Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome
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|ClinicalTrials.gov Identifier: NCT02141035|
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : October 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome Compression Neuropathy||Drug: Acetyl-l-carnitine Drug: placebo||Phase 2 Phase 3|
Trial Conduct: This study will be conducted in compliance with the protocol approved by both the University of Alberta Health Research Ethics Board (HREB) and Health Canada. The study will be carried out according to Good Clinical Practice standards. No deviation from the protocol will occur once approved, unless the protocol has put patients at risk. If deviation needs to occur, both HREB and Health Canada will be notified. Written amendments will be submitted to both HREB and Health Canada for their approval.
Population Adult patients suffering from severe CTS would be a population of the interest. Severity of CTS is defined by clinical symptoms and electromyography (EMG) results. These patients will then be recruited for baseline studies, motor unit number estimation (MUNE). Motor unit number estimation is an EMG technique that quantifies the amount of motor units a muscle contains. In various forms of neuropathies, the MUNE decreases. For our study, patients will be included only if their MUNE is 2 standard deviations below normal. These patients will be identified from referrals to plastic surgery clinics or EMG clinics for management.Pre-study Screening and Baseline Evaluation The subject will have a complete physical exam including clinical labs and an ECG. Only those who have normal laboratory and ECG findings will be enrolled in the study.
Randomization Randomization - After enrollment, patients will be randomized to placebo or acetyl-l-carnitine. A statistician will be employed to develop a randomization sequence. Randomization will be kept on a computer under password encryption. The randomization sequence will only be broken if an adverse event occurs to a patient. At the end of the study the statistician will provide the research team with the randomization sequence codes.
Blinding - The study will be administered in a double-blind manner. The randomization sequence will be kept confidential and only accessible to authorized personnel. Pharmacy will distribute identical pills labelled in bottles with A or B. The research team will be unaware of which contains the study drug or placebo. This will be maintained until the final follow-up has occurred when the research team will be unblinded.
Duration The duration of the study is approximately 13 months for each patient. Screening and baseline evaluation will occur within 1 month preoperatively. The investigators will review and document the screening laboratory tests and ECG results. Acetyl-l-carnitine regimen will begin immediately following surgery. This will be continued for 2 months duration. The patient will then complete follow-up visits at 1, 2, 3, 6, and 12 month intervals. At some of those visits, safety monitoring will include periodic blood chemistries, vital signs and evaluation of overall clinical condition (details shown in table above). All clinically relevant changes occurring during the study will be examined and documented. In cases where laboratory abnormalities are detected, appropriate medical management and advice will be provided.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome; a Randomized Control Trial.|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||September 2017|
Acetyl-l-carnitine will be administered for 2 months duration at a dosage of 3000 mg/d starting at the time of decompression surgery.
Those randomized to the treatment arm will receive the medication at 1 g tid for 60 days
Placebo Comparator: Placebo
Placebo will be given for 2 months starting at the time of decompression surgery
The control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days
- Change in motor unit number estimates [ Time Frame: Baseline, 3, 6, and 12 months ]An electromyography technique used to quantify the number of motor units in a motor nerve.
- Change in two point discrimination [ Time Frame: Baseline, 3, 6, and 12 months ]Measurement of spatial determination
- Change in pressure sensitivity using Semmes-Weinstein Monofilaments [ Time Frame: Baseline, 3, 6, and 12 months ]Measurement of pressure sensitivity
- Change in cold detection threshold [ Time Frame: Baseline, 3, 6, and 12 months ]
- Change in pain detection thresholds [ Time Frame: Baseline, 3, 6, and 12 months ]Quantitative measurements of pain thresholds
- Change in hand dexterity using the Purdue Pegboard [ Time Frame: Baseline, 3, 6, and 12 months ]Measurement of hand dexterity
- Change in disability scores using the Disability of Arm, Shoulder and Hand questionnaire [ Time Frame: Baseline, 3, 6, and 12 months ]Validated questionnaire for functionality in carpal tunnel syndrome
- Change in hand symptoms using the Levine questionnaire for carpal tunnel syndrome [ Time Frame: Baseline, 3, 6, and 12 months ]Validated questionnaire for functionality in carpal tunnel syndrome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141035
|Edmonton, Alberta, Canada, T5G 0B7|
|Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T5H 3V9|
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T5R2E1|
|Principal Investigator:||Ming Chan, MB,ChB||Professor, University of Alberta|