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Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome

NCT02141035 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-10-27

No results posted yet for this study

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.

Conditions

  • Carpal Tunnel Syndrome
  • Compression Neuropathy

Interventions

DRUG

Acetyl-l-carnitine

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

DRUG

placebo

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

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Ming Chan, MB,ChB · Professor, University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141035 on ClinicalTrials.gov