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A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets. (MILESTONE℠)

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ClinicalTrials.gov Identifier: NCT02271217
Recruitment Status : Completed
First Posted : October 22, 2014
Results First Posted : December 4, 2017
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Post-Ischemic Stroke Drug: Placebo Drug: dalfampridine-ER 7.5mg Drug: dalfampridine-ER 10mg Phase 3

Detailed Description:
This was a randomized, placebo-controlled, three-arm, parallel-group study designed to evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER) tablets on chronic walking deficits in subjects with post-ischemic stroke.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : December 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
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.
Drug: Placebo
Active Comparator: dalfampridine-ER 7.5 mg
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.
Drug: dalfampridine-ER 7.5mg
Active Comparator: dalfampridine-ER 10mg
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.
Drug: dalfampridine-ER 10mg
Other Name: Ampyra




Primary Outcome Measures :
  1. Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12 [ Time Frame: Week 12 ]
    "The 2MinWT measures the distance a subject can walk in 2 minutes. Participants showing at Least a 20% Improvement on the 2MinWT at 12-weeks are considered "Responders".


Secondary Outcome Measures :
  1. Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary) [ Time Frame: Baseline, week 12 ]

    The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility.

    Walk-12 Score = 100 * [(Mean of the 12 items) - 1]/(5-1)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271217


Locations
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Sponsors and Collaborators
Acorda Therapeutics
Investigators
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Study Director: Holly Roberts, MD Acorda Therapeutics
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02271217    
Other Study ID Numbers: DALF-PS-1016
First Posted: October 22, 2014    Key Record Dates
Results First Posted: December 4, 2017
Last Update Posted: June 7, 2018
Last Verified: September 2017
Keywords provided by Acorda Therapeutics:
Post stroke
Ischemic stroke
Additional relevant MeSH terms:
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Ischemic Stroke
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action