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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: September 14, 2016
Last verified: September 2016
Results First Received: July 11, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Intervention: Drug: Fampridine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fampridine All participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.

Participant Flow:   Overall Study
    Fampridine
STARTED   901 [1] 
Intent to Treat Population   835 [2] 
COMPLETED   611 
NOT COMPLETED   290 
Run-in Failure                52 
Adverse Event                39 
Death                2 
Disease Progression                5 
Non-compliance With Study Protocol                15 
Withdrawal by Subject                105 
Lost to Follow-up                7 
Investigator Decision                13 
Not Specified                52 
[1] enrolled and started run-in treatment
[2] Received ≥1 dose of study drug & provided ≥1 efficacy assessment at Baseline & the 3-month visit.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population: all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit.

Reporting Groups
  Description
Responder Participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks.
Non-responder Participants took 10 mg fampridine twice daily for the first 4 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
Total Total of all reporting groups

Baseline Measures
   Responder   Non-responder   Total 
Overall Participants Analyzed 
[Units: Participants]
 707   128   835 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.3  (9.70)   50.5  (10.0)   49.5  (9.75) 
Gender 
[Units: Participants]
     
Female   402   79   481 
Male   305   49   354 


  Outcome Measures
  Show All Outcome Measures

1.  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: Responders   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

2.  Secondary:   Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12: Responders Versus Non-responders   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

3.  Secondary:   Change From Baseline in the MCS of the SF-36 At Months 3, 6, 9, and 12   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

4.  Secondary:   Change From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Score at Months 3, 6, 9, and 12   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

5.  Secondary:   Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

6.  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   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

7.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

8.  Secondary:   Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

9.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

10.  Secondary:   Change From Baseline in Percent Impairment While Working Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

11.  Secondary:   Change From Baseline in Percent Overall Work Impairment Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

12.  Secondary:   Change From Baseline in Regular Activity Productivity Loss, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

13.  Secondary:   Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

14.  Secondary:   Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

15.  Secondary:   Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

16.  Secondary:   Change From Baseline in the MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

17.  Secondary:   Change From Baseline in the Activity Limitation Scale (ALS) of PRIMUS Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

18.  Secondary:   Change From Baseline in Current Health State of the EQ-5D VAS at Months 3, 6, 9, and 12 by MS Disease Type: Responders   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

19.  Secondary:   Change From Baseline in EQ-5D Index Scores at Months 3, 6, 9, and 12 by MS Disease Type: Responders   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

20.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

21.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

22.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

23.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

24.  Secondary:   Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

25.  Secondary:   Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

26.  Secondary:   Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

27.  Secondary:   Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy   [ Time Frame: Months 3, 6, 9, and 12 ]

28.  Secondary:   Change From Baseline in the Activities Limitation Scale of the PRIMUS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

29.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

30.  Secondary:   Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy   [ Time Frame: Baseline, Months 3, 6, 9, 12 ]

31.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

32.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

33.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

34.  Secondary:   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   [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]

35.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)   [ Time Frame: 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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Biogen Study Medical Director
Organization: Biogen
e-mail: clinicaltrials@biogen.com



Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01480076     History of Changes
Other Study ID Numbers: 218MS403
Study First Received: November 23, 2011
Results First Received: July 11, 2016
Last Updated: September 14, 2016
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