CompletedPhase 1Phase 2Relapsing and progressiveNCT02133664

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
Paced Auditory Serial Addition Task (PASAT)Mean Difference (Final Values) 1.14-2.03–4.320.05

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Omega-3 fatty acids

Placebo or sham

  • Placebo

Results by group

Paced Auditory Serial Addition Task (PASAT)

Baseline to 12 weeks

GroupValueIntervalNumber analysed
Lipoic Acid and Omega-3 Fatty Acids2.24 correct responses4.69 (Standard Deviation)21
Placebo3.38 correct responses5.46 (Standard Deviation)21

Lipoic Acid and Omega-3 Fatty Acids

2.24

Placebo

3.38

p = 0.05; Mean Difference (Final Values) 1.14 (95% CI -2.03–4.32)

Stroop Color-Word Test

baseline to 12 weeks

GroupValueIntervalNumber analysed
Lipoic Acid and Omega-3 Fatty Acids-5.59 seconds12.77 (Standard Deviation)23
Placebo-2.87 seconds7.01 (Standard Deviation)23

Lipoic Acid and Omega-3 Fatty Acids

-5.59

Placebo

-2.87

California Verbal Learning Test-II (CVLT-II)

baseline to 12 weeks

GroupValueIntervalNumber analysed
Lipoic Acid and Omega-3 Fatty Acids1.57 correct responses1.85 (Standard Deviation)23
Placebo1.65 correct responses2.44 (Standard Deviation)23

Lipoic Acid and Omega-3 Fatty Acids

1.57

Placebo

1.65

Controlled Oral Word Association Test (COWAT)

baseline to 12 weeks

GroupValueIntervalNumber analysed
Lipoic Acid and Omega-3 Fatty Acids0.70 words7.71 (Standard Deviation)23
Placebo0.39 words7.14 (Standard Deviation)23

Lipoic Acid and Omega-3 Fatty Acids

0.7

Placebo

0.39

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Lipoic Acid and Omega-3 Fatty Acids262 (7.7%)0
Placebo280 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Paced Auditory Serial Addition Task (PASAT)

    Baseline to 12 weeks

    Thinking and memory
  • Stroop Color-Word Test

    baseline to 12 weeks

    Thinking and memory
  • California Verbal Learning Test-II (CVLT-II)

    baseline to 12 weeks

    Thinking and memory
  • Controlled Oral Word Association Test (COWAT)

    baseline to 12 weeks

Who could take part

Relapsing and progressive · 18 to 65

Inclusion Criteria: * • A definite diagnosis of multiple sclerosis (MS) with relapsing remitting or secondary progressive course * Age 18 to 65 years, inclusive * A score two or more standard deviations below the mean in one or more of the following cognitive tests: PASAT, COWAT, CVLT -II, Stroop * Expanded Disability Status Scale (EDSS) 0-7.5, inclusive * Suboptimal omega-3 levels (plasma docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA] \< 5.0% of total plasma fatty acids) * If taking MS disease modifying medications, on stable dose for > 6 months preceding enrollment * Able to read and write English Exclusion Criteria: * • Moderate to severe depression (Beck Depression Inventory score > 19) * Any significant uncontrolled medical problem including diabetes requiring insulin. * MS relapse within the 30 days before screening * Abnormalities of coagulation or current use of prescription anticoagulants or antiplatelet agents. Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are not excluded. * Fish intake of one 6 ounce serving > once a week less than 2 months prior to enrollment * Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 2 months prior to enrollment * Lipoic Acid supplementation less than 1 month prior to enrollment * Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion. * Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study. * Epilepsy or history of seizures. * Pregnancy or women not using a reliable form of contraception * Corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the Ishihara Color plates or sustained nystagmus or diplopia on primary gaze * Inability to complete the neuropsychological test battery at the screening visit * Participation in another intervention study

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The primary aim is to collect data to determine the correct effect size on the primary outcome to aid in the design of a larger study: The primary outcome is to determine if lipoic acid and omega-3 fatty acids can improve cognitive function in people with multiple sclerosis that have cognitive dysfunction.

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History

    1. Started

      Jun 2014

    2. Main results due

      May 2016

    3. Finished

      May 2016

    4. Results posted

      May 2017

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