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Use of Dalfampridine in Primary Lateral Sclerosis

StatusCompleted
PhasePhase 1
Started
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Record History

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  1. Trial status changed: Unknown → Completed
    • Final enrollment: 26 participants (planned 35)
    • Primary completion date changed from estimate of Jul 2026 to May 2025
    • Eligibility criteria expanded, about 25 words
  2. Changed Registry marked status Unknown; last known: Active, Not Recruiting
  3. Primary and study completion dates: Jul 2025 to Jul 2026v15
  4. Primary and study completion dates: Jul 2024 to Jul 2025v14
  5. Primary and study completion dates: Jul 2023 to Jul 2024v13
Show 11 earlier versionsHide 11 earlier versions
  1. Re-verified, no change to tracked fieldsv12
  2. Primary completion date: Jul 2021 to Jul 2023
    • Study completion date: Jul 2022 to Jul 2023
    v11
  3. Lead sponsor: Weill Medical College of Cornell University to Hospital for Special Surgery, New Yorkv10 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jan 2021 to Jul 2021
    • Study completion date: Sep 2021 to Jul 2022
    • Study sites revised (3)
    • Collaborators shortened, about 6 words
  4. Primary completion date: Jan 2020 to Jan 2021v9 Show 4 more changesShow less
    • Study completion date: Sep 2020 to Sep 2021
    • Eligibility criteria revised
    • Study sites revised (3)
    • Study title revised
  5. Site contacts updated at 1 of 3 sitesv8
  6. Eligibility criteria shortened, about 69 wordsv7
  7. Primary completion date: Jan 2019 to Jan 2020
    • Study completion date: Jan 2019 to Sep 2020
    v6
  8. Study sites: 1 to 3v5
  9. Primary completion date: Mar 2018 to Jan 2019
    • Study completion date: Jan 2019
    • Eligibility criteria revised
    v4
  10. Secondary endpoints: 1 to 5v3
  11. Study sites: 2 to 1
    • Eligibility criteria expanded, about 37 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Walk while on medication, compared with the baseline results while off medication.
Trial Details
NCT Number NCT02868567
Lead Sponsor Hospital for Special Surgery, New York
Conditions
(from sponsor)		 Motor Neuron Disease, Upper
Related terms Motor Neuron Disease
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov