Clinical Trial: Use of Dalfampridin in Primary Lateral Sclerosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, 18-week Open Label Safety and Efficacy Trial of Dalfampridine in Primary Lateral Sclerosis

Brief Summary: This study will comprise an 18-week open label safety and tolerability trial. In this study, a total of 35 subjects with primary lateral sclerosis PLS or upper motor neuron predominate ALS will be enrolled. At the initial screening evaluation, a baseline T25FW will be obtained. This baseline test will be repeated at weeks 2, 4, 6, 10, 14 18. The validity of this measure was shown in MS studies when compared to the MSWS-12 (12 item walking scale) and CGI (clinical global impression) scales (35-37). A consistent responder will be defined as improvement in 3 of 4 Timed 25Foot Wwalk while on medication, compared with the baseline results while off medication.

Detailed Summary:
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: consistent improvement in the Timed 25 Foot Walk test [ Time Frame: over the duration of the study at week 2, 4, 6, 10, 14, 18 ]

speed of walking 25 feet


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of Dalfampridine on quality of life [ Time Frame: over the course of study at weeks 2, 4, 6, 10, 14, 18 ]
    ALSFRS-R,
  • Effects of Dalfampridine on functional status [ Time Frame: over the course of study at weeks 2, 4, 6, 10, 14, 18 ]
    MSWS-12
  • Effects of Dalfampridine on functional status [ Time Frame: over the course of study at weeks 2, 4, 6, 10, 14, 18 ]
    CGI, SGI
  • Effects of Dalfampridine on functional status [ Time Frame: over the course of study at weeks 2, 4, 6, 10, 14, 18 ]
    2MW, TUG
  • Effects of Dalfampridine on functional status [ Time Frame: over the course of study at weeks 2, 4, 6, 10, 14, 18 ]
    PPT, Hand and Foot tapping.


Original Secondary Outcome: Effect of Dalfampridine on quality of life [ Time Frame: over the course of study as weeks 2, 4, 6, 10, 14, 18 ]

McGill 1 point quality of life scale


Information By: Weill Medical College of Cornell University

Dates:
Date Received: March 17, 2016
Date Started: March 2016
Date Completion:
Last Updated: November 4, 2016
Last Verified: November 2016