Overview

Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.

Status:
Terminated

Trial end date:
2017-01-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Acorda Therapeutics

Treatments:

4-Aminopyridine

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