Trial record 11 of 42 for:    Acorda

An Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine Extended-Release Tablets for the Treatment of Chronic Post-Ischemic Stroke Walking Deficits in Subjects Who Participated in the DALF-PS-1016 Study (MILESTONE℠)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Acorda Therapeutics
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT02422940
First received: April 14, 2015
Last updated: April 17, 2015
Last verified: April 2015
  Purpose

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12 months to subjects with chronic post-ischemic stroke walking deficits who have completed the controlled, double-blind Study DALF-PS-1016.


Condition Intervention Phase
Post-ischemic Stroke
Drug: dalfampridine-ER 7.5 mg
Drug: dalfampridine-ER 10 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Number of participants with Serious and Non-Serious Adverse Events (AEs) as a measure of Safety and Tolerability [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline on the Two-Minute Walk Test (2MinWT) [ Time Frame: Day 1, up to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline on the 10 Meter Walk Test (10MWT) [ Time Frame: Day 1, up to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline on the Timed up and Go (TUG) Test [ Time Frame: Day 1, up to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline on the Walking Impact Scale (Walk-12) [ Time Frame: Day 1, up to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline on the Stroke Impact Scale (SIS) [ Time Frame: Day 1, up to 12 months ] [ Designated as safety issue: No ]
  • Subject Global Impression (SGI) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Change from baseline on the 12-item health survey (SF-12) [ Time Frame: Day 1, up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dalfampridine-ER 7.5 mg

Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.

Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.

Drug: dalfampridine-ER 7.5 mg
Active Comparator: dalfampridine-ER 10 mg

Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.

Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.

Drug: dalfampridine-ER 10 mg
Other Name: Ampyra™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Completion of the DALF-PS-1016 study
  • Providing informed consent to continue into the DALF-PS-1029 long-term extension study
  • Sufficient ambulatory ability to independently complete the Two Minute Walk Test (2MinWT) and 10 Meter Walk Test (10MWT) at the time of enrollment into the extension study

Key Exclusion Criteria:

  • Seizures, new onset strokes (or other significant neurological event precluding long-term continuation) occurring during the antecedent DALF-PS-1016 study
  • Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the long-term extension study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02422940

Locations
United States, Florida
Acorda Investigational Site Recruiting
Atlantis, Florida, United States, 33462
Contact: Janette Bossaers    561-968-2933      
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Holly Roberts, MD Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02422940     History of Changes
Other Study ID Numbers: DALF-PS-1029
Study First Received: April 14, 2015
Last Updated: April 17, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
4-Aminopyridine
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Potassium Channel Blockers
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015