Carpal Tunnel SyndromePhase 2/3NCT02141035
Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome
A Phase 2/3 study testing Acetyl-l-carnitine in people with Carpal Tunnel Syndrome and Compression Neuropathy, run by University of Alberta at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, Compression Neuropathy
- What is being tested?
- Acetyl-l-carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2015to Sep 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Glenrose Hosptial
Edmonton, Alberta, T5G 0B7
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
University of Alberta Hospital
Edmonton, Alberta, T5R2E1
About this study
Official title: Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome; a Randomized Control Trial.
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.
Read the detailed description
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.
- Conditions
- Carpal Tunnel Syndrome, Compression Neuropathy
- Being tested
- Acetyl-l-carnitine, placebo
- Keywords
- Acetyl-l-carnitine, Carpal tunnel syndrome, Motor unit number estimation, Compression neuropathy
- Medical subject headings
- Carpal Tunnel Syndrome, Tomaculous neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl-l-carnitineDrug
Those randomized to the treatment arm will receive the medication at 1 g tid for 60 days
placeboDrug
The control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Acetyl-l-carnitine |
| Placebo | Placebo comparator | Placebo will be given for 2 months starting at the time of decompression surgery Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor unit number estimates
An electromyography technique used to quantify the number of motor units in a motor nerve.
Measured: Baseline, 3, 6, and 12 months
Secondary outcomes (7)
Change in two point discrimination
Measurement of spatial determination
Measured: Baseline, 3, 6, and 12 months
Change in pressure sensitivity using Semmes-Weinstein Monofilaments
Measurement of pressure sensitivity
Measured: Baseline, 3, 6, and 12 months
Change in cold detection threshold
Measured: Baseline, 3, 6, and 12 months
Change in pain detection thresholds
Quantitative measurements of pain thresholds
Measured: Baseline, 3, 6, and 12 months
Change in hand dexterity using the Purdue Pegboard
Measurement of hand dexterity
Measured: Baseline, 3, 6, and 12 months
Change in disability scores using the Disability of Arm, Shoulder and Hand questionnaire
Validated questionnaire for functionality in carpal tunnel syndrome
Measured: Baseline, 3, 6, and 12 months
Change in hand symptoms using the Levine questionnaire for carpal tunnel syndrome
Validated questionnaire for functionality in carpal tunnel syndrome
Measured: Baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startSep 2015
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Chan, University of Alberta
- Investigators
- Ming Chan, MB,ChB, Principal investigator, Professor, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141035
- Sponsor's protocol ID
- Pro00045538
- Other IDs
- RES0021133
- Status last verified
- Oct 2017
- First submitted
- 13 May 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12877853Barhwal 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.
PubMed 18500755Bianchi 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.
PubMed 16039110Bitar 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.
PubMed 11932599Boyd 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.
PubMed 12845152Bunge 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.
PubMed 8260833Chen 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.
PubMed 16042313Grandis 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.
PubMed 18370471De 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.
PubMed 12455197Dudek 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.
PubMed 9005851Evans 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.
PubMed 18940920Fu 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.
PubMed 7751953Gordon 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.
PubMed 19800329Gutmann E, Guttmann L, Medawar PB, & Young JZ (1942). The rate of regeneration of nerve. J Exp Biol 19, 14-44.
Hall SM. The biology of chronically denervated Schwann cells. Ann N Y Acad Sci. 1999 Sep 14;883:215-33.
PubMed 10586247
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome; a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT02141035
- Acronym / sponsor ID
- Pro00045538
- Conditions
- Carpal Tunnel Syndrome, Compression Neuropathy
- Keywords
- Acetyl-l-carnitine, Carpal tunnel syndrome, Motor unit number estimation, Compression neuropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetyl-l-carnitine | Experimental | Drug: Acetyl-l-carnitineAcetyl-l-carnitine will be administered for 2 months duration at a dosage of 3000 mg/d starting at the time of decompression surgery. |
| Placebo | Placebo comparator | Drug: placeboPlacebo will be given for 2 months starting at the time of decompression surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl-l-carnitineThose randomized to the treatment arm will receive the medication at 1 g tid for 60 days | Drug | Acetyl-l-carnitine |
| placeboThe control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days | Drug | Placebo |
Primary outcome
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.
7 secondary outcomes
Change in two point discrimination
Time frame: Baseline, 3, 6, and 12 months
Change in pressure sensitivity using Semmes-Weinstein Monofilaments
Time frame: Baseline, 3, 6, and 12 months
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
Change in hand dexterity using the Purdue Pegboard
Time frame: Baseline, 3, 6, and 12 months
Change in disability scores using the Disability of Arm, Shoulder and Hand questionnaire
Time frame: Baseline, 3, 6, and 12 months
Change in hand symptoms using the Levine questionnaire for carpal tunnel syndrome
Time frame: Baseline, 3, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Background: PubMed 12877853Atroshi 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.
- Background: PubMed 18500755Barhwal 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.
- Background: PubMed 16039110Bianchi 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.
- Background: PubMed 11932599Bitar 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.
- Background: PubMed 12845152Boyd 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.
- Background: PubMed 8260833Bunge 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.
- Background: PubMed 16042313Chen 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.
- Background: PubMed 18370471Grandis 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.
- Background: PubMed 12455197De 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.
- Background: PubMed 9005851Dudek 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.
- Background: PubMed 18940920Evans 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.
- Background: PubMed 7751953Fu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Chan, MB,ChB principal investigator
Professor, University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acetyl-l-carnitine in people with Carpal Tunnel Syndrome and Compression Neuropathy, run by University of Alberta at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor unit number estimates (time frame: Baseline, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02141035, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.