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ENHANCE

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)
CompletedPhase 3Relapsing and progressiveNCT022199322013-003600-40

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 WeeksOdds Ratio (OR) 1.611.15–2.260.006
Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 WeeksRisk Difference for Adjusted Proportions 0.1040.030–0.178
Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 WeeksRelative Risk 1.381.06–1.70

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks

Baseline to 24 weeks

GroupValueIntervalNumber analysed
Placebo0.336 proportion of participants318
Fampridine 10 mg BID0.432 proportion of participants315

Placebo

0.336

Fampridine 10 mg BID

0.432

p = 0.006; Odds Ratio (OR) 1.61 (95% CI 1.15–2.26)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo31921 (6.6%)
Fampridine 10mg BID31625 (7.9%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks

    Baseline to 24 weeks

    Walking and mobility

  • The primary endpoint of this study is the proportion of subjects who achieve a mean improvement on the MSWS-12 of ≥8-points from baseline over a 24-week treatment period.

    Walking and mobility

Other measures (5)

  • Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks

    Baseline to Week 24

    Walking and mobility

  • Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks

    Baseline to Week 24

    Disability progressionQuality of life (reported by participants)

  • Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks

    Baseline to Week 24

    Disability progressionWalking and mobility

  • Change From Baseline in ABILHAND Score Over 24 Weeks

    Baseline to Week 24

    Disability progression

  • Proportion of subjects who achieve a mean improvement in TUG speed of ≥15% from baseline over a 24-week period

    Walking and mobility

Who could take part

Relapsing and progressive · 18 to 70

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Sept 2014

    2. Main results due

      Feb 2016

    3. Finished

      Feb 2016

    4. Results posted

      Mar 2017

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