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Abstract
Objective To test a possible benefit of dalfampridine on information processing speed (IPS), a key function for cognitive impairment (CogIm) in multiple sclerosis (MS).
Methods In this randomized, double-blind, placebo-controlled trial, we included patients with a score on the Symbol Digit Modalities Test (SDMT) under the 10th percentile of the reference value. Patients were randomized in a 2:1 ratio to receive dalfampridine 10 mg or placebo twice daily for 12 weeks. They underwent a comprehensive neuropsychological evaluation at screening (T0), at the end of treatment (T1), and after a 4-week follow-up (T2). The primary endpoint was improvement in SDMT.
Results Out of 208 patients screened, 120 were randomized to receive either dalfampridine (n = 80) or placebo (n = 40). At T1, the dalfampridine group presented an increase of SDMT scores vs placebo group (mean change 9.9 [95% confidence interval (CI) 8.5–11.4] vs 5.2 [95% CI 2.8–7.6], p = 0.0018; d = 0.60 for raw score; and 0.8 [95% CI 0.6–1] vs 0.3 [95% CI 0.0–0.5], p = 0.0013; d = 0.61 for z scores; by linear mixed model with robust standard error). The improvement was not sustained at T2. A beneficial effect of dalfampridine was observed in the Paced Auditory Serial Addition Test and in cognitive fatigue.
Conclusion Dalfampridine could be considered as an effective treatment option for IPS impairment in MS.
Trial registration 2013-002558-64 EU Clinical Trials Register.
Classification of evidence This study provides Class I evidence that for patients with MS with low scores on the SDMT, dalfampridine improves IPS.
Glossary
- 9-HPT=
- 9-Hole Peg Test;
- 25FWT=
- Timed 25-Foot Walk Test;
- BDI=
- Beck Depression Inventory;
- BRB-N=
- Rao Brief Repeatable Battery of Neuropsychological Tests;
- CI=
- confidence interval;
- CogIm=
- cognitive impairment;
- DMT=
- disease-modifying treatment;
- IPS=
- information processing speed;
- MFIS=
- Modified Fatigue Impact Scale;
- MS=
- multiple sclerosis;
- MSFC=
- Multiple Sclerosis Functional Composite;
- MSIS29=
- Multiple Sclerosis Impact Scale;
- PASAT-2=
- Paced Auditory Serial Addition Test, 2 seconds rate;
- PASAT-3=
- Paced Auditory Serial Addition Test, 3 seconds rate;
- SDMT=
- Symbol Digit Modalities Test;
- SPART=
- Spatial Recall Test;
- SRT-CLTR=
- Selective Reminding Test–Consistent Long-Term Retrieval;
- SRT-D=
- Selective Reminding Test–Delayed Recall;
- SRT-LTS=
- Selective Reminding Test–Long-Term Storage;
- ST=
- Stroop Test;
- TOW=
- Tower of London test;
- WLG=
- Word List Generation
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Editorial, page 325
Class of Evidence: NPub.org/coe
CME Course: NPub.org/cmelist
- Received August 26, 2018.
- Accepted in final form April 30, 2019.
- © 2019 American Academy of Neurology
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