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.
