An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple Sclerosis

Biogen1 site in 1 country901 target enrollmentFebruary 2012

ConditionsMultiple Sclerosis

InterventionsFampridine

DrugsFampridine

Overview

Phase: Phase 4
Intervention: Fampridine
Conditions: Multiple Sclerosis
Sponsor: Biogen
Enrollment: 901
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

This study has 2 components: a 4-week run-in period during which participants are treated with prolonged-release fampridine and undergo subjective and objective assessments of walking ability, the results of which are used to determine who responded to study treatment, and an observational period, during which treatment responders will continue prolonged-release fampridine treatment. The participants who do not meet the criteria to continue study treatment will be offered the opportunity to continue study participation but will not continue prolonged-release fampridine treatment.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

August 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Arms & Interventions

(BIIB041) Fampridine

All participants take 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, a participant continues 10 mg fampridine twice daily for 44 weeks. Treatment non-responders can continue without treatment by completing quality of life questionnaires.

Intervention: Fampridine

Outcomes

Primary Outcomes

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

Time Frame: Baseline, Months 3, 6, 9, 12

The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. Within-group least squares means are presented.

Secondary Outcomes

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)
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)
Change From Baseline in the MCS of the SF-36 At Months 3, 6, 9, and 12(Baseline, Months 3, 6, 9, 12)
Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, and 12)
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)
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)
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 the PCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12(Baseline, Months 3, 6, 9, 12)
Change From Baseline in the Index Scores of EQ-5D 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 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)
Change From Baseline in Current Health State of the EQ-5D VAS at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Months 3, 6, 9, and 12)
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)(From signing of Informed Consent (SAEs) or from first dose of study treatment (AEs) through Week 50 or Early Termination (14 +/- 7 days after last dose))
Change From Baseline in Regular Activity Productivity Loss, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12(Baseline, Months 3, 6, 9, 12)
Change From Baseline in the MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in the Activity Limitation Scale (ALS) of PRIMUS Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in EQ-5D Index Scores at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in the Current Health State of EQ-5D VAS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, 12)
Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, 12)
Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, 12)
Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, 12)
Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in the Activities Limitation Scale of the PRIMUS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, 12)
Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, and 12)
Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy(Baseline, Months 3, 6, 9, and 12)