type of sugar) is used to
fuel the cells of the healthy brain. For people with neurological conditions such as MS,
glucose is not converted into energy as efficiently as it would be in a healthy brain, which
can lead to a decrease in cognitive function. Caprylic Triglyceride may work to bypass this
problem by providing an alternative energy source that is metabolized in the liver and used
by the brain.
Objective: To evaluate the therapeutic effects of 90 days of caprylic triglyceride on
cognitive impairment in multiple sclerosis.
Design: Randomized, double blinded, placebo controlled trial of 158 subjects.
Outcome: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd
Edition-(CVLT-II) AND Change in Symbol Digit Modalities Test (SDMT) (at day 90
Patients with all types of MS (Relapsing Remitting, Secondary Progressive, or Primary
Progressive) are eligible to participate. Participants will undergo detailed cognitive
assessment before initiating treatment and again after 90 days of treatment, to determine
whether Caprylic Triglyceride demonstrates a benefit over placebo.
Dosage: 40 gram packet orally once a day Duration of Treatment: 90 days
Analyses: Interim analyses will be conducted after 72 subjects have completed the trial and
objective STOP criteria for efficacy and futility have been defined in the protocol. Final
analyses will be an intent-to-treat (ITT) analysis to evaluate each of the primary aims.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01804647 -
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease
|