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Thumbnail image 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 treatment pain of diabetic neuropathy and for modification of the disease process.
FDA Letter The Nerve and Muscle Center's research department is staffed by qualified and certified research coordinators and is proud to have passed an FDA inspections without receiving form 483.

 

Dr. Shaibani is the principle investigator on all of the trials listed below with the exception of COPD where he is the (co-investigator).

Ongoing Clinical Trials:

2013-ongoing PRECISIONMED, Protocol 4800, A single or multiple visits protocol for collection of DNA/SERUM/PLASMA/CSF in Amyotrophic Lateral Sclerosis and related disorder.
2015-ongoing Prospective Study Of Cerebral Spinal Fluid (Csf) Collection from Subjects Diagnosed with Amyotrophic Lateral Sclerosis (Als) & Normal Controls for Research.
2012-ongoing Using the next generation sequencing to unravel the pathogenesis of sporadic inclusion body myositis (IBM)- The international IBM consortium genetic study.
2015-ongoing CCT-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-terminated GRC 17536-205: Phase 2b, Dose range finding, 12 week, 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-ongoing CLO-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. 
2015-2016 DS1971-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-ongoing EAP-001: An open-label, expanded access protocol for Firdapse (amifampridine phosphate; 34-diaminopyridine phosphate) treatment in patients with lambert-eaton myastenic syndrome (LEMS), congenital myasthenic syndromes (CMS) and downbeat nystagmus.
2015-2016 CBYM338B2203E1: 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-ongoing IPANEMA: a investigational blood sample collection for subjects  with unclassified myopathy to determine the prevalence of pompe disease.
2016-ongoing

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the safety and efficacy of VM202 in subjects with Painful Diabetic Peripheral Neuropathy

 

Completed Clinical Trials:

2000 – 2001 Principal 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 – 2002

Principal 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 – 2002 Principal 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 – 2003 Principal 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 – 2004 Principal Investigator, A randomized, double-blind placebo controlled trial to investigate 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 – 2006 Principle Investigator, A randomized, double-blind placebo controlled parallel-group study to investigate safety and efficacy of LY333531 in patients with peripheral neuropathy due to diabetes.
2003 – 2004 Principal Investigator, A Phase II randomized double-blind placebo controlled trial of Fidarestat SNK-860 9mg and 30mg in subjects with diabetic polyneuropathy
2003 – 2004 Principal 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 – 2005 A 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 - 2005

A multi-center, 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 – 2008 A multi-center, open-label, follow-on trial to assess the long-term safety and efficacy of SPM927 in subjects with painful distal diabetic neuropathy.
2004 – 2005 A 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 – 2006 An open-label Extension safety trial of Pregabalin (CI-1008) in subjects with diabetic neuropathy.
2004 – 2006 A multi-center, randomized, double blind, placebo-controlled multiple dose study of the efficacy and safety of AS-3201 in patients with diabetic sensorimotor polyneuropathy.
2005 – 2006 A multi-center, 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 – 2007

A 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 – 2007 A randomized, double-blind, placebo-controlled, multi-center, phase 2 study designed to assess the efficacy and safety of FK1706 in subjects with painful diabetic neuropathy.
2006 – 2007 A randomized, double-blind, placebo-controlled, multi-center, phase 2 study designed to assess the efficacy and safety of FK1706 in a Capsaicin-induced denervation model in subjects with diabetic neuropathy.
2006 – 2008 A 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 – 2007 A 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 – 2007 An investigation of the Reliability and Validity of the Modified Toronto Clinical Score in Patients with Diabetic Sensorimotor Polyeneuropathy.
2006 – 2007 A 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 – 2008 Long-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 – 2007 A 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 – 2007

A 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 - 2008 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients with Painful Diabetic Neuropathy.
2007 - 2008 A multi-center, 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 - 2008 A 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 - 2009 Study 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 – 2010 A Phase 2 Repeat Dose Clinical Trial of SB-509 in Subjects with Diabetic Neuropathy.
2006 – 2010 A phase 2 repeat dosing clinical trial of SB-509 in subjects with moderate to severe diabetic neuropathy and unmeasurable nerve conduction velocity.
2006 – 2010 A Phase 2 Study of Stem-Cell-Mobilization in Subjects with Diabetic Neuropathy receiving SB-509
2009 - 2010 A phase 2 Repeat-Dosing clinical trial of SB-509 in Subjects with Amyotrophic Lateral Sclerosis (ALS).
2009 - 2010 A Multi Center, 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 - 2011 A 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 - 2011 A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects with Moderately Severe Diabetic Neuropathy

2008 - 2013

A multi-Center, Single blind study comparing thymectomy to no theymectomy in non-thymomaotus myasthenia gravis patients receiving presnisone.
2009 - 2013 Skeletal Muscles Remodelling in COPD
2009 - 2013 A 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).
2010-2013 A Phase 3B Multi center, Double-Blind, Efficacy and Safety Study of  Pregabalin in the treatment of Patients with Inadequately Treated Painful Diabetic Peripheral Neuropathy
2012-2013 A phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of SKL1119 for the Pain of Diabetic Peripheral Neuropathy.
2011-2013 Phase 2 Trial of Methotrexate in Myasthenia Gravis
2011-2013 A Study Of Pregabalin in the Treatment Of Subjects with Painful Diabetic Peripheral Neuropathy with Background Treatment of Nsaid for other Pain Conditions.
2011-2013 Daiichi 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
2012-2013

A 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.

2013-2014 A 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
2013-2014 A Phase II, Double-Blind, Randomized, Placebo- Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 in Subjects With Painful Diabetic Peripheral Neuropathy
2013-2014 QSC01-ALS-01: A study to explore the safety and tolerability of Acthar in patients with Amyotrophic Lateral Sclerosis.
2013-2014 CLO-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.
2013-2014 E05-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.
2013-2014 Health Research Authority: Using Next Generation Sequencing to Unravel the Pathogenesis of Sporadic Inclusion Body Myositis (IBM).
2014-2014 CLO-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.
2014-2015 A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
2013-2015 CBYM338B2203: 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.
2015-2016 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
2015-2016 B3291026 - 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)
2015-2016 Protocol 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.
2015-2015 05035 Prospective study blood sample collection from subjects diagnosed with myasthenia gravis (MG).
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A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Condition

 
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