4AP for Carpal Tunnel Syndrome (CTS)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorJohn Elfar
About this trial
The investigators have found recent promising data supporting the use of a currently FDA approved drug, 4-aminopyridine, in the treatment of nerve injury including compression neuropathy. The purpose of this research is determine whether 4-aminopyridine can treat carpal tunnel syndrome or delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with non-traumatic carpal tunnel syndrome without any other confounding diagnosis (e.g. cubital tunnel syndrome, cervical nerve compression)
Standard of care EDX testing within 6 months of study enrollment
Cognitive ability to report sensory and motor deficit during examination.
Able to complete twice daily dosing of 4-AP for the entire 6 week treatment period.
Disqualifiers
Inability to complete twice daily dosing during 6 week treatment period.
History of multiple sclerosis, stroke or any other diagnosed neurological disorder
History of hypersensitivity to AMPYRA® or 4-aminopyridine
Current use of aminopyridine medications, including other compounded 4-AP
Trial design
Design model
Parallel
Treatments tested in this trial
4-Aminopyridine
DrugSubjects will receive either the active study drug (4-aminopyridine) or placebo to determine the effects of 4AP on carpal tunnel syndrome
Placebo
Other interventionSubjects will receive either the active study drug (4-aminopyridine) or placebo to determine the effects of 4AP on carpal tunnel syndrome
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: 4-aminopyridineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Results of symptomatic improvement in the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Improvement of Carpal Tunnel Syndrome symptoms will be measured using the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) - a validated patient reported outcome measure. The scale contains 6 items on the severity and frequency of night and daytime numbness, tingling and pain. Each item is scored on a 5-point Likert scale from 1 (no symptoms) to 5 (most severe symptoms). Subjects will complete a baseline questionnaire prior to treatment initiation. The questionnaire will be completed all study visit following initiation of treatment until the final study visit at 56 weeks post treatment.
Time frame
Baseline (prior to study treatment) to 56 weeks post treatment2
Results of symptomatic improvement in the Michigan Hand Outcomes Questionnaire (MHQ)
Improvement of Carpal Tunnel Syndrome symptoms will be measured with standardized validated outcomes measure, the Michigan Hand Outcomes Questionnaire (MHQ) for improvement in carpal tunnel symptomatology. The MHQ is a tool used to assess patients with hand disorders through the measurement of 6 health domains: overall hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. Baseline measures will be completed prior to treatment and repeated at each study visit with the final outcome questionnaire completed at the final, 56 week visit.
Time frame
Baseline (prior to study treatment) to 56 weeks post treatment.Secondary outcomes
1
Electrodiagnostic improvement following treatment
Nerve conduction velocity improvement \> 10% compared to pre-treatment nerve conduction velocity. Electrodiagnostic studies will be completed as part of standard of care prior to initiation of treatment and repeated at 8 weeks post treatment.
Time frame
Baseline (prior to study treatment) and 8 weeks post treatment.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
John Elfar
Lead sponsor
University of Arizona
Sponsor institution
Source ClinicalTrials.gov
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