Phase 3
Completed N=61
Effects of Dalfampridine on Cognition in Multiple Sclerosis
Source: ClinicalTrials.gov NCT02006160 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Symbol Digit Modalities Test — 41.18; 35.06; 45.05; 38.63 score on a scale
◆ Published Evidence
Established
22citations · ~4 / year
Dalfampridine benefits ambulation but not cognition in multiple sclerosis.
Summary
Cognitive impairment is common in multiple sclerosis (MS) and has devastating impact on functional activities. There is great demand for medications that will enhance cognitive capacity in MS patients. To date, there is no evidence for improvement in cognition following treatment with aminopyridines, but the few studies on the topic included neuropsychological (NP) tests as secondary or tertiary outcomes, and were methodologically flawed. Dalfampridine may enhance cognition by direct pharmacological mechanisms, and should have effects on motor outcomes as in prior studies. By combining cognition and motor outcomes in the proposed study, the investigators will evaluate if the same patients with positive effects show beneficial responses on motor outcomes including physical activity and if such motor outcomes mediate and/or moderate cognitive improvements with dalfampridine
Linked Publications
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Dalfampridine benefits ambulation but not cognition in multiple sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symbol Digit Modalities Test |
41.18; 35.06; 45.05; 38.63 | — |
Eligibility Criteria
Inclusion Criteria
Patients will be eligible for the study if they fulfill all the inclusion criteria specified below:
- Males/Females who are ≥ 18 years old and 28.
- An Expanded Disability Status Scale (EDSS) of ≤ 6.5.
- Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.
- Are capable of performing the requirements of a NP test battery including at least 20/70 near visual acuity by near vision chart, with correction allowed.
- If female, must neither be pregnant nor breast-feeding and must either (a) be > 12 months post-menopausal or surgically sterilized, or (b) agree to use an acceptable method of birth control for the duration of the study. Abstinence will not be considered an acceptable method of birth control.
Exclusion Criteria
- Have cognitive deficits caused by concomitant medication usage or other significant neurological/psychological disease e.g. Alzheimer's disease, Parkinson's disease, stroke, transient ischemic attack, Vascular Dementia, Huntington's disease, traumatic brain injury or chronic CNS infection
- Have evidence of other medical cause(s) of cognitive impairment
- Evidence of major mental illness predating the onset of MS
- Have evidence of major depression as determined by a positive BDIFS and clinician interview
- Have report of uncontrolled or labile hypertension, tachycardia, cardiovascular or cerebrovascular disease
- History of seizure disorder.
- Optic neuritis within 6 months of enrollment.
- Trigeminal neuralgia.
- Prior exposure to aminopyridines within the last six months.
Data sourced from ClinicalTrials.gov (NCT02006160) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.