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 (ENABLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01480076
First received: November 23, 2011
Last updated: April 2, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: Fampridine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome 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 as Reported by Participants Who Responded to Treatment [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by disease type.


Secondary Outcome 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 As Reported By Participants Comparing Participants Who Responded To Treatment to Those Who Did Not Respond [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by responders and non-responders not taking additional multiple sclerosis (MS) therapy.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by disease type.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by responders and non-responders not taking additional MS therapy.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by disease type.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by responders and non-responders not taking additional MS therapy.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Data collected where a validated version is available in the local language. Results are also stratified by disease type.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by disease type.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by responders and non-responders not taking additional MS therapy.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by disease type.

  • 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 [ Time Frame: Day 1 (baseline), months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    Results are also stratified by responders and non-responders not taking additional MS therapy.

  • Number Of Participants With Adverse Events [ Time Frame: Day 1 Up To Month 12 ] [ Designated as safety issue: Yes ]

Enrollment: 901
Study Start Date: February 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (BIIB041) Fampridine
All patients take 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, participant continues 10 mg fampridine twice daily for 44 weeks. Non treatment responders can continue without treatment by completing quality of life questionnaires.
Drug: Fampridine
Supplied as a 10 mg twice daily tablet and taken twice daily. Doses must be spaced at least 12 hours apart.
Other Names:
  • Fampyra
  • BIIB041
  • Ampyra
  • dalfampridine
  • fampridine prolonged-release tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480076

Locations
United States, California
Glendale Adventist Medical Center
Glendale, California, United States
United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
MD Clinical
Hallandale Beach, Florida, United States
Compass Research, LLC
Orlando, Florida, United States, 32806
Compass Research, LLC
Orlando, Florida, United States
Italy
Ospedale San Raffaele
Milano, Italy
Netherlands
Research Site
Eindhoven, Netherlands
Portugal
Centro Hospitalar de Coimbra, EPE
Coimbra, Portugal
United Kingdom
Royal Hallamshire Hospitals NHS Trust
Sheffield, United Kingdom
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01480076     History of Changes
Other Study ID Numbers: 218MS403
Study First Received: November 23, 2011
Last Updated: April 2, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Italy: Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Portugal: Ethics Committee for Clinical Research
France: Institutional Ethical Committee
Greece: Ethics Committee
Denmark: Ethics Committee
Portugal: National Pharmacy and Medicines Institute
Netherlands: Independent Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Germany: Federal Institute for Drugs and Medical Devices
Australia: Human Research Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biogen:
Quality of Life
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
4-Aminopyridine
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Potassium Channel Blockers
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015