Open-Label Study to Assess the Effect of Fampridine-PR on Quality of Life as Reported by Subjects With Multiple Sclerosis (ENABLE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Biogen Idec.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01480076
First received: November 23, 2011
Last updated: September 12, 2013
Last verified: July 2012

November 23, 2011
September 12, 2013
February 2012
September 2013   (final data collection date for primary outcome measure)
Physical componenet 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 ]
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
Not Provided
Not Provided
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Open-Label Study to Assess the Effect of Fampridine-PR on Quality of Life as Reported by Subjects 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

A multicenter, open-label study to assess subject QoL as reported by responders to long-term treatment fampridine-PR 10 mg twice daily. Subjects classified as non-responders (those who did not meet criteria for continued fampridine treatment in this study) at Week 4 will stop treatment but will continue to provide QoL data for comparative purposes.

This is a multicenter, open-label study to assess QoL as reported by responders to long-term treatment with prolonged-release fampridine 10 mg twice daily. This study has 2 components: a 4-week run-in period during which subjects 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 subjects 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
10 Mg twice daily
Other Names:
  • fampridine-ER
  • dalfampridine
  • fampridine-PR
  • fampridine-SR
Fampridine
All patients take 10 Mg fampridine twice daily for the first 4 weeks. If deemed treatment responder to continue 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.
 
Active, not recruiting
800
October 2013
September 2013   (final data collection date for primary outcome measure)

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.
  • Male or female subjects, 18 to 75 years old, inclusive, at the time of informed consent.
  • 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 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.

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 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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Portugal,   Denmark,   France,   Italy,   Netherlands,   United Kingdom,   Australia,   Germany
 
NCT01480076
218MS403
Not Provided
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
July 2012

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