A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma
NCT ID: NCT04026568
Last Updated: 2022-10-18
Study Results
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
1 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-08-17
Study Completion Date
2022-07-18
Brief Summary
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The purpose of this study is to evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. The investigational treatment will be used to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.
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Detailed Description
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This proposal contains two distinct aims to be investigated in two similar but distinct groups of patients.
Aim 1: To examine the mechanistic effect of 4AP on the return of sensorimotor function and EDX sensitivity in the setting of nerve dysfunction from orthopaedic trauma. This aim tests the hypothesis that oral one-time administration of 4AP provides transient return of function and EDX sensitivity to the traumatically denervated limb in alert patients with known limb injuries not involving the central nervous system.
Aim 2: To examine the mechanistic effect of 4AP on the return of sensorimotor function and EDX sensitivity in the setting of iatrogenic nerve injury after surgical intervention. This aim tests the identical hypothesis as in Aim 1 in a distinct group of patients, whose nerve dysfunction is the result of a clinical intervention, and whose function before that intervention was intact.
Scientific Background and Gaps
Neurological injury in the form of traction or crush to nerves that control muscles and sensory function is common. Because an understanding of these injuries is only now beginning to emerge, research on potential treatments is an important next step. Through experiments performed on animals with the Acorda Therapeutics, Inc. version of the drug (AMPYRA®), 4-aminopyridine (4-AP) has been strikingly effective in ameliorating the effect of a standardized peripheral nerve crush injury. The peripheral nerve injury used in the experiments was a standard model of peripheral nerve injury used to measure recovery in animals and is a model of peripheral nerve traction and crush injury that has been studied for over thirty years. The investigators have found that:
1. 4-AP administration in a single dose given on day three after the injury led to a drastic reduction in the dysfunction afforded by a crush injury just days after the crush itself.
2. 4-AP treatment's effect was short-lived after a single dose and was, in effect, diagnostic of the potential to recover in a nerve that was crushed but not shattered.
3. Severed nerves show no capacity to recover even with 4-AP treatment.
4. The treatment in a daily regimen led to profound, lasting, permanent improvement in the speed of recovery in these animals.
4-AP is used in some of the most fragile of neurologically-ailing patients and is currently a mainline treatment in the setting of multiple sclerosis (1). Multiple sclerosis patients suffer a demyelinating disorder that causes the stripping of the myelin sheath from around neurons in the peripheral and central nervous system. The myelin covering allows for normal conduction of impulses and, without such covering, impulses are small, impaired, impeded, and ineffective. The recognition that crush injuries to nerves do not simply sever the axonal fibers but also demyelinate some population of nerve cells has led to the idea to study the treatment of peripheral nerve traumatic injuries in humans using 4-AP.
Previous Data
4-AP has been studied in humans since the early 1980s, and principles of safe usage are extremely well established. For the purposes of this proposal, the immediate release formulation of 4-AP, sometimes called fampridine will be referred to as IR 4-AP. The proposed version of the drug used in this study is an extended release formulation of 4-AP, called dalfampridine, which was marketed under the trade name AMPYRA, by Acorda Therapeutics. Recently, this extended release formulation has become available as a generic, which will be referred to as generic AMPYRA or dalfampridine. Essentially identical principles apply whether 4-AP is provided in an orally available immediate release formulation (IR 4-AP) or an orally available sustained release formulation (dalfampridine). The safety of 4-AP appears to be determined solely by serum levels.
It has long been recognized that the most significant safety concern regarding 4-AP is an increased frequency in seizures, which occurs in a small percentage of patients if serum levels exceed 100 ng/ml. Therefore, dosages are chosen to maintain serum levels that do not exceed 50-60ng/ml. In this proposal, 5mg of study drug will be administered once every six hours, for a total dosage per day of 20 mg. This total dose, as indicated by multiple previous studies on immediate release 4-AP, has an excellent safety profile even in the fragile population of patients with multiple sclerosis. A sustained release formulation of 4-AP (AMPYRA®) at this same dose is FDA approved for use in the multiple sclerosis population even with a known risk of seizure activity in these patients.
It is important to note that multiple studies on 4-AP also include patients with chronic stroke, chronic spinal cord injury, transverse myelitis, primary lateral sclerosis, Lambert-Eaton myasthenic syndrome, ocular nystagmus, nonarteritic anterior ischemic optic neuropathy, spinal muscular atrophy, chronic Guillain-Barre syndrome, episodic ataxia Type 2, obstructive sleep apnea and spinocerebellar ataxias. Over 45 clinical trials have been conducted in the US alone (as listed on the Clinicaltrials.gov website). There are also 49 primary publications on clinical trials outcomes on 4-AP, which include patients with multiple sclerosis, chronic spinal cord injury, spinocerebellar ataxias and chronic stroke.
The many trials on 4-AP have been conducted using both immediate release 4-AP and sustained release 4-AP. The difference between the immediate release and sustained release formulations are that the sustained release formulation helps to decrease the peaks and troughs in serum levels that can occur with larger doses of immediate release formulations.
The Study Rationale is to evaluate the role of 4-aminopyridine (4AP) on the diagnosis of complete (severed) vs incomplete (non-severed) peripheral nerve injury (PNI). The investigational treatment will be used to test the hypothesis that 4AP allows the identification of incomplete injuries earlier than standard electrodiagnostic (EDX) and clinical assessment.
Aim 1: To examine the mechanistic effect of 4AP on the return of sensorimotor function and EDX sensitivity in the setting of nerve dysfunction from orthopaedic trauma. This aim tests the hypothesis that oral one-time administration of 4AP provides transient return of function and EDX sensitivity to the traumatically denervated limb in alert patients with known limb injuries not involving the central nervous system.
Aim 2: To examine the mechanistic effect of 4AP on the return of sensorimotor function and EDX sensitivity in the setting of iatrogenic nerve injury after surgical intervention. This aim tests the identical hypothesis as in Aim 1 in a distinct group of patients, whose nerve dysfunction is the result of a clinical intervention, and whose function before that intervention was intact.
Scientific Background and Gaps
Neurological injury in the form of traction or crush to nerves that control muscles and sensory function is common. Because an understanding of these injuries is only now beginning to emerge, research on potential treatments is an important next step. Through experiments performed on animals with the Acorda Therapeutics, Inc. version of the drug (AMPYRA®), 4-aminopyridine (4-AP) has been strikingly effective in ameliorating the effect of a standardized peripheral nerve crush injury. The peripheral nerve injury used in the experiments was a standard model of peripheral nerve injury used to measure recovery in animals and is a model of peripheral nerve traction and crush injury that has been studied for over thirty years. The investigators have found that:
1. 4-AP administration in a single dose given on day three after the injury led to a drastic reduction in the dysfunction afforded by a crush injury just days after the crush itself.
2. 4-AP treatment's effect was short-lived after a single dose and was, in effect, diagnostic of the potential to recover in a nerve that was crushed but not shattered.
3. Severed nerves show no capacity to recover even with 4-AP treatment.
4. The treatment in a daily regimen led to profound, lasting, permanent improvement in the speed of recovery in these animals.
4-AP is used in some of the most fragile of neurologically-ailing patients and is currently a mainline treatment in the setting of multiple sclerosis (1). Multiple sclerosis patients suffer a demyelinating disorder that causes the stripping of the myelin sheath from around neurons in the peripheral and central nervous system. The myelin covering allows for normal conduction of impulses and, without such covering, impulses are small, impaired, impeded, and ineffective. The recognition that crush injuries to nerves do not simply sever the axonal fibers but also demyelinate some population of nerve cells has led to the idea to study the treatment of peripheral nerve traumatic injuries in humans using 4-AP.
Previous Data
4-AP has been studied in humans since the early 1980s, and principles of safe usage are extremely well established. For the purposes of this proposal, the immediate release formulation of 4-AP, sometimes called fampridine will be referred to as IR 4-AP. The proposed version of the drug used in this study is an extended release formulation of 4-AP, called dalfampridine, which was marketed under the trade name AMPYRA, by Acorda Therapeutics. Recently, this extended release formulation has become available as a generic, which will be referred to as generic AMPYRA or dalfampridine. Essentially identical principles apply whether 4-AP is provided in an orally available immediate release formulation (IR 4-AP) or an orally available sustained release formulation (dalfampridine). The safety of 4-AP appears to be determined solely by serum levels.
It has long been recognized that the most significant safety concern regarding 4-AP is an increased frequency in seizures, which occurs in a small percentage of patients if serum levels exceed 100 ng/ml. Therefore, dosages are chosen to maintain serum levels that do not exceed 50-60ng/ml. In this proposal, 5mg of study drug will be administered once every six hours, for a total dosage per day of 20 mg. This total dose, as indicated by multiple previous studies on immediate release 4-AP, has an excellent safety profile even in the fragile population of patients with multiple sclerosis. A sustained release formulation of 4-AP (AMPYRA®) at this same dose is FDA approved for use in the multiple sclerosis population even with a known risk of seizure activity in these patients.
It is important to note that multiple studies on 4-AP also include patients with chronic stroke, chronic spinal cord injury, transverse myelitis, primary lateral sclerosis, Lambert-Eaton myasthenic syndrome, ocular nystagmus, nonarteritic anterior ischemic optic neuropathy, spinal muscular atrophy, chronic Guillain-Barre syndrome, episodic ataxia Type 2, obstructive sleep apnea and spinocerebellar ataxias. Over 45 clinical trials have been conducted in the US alone (as listed on the Clinicaltrials.gov website). There are also 49 primary publications on clinical trials outcomes on 4-AP, which include patients with multiple sclerosis, chronic spinal cord injury, spinocerebellar ataxias and chronic stroke.
The many trials on 4-AP have been conducted using both immediate release 4-AP and sustained release 4-AP. The difference between the immediate release and sustained release formulations are that the sustained release formulation helps to decrease the peaks and troughs in serum levels that can occur with larger doses of immediate release formulations.
The Study Rationale is to evaluate the role of 4-aminopyridine (4AP) on the diagnosis of complete (severed) vs incomplete (non-severed) peripheral nerve injury (PNI). The investigational treatment will be used to test the hypothesis that 4AP allows the identification of incomplete injuries earlier than standard electrodiagnostic (EDX) and clinical assessment.
Conditions
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Nerve Injury
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Single dose 4AP
15mm opaque capsule containing 10mg of 4-AP
Group Type
EXPERIMENTAL
4-Aminopyridine
Intervention Type
DRUG
Single drug test for nerve continuity
Placebo
Opaque capsule identical looking to the 4AP placebo pill
Group Type
PLACEBO_COMPARATOR
Placebo oral tablet
Intervention Type
DRUG
Placebo arm
Interventions
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4-Aminopyridine
Single drug test for nerve continuity
Intervention Type
DRUG
Placebo oral tablet
Placebo arm
Intervention Type
DRUG
Other Intervention Names
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oral dalfampridine
Generic placebo
Eligibility Criteria
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Inclusion Criteria
* Patients with trauma involving two or less limbs where the continuity of a given peripheral nerve or nerves is unclear on presenting physical examination.
* Closed soft tissue envelope obscuring direct observation of the continuity of the affected nerve.
* Cognitive ability to report sensory and motor deficit during examination.
* Able to complete dosing within four days (96 hours) of nerve injury diagnosis.
* Able to provide informed consent
* Eligible for standard of care plan of monitoring vs surgical exploration of the nerve.
* Adults subject aged 18-90
* Known limb trauma which resulted in nerve injury (aim 1) or post-operative/post intervention nerve injury (aim 2).
* Ability to give written informed consent.
* Capable of safely undergoing electrodiagnostic testing (EDX).
* Availability for all testing days and main trial day.
* Closed soft tissue envelope obscuring direct observation of the continuity of the affected nerve.
* Cognitive ability to report sensory and motor deficit during examination.
* Able to complete dosing within four days (96 hours) of nerve injury diagnosis.
* Able to provide informed consent
* Eligible for standard of care plan of monitoring vs surgical exploration of the nerve.
* Adults subject aged 18-90
* Known limb trauma which resulted in nerve injury (aim 1) or post-operative/post intervention nerve injury (aim 2).
* Ability to give written informed consent.
* Capable of safely undergoing electrodiagnostic testing (EDX).
* Availability for all testing days and main trial day.
Exclusion Criteria
* Not able to complete dosing within four days (96 hours) of nerve injury diagnosis
* Distracting injury which prevents adequate examination.
* Plan for surgical exploration of the nerve during the ensuing 48 hours.
* Plan for surgical exploration of the nerve as part of another surgical procedure within 48 hours of evaluation.
* Intoxication during examination or evidence of cognitive deficit that emerges during examination.
* History of multiple sclerosis, stroke or any other diagnosed neurological disorder
* History of hypersensitivity to AMPYRA® or 4-aminopyridine
* Renal impairment based on calculated GFR (GFR\<80 mL/min) This laboratory value is measured in all inpatient trauma patients as part of the standard of care.
* History of difficult compliance with timely follow up or plan to seek care at another institution closer to home.
* Patients outside the age range or unable to consent.
* Patients with a known history of a seizure disorder (4AP overdose can, in selected cases, result in limited seizure activity).
* Patients with a concomitant traumatic brain injury.
* Patients unable to communicate return or loss of sensation.
* Patients unable to exhibit motor control on the affected limb at baseline.
* Patients unwilling to complete the study requirements.
* Patients with injuries too extensive to isolate a single nerve(s) for testing.
* Pregnancy, breastfeeding or incarcerated individuals.
* Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, eg. Cimetidine.
* Distracting injury which prevents adequate examination.
* Plan for surgical exploration of the nerve during the ensuing 48 hours.
* Plan for surgical exploration of the nerve as part of another surgical procedure within 48 hours of evaluation.
* Intoxication during examination or evidence of cognitive deficit that emerges during examination.
* History of multiple sclerosis, stroke or any other diagnosed neurological disorder
* History of hypersensitivity to AMPYRA® or 4-aminopyridine
* Renal impairment based on calculated GFR (GFR\<80 mL/min) This laboratory value is measured in all inpatient trauma patients as part of the standard of care.
* History of difficult compliance with timely follow up or plan to seek care at another institution closer to home.
* Patients outside the age range or unable to consent.
* Patients with a known history of a seizure disorder (4AP overdose can, in selected cases, result in limited seizure activity).
* Patients with a concomitant traumatic brain injury.
* Patients unable to communicate return or loss of sensation.
* Patients unable to exhibit motor control on the affected limb at baseline.
* Patients unwilling to complete the study requirements.
* Patients with injuries too extensive to isolate a single nerve(s) for testing.
* Pregnancy, breastfeeding or incarcerated individuals.
* Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, eg. Cimetidine.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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John C Elfar, MD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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MS Hershey Medical Center
Hershey, Pennsylvania, United States
Site Status
Countries
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United States
References
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Robinson LR. Role of neurophysiologic evaluation in diagnosis. J Am Acad Orthop Surg. 2000 May-Jun;8(3):190-9. doi: 10.5435/00124635-200005000-00006.
Reference Type
BACKGROUND
Robinson LR. Traumatic injury to peripheral nerves. Muscle Nerve. 2000 Jun;23(6):863-73. doi: 10.1002/(sici)1097-4598(200006)23:63.0.co;2-0.
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BACKGROUND
Wilbourn AJ. The electrodiagnostic examination with peripheral nerve injuries. Clin Plast Surg. 2003 Apr;30(2):139-54. doi: 10.1016/s0094-1298(02)00099-8.
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BACKGROUND
Seddon HJ, Medawar PB, Smith H. Rate of regeneration of peripheral nerves in man. J Physiol. 1943 Sep 30;102(2):191-215. doi: 10.1113/jphysiol.1943.sp004027. No abstract available.
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BACKGROUND
SEDDON HJ. Nerve grafting. Ann R Coll Surg Engl. 1963 May;32(5):269-80. No abstract available.
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SUNDERLAND S, BRADLEY KC. Denervation atrophy of the distal stump of a severed nerve. J Comp Neurol. 1950 Dec;93(3):401-9. doi: 10.1002/cne.900930304. No abstract available.
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BACKGROUND
SUNDERLAND S. A classification of peripheral nerve injuries producing loss of function. Brain. 1951 Dec;74(4):491-516. doi: 10.1093/brain/74.4.491. No abstract available.
Reference Type
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Korompilias AV, Lykissas MG, Kostas-Agnantis IP, Vekris MD, Soucacos PN, Beris AE. Approach to radial nerve palsy caused by humerus shaft fracture: is primary exploration necessary? Injury. 2013 Mar;44(3):323-6. doi: 10.1016/j.injury.2013.01.004. Epub 2013 Jan 23.
Reference Type
BACKGROUND
Niver GE, Ilyas AM. Management of radial nerve palsy following fractures of the humerus. Orthop Clin North Am. 2013 Jul;44(3):419-24, x. doi: 10.1016/j.ocl.2013.03.012. Epub 2013 Apr 24.
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BACKGROUND
Li Y, Ning G, Wu Q, Wu Q, Li Y, Feng S. Review of literature of radial nerve injuries associated with humeral fractures-an integrated management strategy. PLoS One. 2013 Nov 8;8(11):e78576. doi: 10.1371/journal.pone.0078576. eCollection 2013.
Reference Type
BACKGROUND
Rocchi M, Tarallo L, Mugnai R, Adani R. Humerus shaft fracture complicated by radial nerve palsy: Is surgical exploration necessary? Musculoskelet Surg. 2016 Dec;100(Suppl 1):53-60. doi: 10.1007/s12306-016-0414-3. Epub 2016 Nov 30.
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BACKGROUND
Han SH, Hong IT, Lee HJ, Lee SJ, Kim U, Kim DW. Primary exploration for radial nerve palsy associated with unstable closed humeral shaft fracture. Ulus Travma Acil Cerrahi Derg. 2017 Sep;23(5):405-409. doi: 10.5505/tjtes.2017.26517.
Reference Type
BACKGROUND
Chang G, Ilyas AM. Radial Nerve Palsy After Humeral Shaft Fractures: The Case for Early Exploration and a New Classification to Guide Treatment and Prognosis. Hand Clin. 2018 Feb;34(1):105-112. doi: 10.1016/j.hcl.2017.09.011.
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BACKGROUND
Perry JD. Electrodiagnosis in musculo-skeletal disease. Best Pract Res Clin Rheumatol. 2005 Jun;19(3):453-66. doi: 10.1016/j.berh.2005.01.007.
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Korte N, Schenk HC, Grothe C, Tipold A, Haastert-Talini K. Evaluation of periodic electrodiagnostic measurements to monitor motor recovery after different peripheral nerve lesions in the rat. Muscle Nerve. 2011 Jul;44(1):63-73. doi: 10.1002/mus.22023.
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BACKGROUND
Capacio BR, Byers CE, Matthews RL, Chang FC. A method for determining 4-aminopyridine in plasma: pharmacokinetics in anaesthetized guinea pigs after intravenous administration. Biomed Chromatogr. 1996 May-Jun;10(3):111-6. doi: 10.1002/(SICI)1099-0801(199605)10:33.0.CO;2-E.
Reference Type
BACKGROUND
Elfar JC, Yaseen Z, Stern PJ, Kiefhaber TR. Individual finger sensibility in carpal tunnel syndrome. J Hand Surg Am. 2010 Nov;35(11):1807-12. doi: 10.1016/j.jhsa.2010.08.013.
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BACKGROUND
Sahin F, Atalay NS, Akkaya N, Ercidogan O, Basakci B, Kuran B. The correlation of neurophysiological findings with clinical and functional status in patients following traumatic nerve injury. J Hand Surg Eur Vol. 2014 Feb;39(2):199-206. doi: 10.1177/1753193413479507. Epub 2013 Mar 1.
Reference Type
BACKGROUND
Sims SE, Engel L, Hammert WC, Elfar JC. Hand Sensibility, Strength, and Laxity of High-Level Musicians Compared to Nonmusicians. J Hand Surg Am. 2015 Oct;40(10):1996-2002.e5. doi: 10.1016/j.jhsa.2015.06.009. Epub 2015 Aug 5.
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BACKGROUND
Chimenti PC, McIntyre AW, Childs SM, Hammert WC, Elfar JC. Prospective cohort study of symptom resolution outside of the ulnar nerve distribution following cubital tunnel release. Hand (N Y). 2015 Jun;10(2):177-83. doi: 10.1007/s11552-014-9688-9.
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BACKGROUND
Chimenti PC, McIntyre AW, Childs SM, Hammert WC, Elfar JC. Combined Cubital and Carpal Tunnel Release Results in Symptom Resolution Outside of the Median or Ulnar Nerve Distributions. Open Orthop J. 2016 May 24;10:111-9. doi: 10.2174/1874325001610010111. eCollection 2016.
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Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
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Roberts C. Modelling patterns of agreement for nominal scales. Stat Med. 2008 Mar 15;27(6):810-30. doi: 10.1002/sim.2945.
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Kim J, Farahmand M, Dunn C, Davies Z, Frisbee E, Milla C, Wine JJ. Evaporimeter and Bubble-Imaging Measures of Sweat Gland Secretion Rates. PLoS One. 2016 Oct 21;11(10):e0165254. doi: 10.1371/journal.pone.0165254. eCollection 2016.
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BACKGROUND
Kiistala R, Kiistala U, Parkkinen MU, Mustakallio KK. Local sweat stimulation with the skin prick technique. Acta Derm Venereol. 1984;64(5):384-8.
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Park SJ, Tamura T. Distribution of evaporation rate on human body surface. Ann Physiol Anthropol. 1992 Nov;11(6):593-609. doi: 10.2114/ahs1983.11.593.
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Buchmann SJ, Penzlin AI, Kubasch ML, Illigens BM, Siepmann T. Assessment of sudomotor function. Clin Auton Res. 2019 Feb;29(1):41-53. doi: 10.1007/s10286-018-0530-2. Epub 2018 May 8.
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BACKGROUND
Cardenas DD, Ditunno J, Graziani V, Jackson AB, Lammertse D, Potter P, Sipski M, Cohen R, Blight AR. Phase 2 trial of sustained-release fampridine in chronic spinal cord injury. Spinal Cord. 2007 Feb;45(2):158-68. doi: 10.1038/sj.sc.3101947. Epub 2006 Jun 13.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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https://www.ncbi.nlm.nih.gov/pubmed/26253604
Hand sensibility, strength, and laxity of high-level musicians compared to nonmusicians
Other Identifiers
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STUDY00012040
Identifier Type: -
Identifier Source: org_study_id
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