Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— ENABLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480076
• Other study ID #: 218MS403
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2011
• Last updated: April 2, 2015
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: April 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyItaly: Ethics CommitteeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Portugal: Ethics Committee for Clinical ResearchFrance: Institutional Ethical CommitteeGreece: Ethics CommitteeDenmark: Ethics CommitteePortugal: National Pharmacy and Medicines InstituteNetherlands: Independent Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Germany: Federal Institute for Drugs and Medical DevicesAustralia: Human Research Ethics CommitteeFrance: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the effect of long-term treatment with prolonged-release (BIIB041) (fampridine) 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 QoL 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 901
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 (PHI) in accordance with national and local subject privacy regulations.

• Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting 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 (T25FW 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 (CrCl) 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fampridine
Supplied as a 10 mg twice daily tablet and taken twice daily. Doses must be spaced at least 12 hours apart.

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano
Netherlands	Research Site	Eindhoven
Portugal	Centro Hospitalar de Coimbra, EPE	Coimbra
United Kingdom	Royal Hallamshire Hospitals NHS Trust	Sheffield
United States	Brain Matters Research	Delray Beach	Florida
United States	Glendale Adventist Medical Center	Glendale	California
United States	MD Clinical	Hallandale Beach	Florida
United States	Compass Research, LLC	Orlando	Florida
United States	Compass Research, LLC	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Italy,  Netherlands,  Portugal,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 as Reported by Participants Who Responded to Treatment	Results are also stratified by disease type.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	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 As Reported By Participants Comparing Participants Who Responded To Treatment to Those Who Did Not Respond	Results are also stratified by responders and non-responders not taking additional multiple sclerosis (MS) therapy.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The Individual Components and Mental Component Scale (MCS) Of The Short Form (36) Health Status Questionnaire (SF-36) At Months 3, 6, 9, And 12 As Reported By Participants Who Responded To Treatment	Results are also stratified by disease type.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The Individual Components and Mental Component Scale (MCS) At Months 3, 6, 9, And 12 As Reported By Participants Comparing Participants Who Responded To Treatment to Those Who Did Not Respond to Treatment	Results are also stratified by responders and non-responders not taking additional MS therapy.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The Multiple Sclerosis Impact Scale (MSIS-29) Physical and Psychological Score At Months 3, 6, 9, And 12 As Reported By Participants Who Responded To Treatment	Results are also stratified by disease type.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The Multiple Sclerosis Impact Scale (MSIS-29) Physical and Psychological Score At Months 3, 6, 9, And 12 As Reported By Participants Comparing Participants Who Responded To Treatment to Those Who Did Not Respond to Treatment	Results are also stratified by responders and non-responders not taking additional MS therapy.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The Activities Limitation scale of the Patient-Reported Indices for Multiple Sclerosis (PRIMUS) At Months 3, 6, 9, And 12 As Reported By Participants Who Responded To Treatment	Data collected where a validated version is available in the local language. Results are also stratified by disease type.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The Activities Limitation scale of the Patient-Reported Indices for Multiple Sclerosis (PRIMUS) At Months 3, 6, 9, And 12 As Reported By Participants Comparing Participants Who Responded To Treatment to Those Who Did Not Respond	Data collected where a validated version is available in the local language. Results are also stratified by responders and non-responders not taking additional MS therapy.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The EuroQoL Descriptive System of Health-related Quality of Life States Consisting of 5 Dimensions (EQ-5D) At Months 3, 6, 9, And 12 As Reported By Participants Who Responded To Treatment	Results are also stratified by disease type.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The Change From Baseline In The EuroQoL Descriptive System of Health-related Quality of Life States Consisting of 5 Dimensions (EQ-5D) At Months 3, 6, 9, And 12 As Reported By Participants Comparing Participants Who Responded To	Results are also stratified by responders and non-responders not taking additional MS therapy.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The Work Productivity and Activity Impairment (WPAI)-Specific Health Problem (SHP) Questionnaire At Months 3, 6, 9, And 12 As Reported By Participants Who Responded To Treatment	Results are also stratified by disease type.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Change From Baseline In The Work Productivity and Activity Impairment (WPAI)-Specific Health Problem (SHP) Questionnaire At Months 3, 6, 9, And 12 As Reported By Participants Comparing Participants Who Responded To Treatment to Those Who Did Not Respond	Results are also stratified by responders and non-responders not taking additional MS therapy.	Day 1 (baseline), months 3, 6, 9, 12	No
Secondary	Number Of Participants With Adverse Events		Day 1 Up To Month 12	Yes