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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 (ENABLE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01480076
First received: November 23, 2011
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


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:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Enrollment: 800
Study Start Date: February 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Fampridine
10 Mg twice daily
Other Names:
  • fampridine-ER
  • dalfampridine
  • fampridine-PR
  • fampridine-SR

Detailed Description:

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.

  Eligibility

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

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

Locations
Australia
St Vincent's Hospital
Fitzroy, Australia
Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Denmark
Dansk Multipel Sclerose Center
København, Denmark
France
Nouvel Hôpital Civil, Clinique Neurologique
Strasbourg, France
Germany
Univeristaetsklinikum Jena
Jena, Germany
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 Idec
  More Information

No publications provided

Responsible Party: Medical Director, Biogen Idec Ltd
ClinicalTrials.gov Identifier: NCT01480076     History of Changes
Other Study ID Numbers: 218MS403
Study First Received: November 23, 2011
Last Updated: July 5, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on May 16, 2013