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 Idec
ClinicalTrials.gov Identifier:
NCT01480076
First received: November 23, 2011
Last updated: April 2, 2015
Last verified: April 2015

November 23, 2011
April 2, 2015
February 2013
July 2013   (final data collection date for primary outcome measure)
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.
Physical component scale of the SF36 health questionnaire in treatment responders [ Time Frame: Change is measured over months 3,6,9 and 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01480076 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
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
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.
Intervention: Drug: Fampridine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
901
July 2013
July 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   Netherlands,   Portugal,   United Kingdom
France,   Australia,   Belgium,   Denmark,   Germany
 
NCT01480076
218MS403
Not Provided
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP