Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine. (MILESTONE℠)

Acorda Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Post-ischemic Stroke

Treatments: Drug: dalfampridine-ER 7.5 mg; Drug: dalfampridine-ER 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02422940

DALF-PS-1029

Details and patient eligibility

About

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.

Full description

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.

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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294 participants in 2 patient groups

dalfampridine-ER 7.5 mg

Active Comparator group

Description:

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.

Treatment:

Drug: dalfampridine-ER 7.5 mg

dalfampridine-ER 10 mg

Active Comparator group

Description:

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.

Treatment:

Drug: dalfampridine-ER 10 mg