Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-28 @ 2:59 AM
Study NCT ID:
NCT02141035
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2014-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'C536965', 'term': 'Tomaculous neuropathy'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000108', 'term': 'Acetylcarnitine'}], 'ancestors': [{'id': 'D002331', 'term': 'Carnitine'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-25', 'studyFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2014-05-14', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in motor unit number estimates', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'An electromyography technique used to quantify the number of motor units in a motor nerve.'}], 'secondaryOutcomes': [{'measure': 'Change in two point discrimination', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measurement of spatial determination'}, {'measure': 'Change in pressure sensitivity using Semmes-Weinstein Monofilaments', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measurement of pressure sensitivity'}, {'measure': 'Change in cold detection threshold', 'timeFrame': 'Baseline, 3, 6, and 12 months'}, {'measure': 'Change in pain detection thresholds', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Quantitative measurements of pain thresholds'}, {'measure': 'Change in hand dexterity using the Purdue Pegboard', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measurement of hand dexterity'}, {'measure': 'Change in disability scores using the Disability of Arm, Shoulder and Hand questionnaire', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Validated questionnaire for functionality in carpal tunnel syndrome'}, {'measure': 'Change in hand symptoms using the Levine questionnaire for carpal tunnel syndrome', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Validated questionnaire for functionality in carpal tunnel syndrome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acetyl-l-carnitine', 'Carpal tunnel syndrome', 'Motor unit number estimation', 'Compression neuropathy'], 'conditions': ['Carpal Tunnel Syndrome', 'Compression Neuropathy']}, 'referencesModule': {'references': [{'pmid': '12877853', 'type': 'BACKGROUND', 'citation': 'Atroshi I, Gummesson C, Johnsson R, McCabe SJ, Ornstein E. Severe carpal tunnel syndrome potentially needing surgical treatment in a general population. J Hand Surg Am. 2003 Jul;28(4):639-44. doi: 10.1016/s0363-5023(03)00148-5.'}, {'pmid': '18500755', 'type': 'BACKGROUND', 'citation': 'Barhwal K, Hota SK, Prasad D, Singh SB, Ilavazhagan G. Hypoxia-induced deactivation of NGF-mediated ERK1/2 signaling in hippocampal cells: neuroprotection by acetyl-L-carnitine. J Neurosci Res. 2008 Sep;86(12):2705-21. doi: 10.1002/jnr.21722.'}, {'pmid': '16039110', 'type': 'BACKGROUND', 'citation': 'Bianchi G, Vitali G, Caraceni A, Ravaglia S, Capri G, Cundari S, Zanna C, Gianni L. Symptomatic and neurophysiological responses of paclitaxel- or cisplatin-induced neuropathy to oral acetyl-L-carnitine. Eur J Cancer. 2005 Aug;41(12):1746-50. doi: 10.1016/j.ejca.2005.04.028.'}, {'pmid': '11932599', 'type': 'BACKGROUND', 'citation': 'Bitar G, Alexandrides J, Missirian R, Sotereanos D, Nystrom A. Carpal tunnel release in the United States and Sweden: reimbursement patterns, cost for treatment, and return to work. Plast Reconstr Surg. 2002 Apr 15;109(5):1574-8; discussion 1579-80. doi: 10.1097/00006534-200204150-00013.'}, {'pmid': '12845152', 'type': 'BACKGROUND', 'citation': 'Boyd JG, Gordon T. Neurotrophic factors and their receptors in axonal regeneration and functional recovery after peripheral nerve injury. Mol Neurobiol. 2003 Jun;27(3):277-324. doi: 10.1385/MN:27:3:277.'}, {'pmid': '8260833', 'type': 'BACKGROUND', 'citation': 'Bunge RP. Expanding roles for the Schwann cell: ensheathment, myelination, trophism and regeneration. Curr Opin Neurobiol. 1993 Oct;3(5):805-9. doi: 10.1016/0959-4388(93)90157-t.'}, {'pmid': '16042313', 'type': 'BACKGROUND', 'citation': 'Chen YY, McDonald D, Cheng C, Magnowski B, Durand J, Zochodne DW. Axon and Schwann cell partnership during nerve regrowth. J Neuropathol Exp Neurol. 2005 Jul;64(7):613-22. doi: 10.1097/01.jnen.0000171650.94341.46.'}, {'pmid': '18370471', 'type': 'BACKGROUND', 'citation': 'Grandis DD. Tolerability and efficacy of L-acetylcarnitine in patients with peripheral neuropathies: a short-term, open multicentre study. Clin Drug Investig. 1998;15(2):73-9. doi: 10.2165/00044011-199815020-00001.'}, {'pmid': '12455197', 'type': 'BACKGROUND', 'citation': 'De Grandis D, Minardi C. Acetyl-L-carnitine (levacecarnine) in the treatment of diabetic neuropathy. A long-term, randomised, double-blind, placebo-controlled study. Drugs R D. 2002;3(4):223-31. doi: 10.2165/00126839-200203040-00001.'}, {'pmid': '9005851', 'type': 'BACKGROUND', 'citation': 'Dudek H, Datta SR, Franke TF, Birnbaum MJ, Yao R, Cooper GM, Segal RA, Kaplan DR, Greenberg ME. Regulation of neuronal survival by the serine-threonine protein kinase Akt. Science. 1997 Jan 31;275(5300):661-5. doi: 10.1126/science.275.5300.661.'}, {'pmid': '18940920', 'type': 'BACKGROUND', 'citation': 'Evans JD, Jacobs TF, Evans EW. Role of acetyl-L-carnitine in the treatment of diabetic peripheral neuropathy. Ann Pharmacother. 2008 Nov;42(11):1686-91. doi: 10.1345/aph.1L201. Epub 2008 Oct 21.'}, {'pmid': '7751953', 'type': 'BACKGROUND', 'citation': 'Fu SY, Gordon T. Contributing factors to poor functional recovery after delayed nerve repair: prolonged denervation. J Neurosci. 1995 May;15(5 Pt 2):3886-95. doi: 10.1523/JNEUROSCI.15-05-03886.1995.'}, {'pmid': '19800329', 'type': 'BACKGROUND', 'citation': 'Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol. 2010 May;223(1):192-202. doi: 10.1016/j.expneurol.2009.09.020. Epub 2009 Oct 1.'}, {'type': 'BACKGROUND', 'citation': 'Gutmann E, Guttmann L, Medawar PB, & Young JZ (1942). The rate of regeneration of nerve. J Exp Biol 19, 14-44.'}, {'pmid': '10586247', 'type': 'BACKGROUND', 'citation': 'Hall SM. The biology of chronically denervated Schwann cells. Ann N Y Acad Sci. 1999 Sep 14;883:215-33.'}, {'pmid': '12453625', 'type': 'BACKGROUND', 'citation': 'McKay Hart A, Wiberg M, Terenghi G. Pharmacological enhancement of peripheral nerve regeneration in the rat by systemic acetyl-L-carnitine treatment. Neurosci Lett. 2002 Dec 16;334(3):181-5. doi: 10.1016/s0304-3940(02)00982-5.'}, {'pmid': '10851172', 'type': 'BACKGROUND', 'citation': 'Kaplan DR, Miller FD. Neurotrophin signal transduction in the nervous system. Curr Opin Neurobiol. 2000 Jun;10(3):381-91. doi: 10.1016/s0959-4388(00)00092-1.'}, {'pmid': '17935020', 'type': 'BACKGROUND', 'citation': 'Kotil K, Kirali M, Eras M, Bilge T, Uzun H. Neuroprotective effects of acetyl-L-carnithine in experimental chronic compression neuropathy. A prospective, randomized and placebo-control trials. Turk Neurosurg. 2007 Apr;17(2):67-77.'}, {'pmid': '10559381', 'type': 'BACKGROUND', 'citation': 'Mazzoni IE, Said FA, Aloyz R, Miller FD, Kaplan D. Ras regulates sympathetic neuron survival by suppressing the p53-mediated cell death pathway. J Neurosci. 1999 Nov 15;19(22):9716-27. doi: 10.1523/JNEUROSCI.19-22-09716.1999.'}, {'pmid': '11102965', 'type': 'BACKGROUND', 'citation': 'Sulaiman OA, Gordon T. Effects of short- and long-term Schwann cell denervation on peripheral nerve regeneration, myelination, and size. Glia. 2000 Dec;32(3):234-46. doi: 10.1002/1098-1136(200012)32:33.0.co;2-3.'}, {'pmid': '20265595', 'type': 'BACKGROUND', 'citation': 'SUNDERLAND S. Rate of regeneration in human peripheral nerves; analysis of the interval between injury and onset of recovery. Arch Neurol Psychiatry. 1947 Sep;58(3):251-95. doi: 10.1001/archneurpsyc.1947.02300320002001. No abstract available.'}, {'pmid': '14615246', 'type': 'BACKGROUND', 'citation': 'Wilson AD, Hart A, Brannstrom T, Wiberg M, Terenghi G. Primary sensory neuronal rescue with systemic acetyl-L-carnitine following peripheral axotomy. A dose-response analysis. Br J Plast Surg. 2003 Dec;56(8):732-9. doi: 10.1016/j.bjps.2003.08.005.'}, {'pmid': '9179594', 'type': 'BACKGROUND', 'citation': 'You S, Petrov T, Chung PH, Gordon T. The expression of the low affinity nerve growth factor receptor in long-term denervated Schwann cells. Glia. 1997 Jun;20(2):87-100. doi: 10.1002/(sici)1098-1136(199706)20:23.0.co;2-1.'}, {'pmid': '17461852', 'type': 'BACKGROUND', 'citation': 'Youle M, Osio M; ALCAR Study Group. A double-blind, parallel-group, placebo-controlled, multicentre study of acetyl L-carnitine in the symptomatic treatment of antiretroviral toxic neuropathy in patients with HIV-1 infection. HIV Med. 2007 May;8(4):241-50. doi: 10.1111/j.1468-1293.2007.00467.x.'}, {'pmid': '10411196', 'type': 'RESULT', 'citation': 'Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8. doi: 10.1001/jama.282.2.153.'}, {'pmid': '27079660', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Study Hypothesis: Acetyl-l-carnitine increases nerve regeneration in patients with severe carpal tunnel syndrome.\n\nCarpal 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.', 'detailedDescription': '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.\n\nPopulation 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.\n\nRandomization 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.\n\nBlinding - 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.\n\nDuration 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be recruited from the University of Alberta Hospital referred for CTS. Inclusion criteria will include adult patients (over age 18) with at least one of the following symptoms:\n\n 1. numbness and parenthesis in the median nerve distribution;\n 2. Precipitation of those symptoms by repetitive motions that are relieved by rubbing and or shaking the hands;\n 3. Nocturnal awakening by those sensory symptoms, or\n 4. Weakness of thumb abduction and thenar atrophy.\n\nExclusion Criteria:\n\n1. Motor unit loss in the median nerve less than 2 SD below the mean for the age as determined by nerve conduction studies.\n2. The presence of other neurologic conditions\n3. Previous carpal tunnel release surgery\n4. Cognitive impairment that renders the patient unable to provide informed consent;\n5. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02141035', 'briefTitle': 'Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome; a Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'Pro00045538'}, 'secondaryIdInfos': [{'id': 'RES0021133', 'type': 'OTHER_GRANT', 'domain': 'University of Alberta Hospital Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetyl-l-carnitine', 'description': 'Acetyl-l-carnitine will be administered for 2 months duration at a dosage of 3000 mg/d starting at the time of decompression surgery.', 'interventionNames': ['Drug: Acetyl-l-carnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be given for 2 months starting at the time of decompression surgery', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Acetyl-l-carnitine', 'type': 'DRUG', 'description': 'Those randomized to the treatment arm will receive the medication at 1 g tid for 60 days', 'armGroupLabels': ['Acetyl-l-carnitine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'The control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5G 0B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Glenrose Hosptial', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T5R2E1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Ming Chan, MB,ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ming Chan', 'investigatorAffiliation': 'University of Alberta'}}}}