CompletedPhase 4Relapsing and progressiveNCT014800762011-003507-38

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders <0.0001
Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders <0.0001
Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders <0.0001
Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders <0.0001
Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Respondersleast squares mean 0.80.0007
Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Respondersleast squares mean 0.30.2299
Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Respondersleast squares mean 0.20.2531

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Results by group

Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders

Baseline, Months 3, 6, 9, 12

GroupValueIntervalNumber analysed
Responder4.2 units on a scale0.36 (Standard Error)666
Responder3.4 units on a scale0.38 (Standard Error)666
Responder3.2 units on a scale0.37 (Standard Error)666
Responder2.9 units on a scale0.37 (Standard Error)666

Responder

4.2

Responder

3.4

Responder

3.2

Responder

2.9

p = <0.0001

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Responder70776 (10.7%)
Non-responder1283 (2.3%)
All Participants83579 (9.5%)

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

  • Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders

    Baseline, Months 3, 6, 9, 12

    PainQuality of life (reported by participants)
  • Change from baseline in the PCS of the SF-36 measured over Months 3, 6, 9, and 12 among subjects who respond to treatment with prolonged-release fampridine.

    Quality of life (reported by participants)

Other measures (35)

  • Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12: Responders Versus Non-responders

    Baseline, Months 3, 6, 9, 12

    PainQuality of life (reported by participants)
  • Change From Baseline in the MCS of the SF-36 At Months 3, 6, 9, and 12

    Baseline, Months 3, 6, 9, 12

    PainQuality of life (reported by participants)
  • Change From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Score at Months 3, 6, 9, and 12

    Baseline, Months 3, 6, 9, 12

    Quality of life (reported by participants)
  • Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12

    Baseline, Months 3, 6, 9, 12

    Quality of life (reported by participants)
  • Change From Baseline in the Activities Limitation Scale of the Patient-Reported Indices for Multiple Sclerosis (PRIMUS) at Months 3, 6, 9, and 12

    Baseline, Months 3, 6, 9, 12

    Quality of life (reported by participants)
  • Change From Baseline in the Current Health State of EuroQoL Descriptive System of Health-related Quality of Life States Consisting of 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Months 3, 6, 9, And 12

    Baseline, Months 3, 6, 9, 12

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)
  • Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12

    Baseline, Months 3, 6, 9, 12

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)
  • Change From Baseline in Percent Work Time Missed Due to MS, by the Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) Questionnaire at Months 3, 6, 9, and 12

    Baseline, Months 3, 6, 9, 12

  • Change From Baseline in Percent Impairment While Working Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12

    Baseline, Months 3, 6, 9, 12

  • Change From Baseline in Percent Overall Work Impairment Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12

    Baseline, Months 3, 6, 9, 12

Who could take part

Relapsing and progressive · 18 to 75

Key Inclusion Criteria: * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations. * Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting multiple sclerosis (MS) per revised McDonald Committee criteria ([Polman et al, 2011]) as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration. * Have a walking impairment as determined by the Investigator. * Able to perform the Timed 25-foot Walk Test with or without a walking aid. * Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. * Able to understand and comply with the requirements of the protocol. Key Exclusion Criteria: * Known allergy to pyridine-containing substances or to any of the inactive ingredients in the prolonged-release fampridine tablet. * Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood. * An estimated creatinine clearance of \<80 mL/minute. * Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 [e.g., cimetidine]). * Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study. * Female subjects who are currently breastfeeding. * Previous exposure to fampridine. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

About this trial

In the sponsor's words

The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment responders. The secondary objectives of this study are to compare the change in the PCS of the SF-36 between treatment responders and non-responders, to evaluate change from baseline in additional quality of life measures among treatment responders as well as changes from baseline in treatment responders versus non-responders and to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.

Papers

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History

    1. Started

      Feb 2012

    2. Main results due

      Jul 2013

    3. Finished

      Aug 2013

    4. Results posted

      Nov 2016

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