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: April 4, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 21, 2012

Last Updated Date

April 4, 2013

Start Date ^ICMJE

May 2012

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01605825 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Ischemic Stroke

Intervention ^ICMJE

Drug: 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
Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart

Study Arm (s)

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: 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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2013

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01605825

Other Study ID Numbers ^ICMJE

DALF-PS-1003

Has Data Monitoring Committee

Yes

Responsible Party

Acorda Therapeutics

Study Sponsor ^ICMJE

Acorda Therapeutics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Gustavo Suarez, MD

Acorda Therapeutics

Information Provided By

Acorda Therapeutics

Verification Date

April 2013

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

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