Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02219932
• Date of registration: 18/08/2014
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis ENHANCE
• Scientific title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects With Multiple Sclerosis (ENHANCE)
• Date of first enrolment: September 2014
• Target sample size: 646
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02219932
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Bulgaria, Czech Republic, Finland, Germany, Italy, Lithuania, Netherlands, Poland, Russian Federation, Serbia, Switzerland, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Must have a diagnosis of primary-progressive, secondary-progressive,
progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee
criteria [McDonald 2001; Polman 2005] as defined by Lublin and Reingold [Lublin and
Reingold 1996] of at least 3 months duration

- Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive

- Must have walking impairment, as deemed by the Investigator

Key Exclusion Criteria:

- History of human immunodeficiency virus (HIV)

- Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis
infection that has been serologically confirmed as resolved are not excluded from
study participation

- Known allergy to fampridine, pyridine-containing substances, or any of the inactive
ingredients in the prolonged-release fampridine tablet

- Creatinine clearance (CrCl) of <80 mL/min

- History of malignant disease

- Presence of pulmonary disease

- A body mass index (BMI) =40 (BMI formula: BMI = mass [kg]/[height(m)]2)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Placebo

Drug: fampridine

Primary Outcome(s)

Proportion of Participants Achieving a Mean Improvement of = 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks [Time Frame: Baseline to 24 weeks]

Secondary Outcome(s)

Change From Baseline in ABILHAND Score Over 24 Weeks [Time Frame: Baseline to Week 24]

Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks [Time Frame: Baseline to Week 24]

Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks [Time Frame: Baseline to Week 24]

Proportion of Participants Achieving a Mean Improvement From Baseline of = 15% in Timed Up and Go (TUG) Speed Over 24 Weeks [Time Frame: Baseline to Week 24]

Secondary ID(s)

218MS305

2013-003600-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02219932