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August 20, 2019; 93 (8) Article

Effect of dalfampridine on information processing speed impairment in multiple sclerosis

Laura De Giglio, Francesca De Luca, Flavia Gurreri, Ilaria Ferrante, Luca Prosperini, Giovanna Borriello, Esmeralda Quartuccio, Claudio Gasperini, Carlo Pozzilli
First published July 22, 2019, DOI: https://doi.org/10.1212/WNL.0000000000007970
Laura De Giglio
From the MS Center Sant’Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
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Francesca De Luca
From the MS Center Sant’Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
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Flavia Gurreri
From the MS Center Sant’Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
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Ilaria Ferrante
From the MS Center Sant’Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
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Luca Prosperini
From the MS Center Sant’Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
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Giovanna Borriello
From the MS Center Sant’Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
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Esmeralda Quartuccio
From the MS Center Sant’Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
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Claudio Gasperini
From the MS Center Sant’Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
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Carlo Pozzilli
From the MS Center Sant’Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
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Effect of dalfampridine on information processing speed impairment in multiple sclerosis
Laura De Giglio, Francesca De Luca, Flavia Gurreri, Ilaria Ferrante, Luca Prosperini, Giovanna Borriello, Esmeralda Quartuccio, Claudio Gasperini, Carlo Pozzilli
Neurology Aug 2019, 93 (8) e733-e746; DOI: 10.1212/WNL.0000000000007970

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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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