CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
Acetyl-l-carnitine +1 moredrug
Likely dose
Acetyl-l-carnitine 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02141035
NCT02141035Phase 3Completed

Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome; a Randomized Control Trial.

University of Alberta·interventional·Posted May 16, 2014·Updated Oct 27, 2017

In Brief

A Phase 3 clinical trial evaluating Acetyl-l-carnitine and placebo for Carpal Tunnel Syndrome and Compression Neuropathy. Completed, enrolled 20 participants across 3 sites.

Detailed Summary

Study Hypothesis: Acetyl-l-carnitine increases nerve regeneration in patients with severe carpal tunnel syndrome. Carpal tunnel syndrome (CTS) is common, affecting almost 3% of the general population. In severe cases, nerve regeneration and functional recovery are incomplete even with surgery. The goal of this pilot project is to test a potentially promising medication, acetyl-l-carnitine (ALCAR). We will use a randomized, double blinded, placebo controlled study design. Along with surgery, those in the treatment group will also receive ALCAR while the other half in the control group will be given placebo. To gauge the effects of ALCAR, we will compare motor and sensory nerve growth as well as functional outcomes. The data from this study will provide crucial information when designing a full scale clinical trial. If successful, this will represent an important first step in finding a novel treatment to improve functional outcomes in patients with severe CTS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 16, 2014
Enrollment StartSep 1, 2015
Primary CompletionJun 1, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.1 years ago

Interventions

Acetyl-l-carnitinedrug

Those randomized to the treatment arm will receive the medication at 1 g tid for 60 days

placebodrug

The control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days