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

Biogen

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: fampridine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02219932

218MS305

2013-003600-40 (EudraCT Number)

Details and patient eligibility

About

The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period.

The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.

Enrollment: 646 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

646 participants in 2 patient groups, including a placebo group

Fampridine 10 mg BID

Experimental group

Description:

Prolonged-release fampridine 10 mg twice daily (BID) for up to 24 weeks

Treatment:

Drug: fampridine

Placebo

Placebo Comparator group

Description:

Matched placebo 10 mg BID for up to 24 weeks

Treatment:

Drug: Placebo