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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01605825
First received: May 21, 2012
Last updated: March 12, 2014
Last verified: March 2014

May 21, 2012
March 12, 2014
May 2012
February 2013   (final data collection date for primary outcome measure)
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: up to 36 days ] [ Designated as safety issue: No ]

A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment.

The severity categories of mild, moderate or severe, are defined below:

  • Mild is defined as causing no limitation of usual activities
  • Moderate is defined as causing some limitation of usual activities
  • Severe is defined as causing inability to carry out usual activities
Safety and tolerability of dalfampridine-ER in subjects with chronic deficits after ischemic stroke [ Time Frame: 38 days (days 1, 8, 15, 22, 29, and 36) ] [ Designated as safety issue: No ]
Safety and tolerability will be assessed by reviewing the rate of adverse events. Changes in vital signs and laboratory test results compared to baseline using descriptive statistics
Complete list of historical versions of study NCT01605825 on ClinicalTrials.gov Archive Site
Not Provided
  • Change in walking speed measured by the Timed 25 Foot Walk test (T25FW) [ Time Frame: Days 8, 15, 22, 29 and 36 compared to day 1 ] [ Designated as safety issue: No ]
  • Motor and sensory function as measured by the Fugl-Meyer Assessment (FMA) [ Time Frame: Screening visit, Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
  • Manual dexterity as measured by the Box and Block Test [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
  • Assistance required to perform activities of daily living (ADL) by the Functional Independence Measure (FIM) scale [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
  • Subject Global Impression (SGI) scale [ Time Frame: Days 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]
  • Clinician Global Impression (CGI) scale [ Time Frame: Days 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]
  • Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW) [ Time Frame: Screening visit, Days 1, 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]
  • Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA) [ Time Frame: Screening visit, Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
  • Manual Dexterity as Measured by the Box and Block Test [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
  • Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
  • Subject Global Impression (SGI) Scale [ Time Frame: Days 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]
  • Clinician Global Impression (CGI) Scale [ Time Frame: Days 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]
  • Hand Strength as Measured by the Grip Test and Pinch Tests [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
Not Provided
 
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: placebo/dalfampridine-ER
    Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
  • Drug: dalfampridine-ER/placebo
    Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
  • Placebo Comparator: placebo/dalfampridine-ER

    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

    Intervention: Drug: placebo/dalfampridine-ER
  • Placebo Comparator: dalfampridine-ER/placebo

    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

    Intervention: Drug: dalfampridine-ER/placebo
Iaci JF, Parry TJ, Huang Z, Finklestein SP, Ren J, Barrile DK, Davenport MD, Wu R, Blight AR, Caggiano AO. Dalfampridine improves sensorimotor function in rats with chronic deficits after middle cerebral artery occlusion. Stroke. 2013 Jul;44(7):1942-50. doi: 10.1161/STROKEAHA.111.000147. Epub 2013 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
March 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by the Investigator with supportive prior imaging findings (MRI/ CT scan)
  • ≥ 6 months post-stroke
  • Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive
  • Stable concomitant medication therapy regimen within 4 weeks of screening visit

Exclusion Criteria:

  • History of seizures, except simple febrile seizures
  • Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
  • Botulinum toxin use within 2 months prior to the Screening Visit
  • Orthopedic surgical procedures in any of the extremities within the past 6 months
  • Diagnosis of multiple sclerosis
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01605825
DALF-PS-1003
Yes
Acorda Therapeutics
Acorda Therapeutics
Not Provided
Study Director: Mathews Adera, MD Acorda Therapeutics
Acorda Therapeutics
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP