ENABLE
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| 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: Responders | least squares mean 0.8 | 0.0007 | |
| 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: Responders | least squares mean 0.3 | 0.2299 | |
| 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: Responders | least squares mean 0.2 | 0.2531 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Dalfampridine
Voltage-gated potassium channel blocker
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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Responder | 4.2 units on a scale | 0.36 (Standard Error) | 666 |
| Responder | 3.4 units on a scale | 0.38 (Standard Error) | 666 |
| Responder | 3.2 units on a scale | 0.37 (Standard Error) | 666 |
| Responder | 2.9 units on a scale | 0.37 (Standard Error) | 666 |
Responder
Responder
Responder
Responder
p = <0.0001
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Responder | 707 | 76 (10.7%) | |
| Non-responder | 128 | 3 (2.3%) | |
| All Participants | 835 | 79 (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
Loading reviews and guidelines…
Related trials
- ENHANCE
Phase 3 · Completed
Met its main goal
- RETRAP
Phase 4 · Completed
No result found
- MOTION - JAPAN
Phase 3 · Completed
No result found
- Does Fampridine SR Improve Cognitive Fatigue in Multiple …
Phase 2 / Phase 3 · Completed
No result found
- MOBILE
Phase 2 · Completed
Result in a paper, not read yet
- FAMPKIN
Phase 2 · Status unknown
Result in a paper, not read yet
History
Started
Feb 2012
Main results due
Jul 2013
Finished
Aug 2013
Results posted
Nov 2016
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error