Nerve and Muscle Center of Texas

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.

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.

Ongoing Clinical Trials:

2008 - Ongoing	A multi-Center, Single blind study comparing thymectomy to no theymectomy in non-thymomaotus myasthenia gravis patients receiving presnisone.
2009 - Ongoing	Skeletal Muscles Remodelling in COPD
2009 - Ongoing	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).
2009 - Ongoing	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 - Ongoing	A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects with Moderately Severe Diabetic 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.

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