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

NCT02141035 | Completed Phase 2

• 2 other identifiers: Pro00045538RES0021133
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Acetyl-l-carnitine; Carpal tunnel syndrome; Motor unit number estimation; Compression neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in motor unit number estimates

  An electromyography technique used to quantify the number of motor units in a motor nerve.

  Baseline, 3, 6, and 12 months

Secondary Outcomes (7)

• Change in two point discrimination

  Baseline, 3, 6, and 12 months

• Change in pressure sensitivity using Semmes-Weinstein Monofilaments

  Baseline, 3, 6, and 12 months

• Change in cold detection threshold

  Baseline, 3, 6, and 12 months

• Change in pain detection thresholds

  Baseline, 3, 6, and 12 months

• Change in hand dexterity using the Purdue Pegboard

  Baseline, 3, 6, and 12 months

Study Arms (2)

Acetyl-l-carnitine

EXPERIMENTAL

Acetyl-l-carnitine will be administered for 2 months duration at a dosage of 3000 mg/d starting at the time of decompression surgery.

Drug: Acetyl-l-carnitine

Placebo

PLACEBO COMPARATOR

Placebo will be given for 2 months starting at the time of decompression surgery

Drug: placebo

Interventions

Acetyl-l-carnitine DRUG

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

Acetyl-l-carnitine

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• numbness and parenthesis in the median nerve distribution;
• Precipitation of those symptoms by repetitive motions that are relieved by rubbing and or shaking the hands;
• Nocturnal awakening by those sensory symptoms, or
• Weakness of thumb abduction and thenar atrophy.

You may not qualify if:

• Motor unit loss in the median nerve less than 2 SD below the mean for the age as determined by nerve conduction studies.
• The presence of other neurologic conditions
• Previous carpal tunnel release surgery
• Cognitive impairment that renders the patient unable to provide informed consent;
• Pregnancy

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (3)

Glenrose Hosptial

Edmonton, Alberta, T5G 0B7, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T5R2E1, Canada

Location

Related Publications (26)

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  PMID: 10411196 RESULT

• Curran MW, Olson J, Morhart M, Sample D, Chan KM. Acetyl-L-carnitine (ALCAR) to enhance nerve regeneration in carpal tunnel syndrome: study protocol for a randomized, placebo-controlled trial. Trials. 2016 Apr 14;17:200. doi: 10.1186/s13063-016-1324-2.

  PMID: 27079660 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Tomaculous neuropathy

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Ming Chan, MB,ChB

  Professor, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 16, 2014
• Study Start: September 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

CA (3)