Overview

This trial has been completed.

Condition post-ischemic stroke
Treatments placebo, dalfampridine-er 7.5mg, dalfampridine-er 10mg
Phase phase 3
Sponsor Acorda Therapeutics
Start date December 2014
End date September 2016
Trial size 377 participants
Trial identifier NCT02271217, DALF-PS-1016

Summary

The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
placebo
(Active Comparator)
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-er 7.5mg
(Active Comparator)
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-er 10mg Ampyra

Primary Outcomes

Measure
Proportion of subjects who show at least a 20% improvement on the Two Minute Walk Test (2MinWT) at week 12
time frame: Week 12

Secondary Outcomes

Measure
Change from baseline on the Walking Impact Scale (Walk-12) at week 12 (key secondary)
time frame: Baseline, week 12
Proportion of subjects who show at least a 20% improvement on the 2MinWT
time frame: Baseline, weeks 2,4,8, double-blind average and the follow-up visits at weeks 14 and 16
Change from baseline on the 2MinWT
time frame: Baseline, weeks 2,4,8,12, double-blind average and the follow-up visits at weeks 14 and 16
Change from baseline on the Walk-12
time frame: Baseline, weeks 2,4,8, double-blind average and the follow-up visits at weeks 14 and 16
Change from baseline on the 10 Meter Walk Test (10MWT)
time frame: Baseline, weeks 2,4,8,12, double-blind average and the follow-up visits at weeks 14 and 16
Change from baseline on the Timed Up and Go Test (TUG)
time frame: Baseline, weeks 2,4,8,12, double-blind average and the follow-up visits at weeks 14 and 16
Change from baseline on the Stroke Impact Scale (SIS)
time frame: Baseline, weeks 2,4,8,12, double-blind average and the follow-up visits at weeks 14 and 16
Change from baseline on the 12-item Health Survey (SF-12)
time frame: Baseline, week 12
Shift in projected community ambulation based on the 10MWT
time frame: Baseline, week 12
Number of participants with Serious and Non-Serious Adverse Events (AEs)
time frame: Up to 20 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator, based on review of medical records and physical exam. Such deficit was not present prior to the stroke and cannot be attributed primarily to other conditions (e.g. chronic obstructive pulmonary disease, arthritis). Evidence of walking deficits is objectively supported by any one of the following findings on clinical examination: 1. obvious slowness of movement assigned primarily to the stroke 2. use of an assistive walking device such as a cane or walker 3. Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip hiking and hip circumduction - Modified Rankin Scale score of 1 - 3, regardless of the cause(s) of the disability - Sufficient ambulatory ability to independently complete the 2MinWT and 10MWT - ≥ 6 months from occurrence of most recent stroke Exclusion Criteria: - Woman who is not surgically sterile or is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product. - Woman who is pregnant, breastfeeding, or planning to become pregnant - 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 - Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal ideation within 6 months prior to the Screening Visit, or subject is at significant risk of suicidal behavior in the opinion of the Investigator - Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP) - Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the Screening Visit, or any change in dosing regimen within 3 months prior to the Screening Visit - Botulinum toxin use within 2 months prior to the Screening Visit - Orthopedic surgical procedures in any of the extremities within the past 6 months

Additional Information

Official title This is a Multi-center, Double-blind, Three Arm, Parallel Group, Placebo-controlled, Randomized Study Designed to Evaluate the Efficacy, Safety and Tolerability of Dalfampridine-ER Tablets for Treatment of Stable Walking Deficits in Subjects With Post-ischemic Stroke.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Acorda Therapeutics.