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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605825
• Other study ID #: DALF-PS-1003
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2012
• Last updated: December 18, 2015
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2015
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Acorda Site #002	Atlantis	Florida
United States	Acorda Site #010	Bellevue	Washington
United States	Acorda Site #011	Birmingham	Alabama
United States	Acorda Site #009	Boston	Massachusetts
United States	Acorda Site #019	Buffalo	New York
United States	Acorda Site #013	Charlotte	North Carolina
United States	Acorda Site #003	Decatur	Georgia
United States	Acorda Site #006	Fairfield	Connecticut
United States	Acorda Site #015	Fort Lauderdale	Florida
United States	Acorda Site #020	Great Falls	Montana
United States	Acorda Site #018	La Jolla	California
United States	Acorda Site #021	Lexington	Kentucky
United States	Acorda Site #022	New Brunswick	New Jersey
United States	Acorda Site #016	Newport Beach	California
United States	Acorda Site #008	Norfolk	Virginia
United States	Acorda Site #001	Philadelphia	Pennsylvania
United States	Acorda Site #023	Reno	Nevada
United States	Acorda Site #017	Saginaw	Michigan
United States	Acorda Site #007	West Haverstraw	New York
United States	Acorda Site #004	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)		Screening visit, Days 1, 8, 15, 22, 29 and 36	No
Other	Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)		Screening visit, Days 1, 8, 15, 22, 29, and 36	No
Other	Manual Dexterity as Measured by the Box and Block Test		Days 1, 8, 15, 22, 29, and 36	No
Other	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
Other	Subject Global Impression (SGI) Scale		Days 8, 15, 22, 29 and 36	No
Other	Clinician Global Impression (CGI) Scale		Days 8, 15, 22, 29 and 36	No
Other	Hand Strength as Measured by the Grip Test and Pinch Tests		Days 1, 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)	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	up to 36 days	No