Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.
Status: | Terminated |
---|---|
Conditions: | Peripheral Vascular Disease, Neurology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/23/2019 |
Start Date: | April 2015 |
End Date: | January 2017 |
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 .
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of
two dose strengths of dalfampridine-ER.
two dose strengths of dalfampridine-ER.
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.
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.
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
We found this trial at
60
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials