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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
placebo/dalfampridine-ER
dalfampridine-ER/placebo
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Acorda Site #011
  • Acorda Site #018
  • Acorda Site #016
  • Acorda Site #006
  • Acorda Site #002
  • Acorda Site #015
  • Acorda Site #003
  • Acorda Site #021
  • Acorda Site #009
  • Acorda Site #017
  • Acorda Site #020
  • Acorda Site #023
  • Acorda Site #022
  • Acorda Site #019
  • Acorda Site #007
  • Acorda Site #004
  • Acorda Site #013
  • Acorda Site #001
  • Acorda Site #008
  • Acorda Site #010

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

placebo/dalfampridine-ER

dalfampridine-ER/placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)
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

Secondary Outcome Measures

Full Information

First Posted
May 21, 2012
Last Updated
December 18, 2015
Sponsor
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01605825
Brief Title
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
Official Title
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo/dalfampridine-ER
Arm Type
Placebo Comparator
Arm 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 Title
dalfampridine-ER/placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
placebo/dalfampridine-ER
Intervention Description
Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
Intervention Type
Drug
Intervention Name(s)
dalfampridine-ER/placebo
Intervention Description
Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
Primary Outcome Measure Information:
Title
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)
Description
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
Time Frame
up to 36 days
Other Pre-specified Outcome Measures:
Title
Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)
Time Frame
Screening visit, Days 1, 8, 15, 22, 29 and 36
Title
Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)
Time Frame
Screening visit, Days 1, 8, 15, 22, 29, and 36
Title
Manual Dexterity as Measured by the Box and Block Test
Time Frame
Days 1, 8, 15, 22, 29, and 36
Title
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
Title
Subject Global Impression (SGI) Scale
Time Frame
Days 8, 15, 22, 29 and 36
Title
Clinician Global Impression (CGI) Scale
Time Frame
Days 8, 15, 22, 29 and 36
Title
Hand Strength as Measured by the Grip Test and Pinch Tests
Time Frame
Days 1, 8, 15, 22, 29, and 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathews Adera, MD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Acorda Site #011
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Acorda Site #018
City
La Jolla
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Acorda Site #016
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Acorda Site #006
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Acorda Site #002
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Acorda Site #015
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Acorda Site #003
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Acorda Site #021
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Acorda Site #009
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Acorda Site #017
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Acorda Site #020
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Acorda Site #023
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Acorda Site #022
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Acorda Site #019
City
Buffalo
State/Province
New York
ZIP/Postal Code
14220
Country
United States
Facility Name
Acorda Site #007
City
West Haverstraw
State/Province
New York
ZIP/Postal Code
10993
Country
United States
Facility Name
Acorda Site #004
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Acorda Site #013
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Acorda Site #001
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Acorda Site #008
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Acorda Site #010
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23652269
Citation
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.
Results Reference
derived

Learn more about this trial

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

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