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4-AP Peripheral Nerve Crossover Trial

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Phase: Phase 3 to Phase 2
    • Start date changed from estimate of Apr 1, 2025 to Apr 21, 2025
    • Eligibility criteria shortened, about 36 words
    • Study description shortened, about 35 words
    v9
  3. Start date: Mar 1, 2025 to Apr 1, 2025v8
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Feb 1, 2025 to Mar 1, 2025
    v7
  5. Start date: Oct 1, 2024 to Feb 1, 2025v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Dec 2027 to Dec 31, 2027
    • Study completion date: Jul 2028 to Jul 31, 2028
    • Start date: Oct 2024 to Oct 1, 2024
    v5
  2. Start date: Apr 2024 to Oct 2024v4
  3. Study description shortened, about 2 wordsv3
  4. Start date: Oct 2023 to Apr 2024
    • Study description shortened, about 96 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the role of single dose 4-aminopyridine (4-AP) on the diagnosis of severing vs non-severing nerve injury after peripheral nerve traction and/or crush injury. The investigational treatment will be used to test the hypothesis that 4-aminopyridine can speed the determination of nerve continuity after peripheral nerve traction and/or crush injuries allowing the identification of incomplete injuries earlier than standard electrodiagnostic (EDX) and clinical assessment. Participants will be randomized to one of two groups to determine the order of treatment they receive (drug and placebo vs placebo and drug). Participants will undergo baseline testing for nerve assessment, receive either drug or placebo based on randomization and undergo hourly sensory and motor evaluation, EDX testing and serum 4AP levels for three hours after dosing. Participants will then repeat this with the crossover arm.
Trial Details
NCT Number NCT06003166
Lead Sponsor University of Arizona
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Peripheral Nerve Injury, Crush Injury
Related terms Crush Injuries, Peripheral Nerve Injuries
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov