The Nerve and Muscle Center’s research department was established in 1998 and is heavily involved in clinical trials funded by pharmaceutical companies and the FDA on the following subjects:

Diabetic Neuropathy:

  • The center has participated in more than 40 trial of this kind including the ones that resulted in FDA approval of the only two approved medications for painful diabetic neuropathy (Pregabalin and Delouxitine).
  • The center has become nationally and internationally renowned in conducting these trials, many of which resulted in publications in peer-reviewed journals.
  • Our trials involve agents for treating pain of diabetic neuropathy and for modification of the disease process.
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The Nerve and Muscle Center’s research department is staffed by qualified and certified research coordinators and is proud to have passed FDA inspections without receiving form 483.

Dr. Shaibani is the principal investigator on all of the trials listed below

Ongoing Clinical Trials:

2013-ongoingPRECISIONMED, Protocol 4800, A single or multiple visits protocol for collection of DNA/SERUM/PLASMA/CSF in Amyotrophic Lateral Sclerosis and related disorder.
2015-ongoingProspective Study Of Cerebral Spinal Fluid (Csf) Collection from Subjects Diagnosed with Amyotrophic Lateral Sclerosis (Als) & Normal Controls for Research.
2018-ongoingPhase 2/3 Study of Arimoclomol in Inclusion Body Myositis (IBM).A Randomized, Double-blind, Placebo-Controlled Trial.
2017-ongoingA Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM).
2018-ongoingRandomised, double-blind, placebo-controlled, parallel group,multicentre study assessing the Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS.
2019-ongoingOpen, non-randomised, uncontrolled, multicentre phase III extension study to the REFALS study to evaluate long-term safety of oral levosimendan in ALS patients.
2019-ongoingRandomized, Multi-centered Double Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Memantine at 20 mg BID in Patients With ALS.

Completed Clinical Trials:

2018 – 2020Assessment of myasthenia gravis patient’s expectations in routine medical practice ( EMPATHY).
Protocol number: SAIRAB-18-0009
2000 – 2001Principal Investigator, A randomized, double-blind, placebo-controlled comparison of the safety and efficacy of ABT-594 to placebo in subjects with painful diabetic neuropathy.
2001 – 2002Principal Investigator, A Phase II randomized, double-blind, placebo-controlled, dose-finding study of SNK-860 in subjects with diabetic neuropathy. A nine-month placebo-controlled Phase II extension of 3-mg SNK-860 in subjects with diabetic neuropathy
2001 – 2002Principal Investigator, multicenter, double-blind, randomized, placebo-control, parallel-group study to evaluate the safety and efficacy of Trileptal in patients with neuropathic pain due to diabetic neuropathy
2002 – 2003Principal Investigator, multicenter, double-blind, randomized, placebo-control, parallel-group study to evaluate the safety and efficacy of three dose groups of Trileptal in patients with neuropathic pain due to diabetic neuropathy
2002 – 2004Principal Investigator, A randomized, double-blind placebo-controlled trial to investigate the safety and efficacy of SPM 927 in patients with painful diabetic neuropathy. An open-label follow-on trial to assess the long-term safety and efficacy of oral SPM 927 in subjects with diabetic neuropathy
2002 – 2006Principle Investigator, A randomized, double-blind placebo-controlled parallel-group study to investigate the safety and efficacy of LY333531 in patients with peripheral neuropathy due to diabetes.
2003 – 2004Principal Investigator, A Phase II randomized double-blind placebo-controlled trial of Fidarestat SNK-860 9mg and 30mg in subjects with diabetic polyneuropathy
2003 – 2004Principal Investigator, A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of lamotrigine in subjects with neuropathic pain and inadequate pain relief with gabapentin, tricyclic antidepressants or non-narcotic analgesics.
2004 – 2005A randomized, double-blind placebo-controlled flexible-dose study of the efficacy and safety of memantine in comparison to gabapentin in patients with painful diabetic neuropathy.
2004 – 2005A multi-centre, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of 200,400, and 600mg/day of SPM927 in subjects with painful distal diabetic neuropathy
2004 – 2008A multi-centre, open-label, follow-on trial to assess the long-term safety and efficacy of SPM927 in subjects with painful distal diabetic neuropathy.
2004 – 2005A 13-Week, double-blind, placebo-controlled phase 4 trial of Pregabalin (CI-1008, 600 mg/day) for relief in subjects with painful diabetic peripheral neuropathy.
2004 – 2006An open-label Extension safety trial of Pregabalin (CI-1008) in subjects with diabetic neuropathy.
2004 – 2006A multi-centre, randomized, double-blind, placebo-controlled multiple-dose study of the efficacy and safety of AS-3201 in patients with diabetic sensorimotor polyneuropathy.
2005 – 2006A multi-centre, randomized, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of SPM 927 (200, 400, and 600 mg/day) in subjects with Painful Distal Diabetic Neuropathy.
2005 – 2007A double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Dextromethorphan and Quinidine at two dose levels in the treatment of the pain of diabetic neuropathy.
2005 – 2007A randomized, double-blind, placebo-controlled, multi-centre, phase 2 study designed to assess the efficacy and safety of FK1706 in subjects with painful diabetic neuropathy.
2006 – 2007A randomized, double-blind, placebo-controlled, multi-centre, phase 2 study designed to assess the efficacy and safety of FK1706 in a Capsaicin-induced denervation model in subjects with diabetic neuropathy.
2006 – 2008A phase II, randomized, double-blind, placebo-controlled, 24-week dose-finding study to evaluate the efficacy and safety of 20mg, 40mg and 80mg of MCC-257 in with diabetic polyneuropathy.
2006 – 2007A multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of Gabapentin Extended Release (G-ER) tablets in the treatment of patients with diabetic peripheral neuropathy.
2006 – 2007An investigation of the Reliability and Validity of the Modified Toronto Clinical Score in Patients with Diabetic Sensorimotor Polyneuropathy.
2006 – 2007A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Study to Evaluate the Efficacy and Safety of 3 Doses of TAK-583 in Subjects with Mild to Moderate Diabetic Peripheral Neuropathy.
2006 – 2008Long-term Safety and Efficacy Study of Open-label Treatment with 80 mg MCC-257, in Patients with Mild to Moderate Diabetic Polyneuropathy: A-24-Week Open-label Extension after Completion of Study MCC-257/A03.
2006 – 2007A Multi-Center, Double-Blind, Randomized, Placebo-controlled, Multiple Dose, Parallel Design, Dose-Ranging Study of the Safety and Efficacy of AGN 203818 in Patients with Painful Diabetic Peripheral Neuropathy.
2006 – 2007A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy.
2007 – 2008A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients with Painful Diabetic Neuropathy.
2007 – 2008A multi-centre, randomized, double-blind, placebo-controlled study of the effect of SSR180575 at two doses for 24 weeks treatment on the rate of regeneration of epidermal nerve fibers in patients with mild diabetic peripheral neuropathy
2008 – 2008A Phase 2a Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of ADL5859 100mg BID in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy.
2008 – 2009Study PXN110448: A dose-response study of XP13512, compared with concurrent placebo control and Lyrica (pregabalin), in subjects with neuropathic pain associated with diabetic peripheral neuropathy (DPN)
2006 – 2010A Phase 2 Repeat Dose Clinical Trial of SB-509 in Subjects with Diabetic Neuropathy.
2006 – 2010A phase 2 repeat dosing clinical trial of SB-509 in subjects with moderate to severe diabetic neuropathy and unmeasurable nerve conduction velocity.
2006 – 2010A Phase 2 Study of Stem-Cell-Mobilization in Subjects with Diabetic Neuropathy receiving SB-509
2009 – 2010A phase 2 Repeat-Dosing clinical trial of SB-509 in Subjects with Amyotrophic Lateral Sclerosis (ALS).
2009 – 2010A Multi-centre, Randomized, Double-blind, Parallel-Group Study Comparing the Efficacy and Safety of Clonidine Topical Gel, 0.1% with Placebo in the Management of Pain Associated with Painful Diabetic Neuropathy, (ARCION THERAPEUTICS), Protocol CLO-027.
2009 – 2011A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Diabetic Painful Neuropathy and Small Fiber Neuropathy Associated With Impaired Glucose Tolerance, Followed by a Double-Blind Safety Extension and an Open-Label Safety Extension.
2009 – 2011A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects with Moderately Severe Diabetic Neuropathy
2008 – 2013A multi-Center, Single-blind study comparing thymectomy to no thymectomy in non-thymomaotus myasthenia gravis patients receiving prednisone.
2009 – 2013Skeletal Muscles Remodelling in COPD
2009 – 2013A 2-year, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor polyneuropathy, (Eisai).
2010-2013A Phase 3B Multicenter, Double-Blind, Efficacy and Safety Study of  Pregabalin in the Treatment of Patients with Inadequately Treated Painful Diabetic Peripheral Neuropathy
2012-2013A phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of SKL1119 for the Pain of Diabetic Peripheral Neuropathy.
2011-2013Phase 2 Trial of Methotrexate in Myasthenia Gravis
2011-2013A Study Of Pregabalin in the Treatment Of Subjects with Painful Diabetic Peripheral Neuropathy with Background Treatment of Nsaid for other Pain Conditions.
2011-2013Daiichi Sankyo, DS5565-A-U201: A Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Adaptive Study of DS-5565 for Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (DPN). PAREXEL Number 203065
2012-2013A Phase 3b Multicenter, Double-Blind, Randomized, Placebo-Controlled Cross-Over Efficacy and Safety of Pregabalin in the Treatment of Patients with Painful Diabetic Peripheral Neuropathy and Pain on Walking.
2013-2014A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CBX129801 (Ersatta), Long-Acting Synthetic C-Peptide, in Type 1 Diabetes Mellitus Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
2013-2014A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 in Subjects With Painful Diabetic Peripheral Neuropathy
2013-2014QSC01-ALS-01: A study to explore the safety and tolerability of Acthar in patients with Amyotrophic Lateral Sclerosis.
2013-2014CLO-290, CLONIDINE HYDROCHLORIDE TOPICAL GEL, 0.1%, A multicenter randomized, Double-Blind, Placebo-Controlled, 2-Arm Parallel-Group, Study to determine the efficacy and safety of Clonidine Hydrochloride Topical Gel,0.1% in the treatment of pain in association with Painful Diabetic Neuropathy.
2013-2014E05-CL-3004, A phase III, Double-blind, Randomized, placebo-controlled, multicenter study evaluating the efficacy and safety of QUTENZA® in subjects with Painful Diabetic Peripheral Neuropathy.
2013-2014Health Research Authority: Using Next-Generation Sequencing to Unravel the Pathogenesis of Sporadic Inclusion Body Myositis (IBM).
2014-2014CLO-311 A multicenter, open-label, single-arm study to evaluate the long term safety and tolerability of Clonidine Hydrochloride Topical Gel 0.1% in the treatment of pain associated with Painful Diabetic Neuropathy.
2014-2015A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
2013-2015CBYM338B2203: A Randomized finding, Pivotal, Phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with Sporadic Inclusion Body Myositis.
2015-2016A Phase 2a Randomized, Double-Blind, Multicenter, Placebo and Active Controlled Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects with Painful Diabetic Peripheral Neuropathy
2015-2016B3291026 – A randomized double-blind placebo and active-controlled parallel-group Phase 2 study to evaluate PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)
2015-2016Protocol 3662-CL-0049: A Phase 2a Randomized, Double-Blind, Multicenter, Placebo and Active Controlled Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects with Painful Diabetic Peripheral Neuropathy.
2015-201505035 Prospective study blood sample collection from subjects diagnosed with myasthenia gravis (MG).
2012-2018Using the next-generation sequencing to unravel the pathogenesis of sporadic inclusion body myositis (IBM)- The international IBM consortium genetic study.
2015-2017CCT-PDA-002-DPN-002: Phase 2, randomized, double-blind placebo-controlled, dose range-finding study to assess the efficacy and safety of intramuscular injection of human placenta-derived cells (PDA-002) in subjects with diabetic peripheral neuropathy.
2015-terminatedGRC 17536-205: Phase 2b, Dose range finding, 12 weeks, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of different doses of GRC 17536 in patients with painful diabetic peripheral neuropathy.
2015-2017CLO-291: A multicenter randomized, double-blind, parallel-group study comparing the efficacy and safety of clonidine hydrochloride topical gel, 0.1% to, clonidine HCl gell comparator in the management of painful diabetic neuropathy.
2015-2016DS1971-A-U202: A randomized double-blind placebo and active-controlled parallel-group study to evaluate the efficacy and safety of DS-1971A for the treatment of diabetic peripheral neuropathic pain (DPNP).
2015-2018EAP-001: An open-label, expanded access protocol for Firdapse (amifampridine phosphate; 34-diaminopyridine phosphate) treatment in patients with Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS) and downbeat nystagmus.
2015-2016CBYM338B2203E1: Novartis pharmaceuticals trial entitled: Extension of the CBYM338B2203 phase 2b/3 study to evaluate the long-term safety and tolerability of intravenous BYM338 in patients with sporadic body myositis.
2015-2018IPANEMA: an investigational blood sample collection for subjects with unclassified myopathy to determine the prevalence of Pompe disease.
2016-2019A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the safety and efficacy of VM202 in subjects with Painful Diabetic Peripheral Neuropathy.