A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

Completed

Phase 2 Results

Trial Description

This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.

Conditions

Interventions

  • Dalfampridine-ER Drug
    Intervention Desc: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
    ARM 1: Kind: Experimental
    Label: placebo/dalfampridine-ER
    Description: Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
    ARM 2: Kind: Experimental
    Label: dalfampridine-ER/placebo
    Description: Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
  • Placebo/dalfampridine-ER Drug
    Intervention Desc: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
    ARM 1: Kind: Experimental
    Label: placebo/dalfampridine-ER
    Description: Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
  • Dalfampridine-ER/placebo Drug
    Intervention Desc: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
    ARM 1: Kind: Experimental
    Label: dalfampridine-ER/placebo
    Description: Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety and tolerability of dalfampridine-ER in subjects with chronic deficits after ischemic stroke 38 days (days 1, 8, 15, 22, 29, and 36) No
Secondary Change in walking speed measured by the Timed 25 Foot Walk test (T25FW) Days 8, 15, 22, 29 and 36 compared to day 1 No
Secondary Motor and sensory function as measured by the Fugl-Meyer Assessment (FMA) Screening visit, Days 1, 8, 15, 22, 29, and 36 No
Secondary Manual dexterity as measured by the Box and Block Test Days 1, 8, 15, 22, 29, and 36 No
Secondary Assistance required to perform activities of daily living (ADL) by the Functional Independence Measure (FIM) scale Days 1, 8, 15, 22, 29, and 36 No
Secondary Subject Global Impression (SGI) scale Days 8, 15, 22, 29 and 36 No
Secondary Clinician Global Impression (CGI) scale Days 8, 15, 22, 29 and 36 No
Primary Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) up to 36 days No

Sponsors