BARRY JAY CUTLER, M.D.

bcutler@smgumc.com

Board certified neurologist with a special interest in seizure and panic disorders, headaches, stroke, Parkinson’s disease, Multiple Sclerosis, Alzheimer’s and the dementias.  Medical Director of Neurology Clinical Research, Inc.

PROFESSIONAL AND TEACHING ACTIVITIES

[1977–present] Practice of Neurology

[1985-present] Vice President, Neurology Clinical Research, Inc. (Formerly Neurological Associates)

MEDICAL DEGREE

[1973] Hahnemann Medical College and Hospital, Philadelphia, PA

CERTIFICATIONS, QUALIFICATIONS AND APPOINTMENTS

[1968] Albright College, Reading, PA, Bachelor of Science

[1985] The American Board of Psychiatry and Neurology

Good Clinical Practices (Sponsored by Eli Lilly and Company)

GRADUATE TRAINING

Residency: Transitional year

[1974-1977] (Hahnemann Medical College and Hospital, Philadelphia, PA)

Internship:

   [1973-1974] (Monmouth Medical Center, Long Branch, NJ)

AFFILIATED ASSOCIATIONS

·         American Academy of Neurology American Academy of Pharmaceutical Physicians

·         The Florida Society of Neurology, Inc.

RESEARCH, PRESENTATIONS, PUBLISHED BOOKS AND PAPERS

SEIZURE DISORDERS

[1985-1986] Double-blind, multiclinic crossover study of an anti-convulsive compound and placebo, as add-on anticonvulsant therapy.

[1991] Study of IM Fosphenytoin substituted for oral phenytoin.

[1994-1995] A multicenter, double-blind, comparative study of gabapentin administered as an initial dosage of 900 mg/day versus a dosage titrated to 900 mg/day over three days.

[1995] Evaluation of the efficacy and tolerability of levetiracetam (500mg and 1500mg b.i.d. tablets) add-on treatment in epileptic patients with partial onset seizures.

[1996-2000] A long-term, open-label, multicenter study of the safety and efficacy of levetiracetam 500 mg tablets at individualized oral doses ranging from 1000 mg/day to 4000 mg/day in the treatment of epilepsy.

[1997] Topiramate monotherapy clinical trial in subjects with recently diagnosed partial onset seizures.

[2000] Topamax action of Co-Therapy on tolerability in the clinical setting (TACTICS).

[2003] An assessment of behavioral changes associated with lamotrigine and levetiracetam in patients with epilepsy.

[2006] A Double-blind, randomized conversion to monotherapy comparison of two doses of lamotrigine for the treatment of partial seizures.

PANIC DISORDER

[1992] Fluvoxamine vs. placebo in the treatment of panic disorder.

[2001] A double-blind, placebo-controlled, parallel-group, evaluation of the long-term safety, efficacy and prevention of relapse in adult outpatients with panic disorder who respond to open-label venlafaxine Er.

MIGRAINE

[1989] Multicenter evaluation of the safety and efficacy of subcutaneous sumatriptan in migraine patients.

[1989] Multicenter evaluation of the safety and efficacy of subcutaneous sumatriptan in patients with acute migraine attacks using a two-dose regimen.

[1990] Repeat dose efficacy and safety trial of subcutaneous sumatriptan in migraine patients.

[1991] Evaluation of a combined regimen of subcutaneous and oral sumatriptan in the prevention of migraine recurrence.

[1993-1994] Randomized, double-blind, placebo-controlled, crossover study to evaluate the safety and efficacy of sumatriptan suppositories in the acute treatment of three migraine attacks.

[1993] Efficacy and safety of Dihydroergotamine 2.0 mg and 3.0 mg doses in comparison with placebo for the acute treatment of migraine headache.

[1994-1995] A multicenter, double-blind, randomized, placebo-controlled, parallel group study to confirm the efficacy and safety of zolmitriptan in the treatment of acute migraine headache.

[1995] A multicenter, open study to investigate the long term effects of oral zolmitriptan in the treatment of migraine headache.

[1995] A double-blind, randomized, placebo-controlled study to determine the effectiveness and safety of (Dthydroergotamine Mesylate Nasal Spray 2 mg for the acute treatment of migraine headaches with or without aura in migraineur families.

[1996] A randomized, double-blind, placebo-controlled parallel group, multicenter single-dose, dose-range-finding study to assess the efficacy and tolerability of a novel tetrahydrocarbozole derivative in the acute treatment of migraine.

[1996-1997] Protocol for a multicenter long-term study to maximize migraine relief with zolmitriptan. (MAXIMM).

[1997] Open evaluation of the long-term safety and tolerability of 1.4 mg sc alniditan in the treatment of migraine attacks.

[1997] A randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of alniditan 0.8mg or 1.4mg given subcutaneously in the acute treatment of migraine.

[1997] A randomized, double-blind, placebo-controlled parallel group, multi-center, dose-range­finding study to assess the efficacy, tolerability and safety of VML 251 (administered as a single dose of 0.5 mg, 2.5mg or 5.0 mg) in the acute treatment of migraine.

[1997] A multicenter, randomized, open-label comparative study of the safety, toleration and efficacy of oral Eletriptan for long-term treatment of subjects with acute migraine.

[1997] A multicenter, double-blind, randomized placebo-controlled, parallel group study of the efficacy and safety of escalating dose of oral Eletriptan in subjects with acute migraine.

[1997] A double-blind, randomized trial of two dose ranges of nefazodone and placebo in the prophylactic treatment of migraine.

[1997] A randomized, double-blind, double-dummy, active placebo-controlled, parallel group evaluation of oral sumatriptan (50 mg) compared to oral naproxen sodium (275 mg) on migraine-related quality of life.

[1998] Two period crossover comparison of rizatriptan (5 mg and 10mg p.o.) to sumatriptan (25 mg and 50 mg p.o.) in the acute treatment of migraine.

[1998] A long-term open-label safety study of almotriptan 12.5 mg orally in migraine patients.

[1999] Oral almotriptan vs. oral sumatriptan in a double-blind, randomized, parallel group study of cost-effectiveness and quality of life in migraine.

[2000] A randomized, double-blind, placebo-controlled parallel group evaluation of oral naratriptan 1 mg twice daily as prophylactic treatment for menstrually-associated migraine.

[2000] A multicenter, double-blind, randomized, placebo-controlled parallel group comparative study of the efficacy and safety of oral eletriptan (40 mg) and sumatriptan (100 mg) given for the acute treatment of migraine.

[2001] A double-blind, placebo-controlled, two-attack, cross-over study to assess the efficacy of frovatriptan 2.5 mg taken for mild migraine headache.

[2001] A multicenter, randomized, placebo-controlled, double-blind, parallel-group trial to evaluate the efficacy and tolerability of the zolrnitriptan 5 mg orally disintegrating tablet in the acute treatment of adult subjects with migraine.

[2001] A double-blind, placebo-controlled, three attack cross-over clinical study to assess the safety and efficacy of two dose regimens of frovatriptan in preventing menstrually-associated migraine headaches (MAM).

[2001] A randomized double-blind, placebo-controlled, parallel-groups study to examine the safety, tolerability, and efficacy of rofecoxib 50 and 25 mg for the acute treatment of Migraine.

[2001] A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of MT 300 in subjects with acute migraine attack.

[2001] A multicenter, double-blind, randomized, placebo-controlled, parallel group study of BOTOX ® (botulinum toxin type A) purified neurotoxin complex for the prophylactic treatment of headaches in the chronic headache population.

[2001] An open-label evaluation of the long-term safety of oral naratriptan I mg. twice daily as short-term prophylactic treatment for menstrually-associated migraine.

[2001] A randomized, double-blind, placebo-controlled, single-attack, parallel-group evaluation of the efficacy of sumatriptan 50mg tablets versus placebo in the treatment of self-described and/or physician-diagnosed sinus headaches that meet International Headache Society ([115) criteria for migraine headache.

[2001] A phase Ill, double-blind, randomized, placebo-controlled, parallel-group, multicenter evaluation of civamide (zucapsaicin) nasal solution in the treatment of episodic cluster headache.

[2002] A multicenter, randomized, placebo-controlled, double-blind, parallel-group trial to evaluate early efficacy and tolerability of zohnitriptan (ZOMIG®) Nasal Spray in the acute treatment of adult subjects with migraine.

[2002] An open-label study of eletriptan for the acute treatment of migraine in migraine sufferers who are dissatisfied with rizatriptan therapy

[2002] An open label study for the acute treatment of migraine in migraine sufferers who are dissatisfied with rizatriplan therapy.

[2003] A comparison of the efficacy and safety of topiramate versus placebo for the prophylaxis of chronic migraine (CAPSS-276); phase III).

[2003] A comparison of the efficacy and safety of topiramate versus placebo for the prophylaxis of chronic migraine (CAPSS-276); phase III).

[2004] A double-blind, multicenter, randomized, placebo-controlled single dose study to evaluate the safety and efficacy of TreximaTM in the acute treatment of migraine headaches.

[2005] A multi-center, randomized, double-blind, parallel-group, placebo-controlled, efficacy, safety and tolerability study of dronabinol MDI in the acute treatment of migraine headache.

[2005] Topiramate Intervention to prevent transformation of episodic migraine: the topriamate INTREPID study

[2005] A phase 3, multi-center study evaluating the efficacy of botulinum toxin type a purified neurotoxin complex as headache prophylaxis in migraine patients with 15 or more headache days per 4-week period in a 24-week, double-blind, randomized, placebo-controlled, parallel-group phase followed by a 32-week open-label extension phase.

[2006] A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group multicenter study to evaluate the efficacy and tolerability of sumatriptan succinate/naproxen sodium tablets vs. placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea.

STROKE

[1990] The efficacy and safety of IV ancrod treatment for acute or progressing cerebral ischemic infarction.

[1995] (Nalmefene): Modification of outcome in patients with acute stroke; A double-blind randomized placebo-controlled, parallel group dose comparison study by 24-hour infusion.

[1995] Lubeluzole: Effects of intravenous therapy in subjects with acute ischemic stroke. A placebo-controlled, double-blind, randomized multicenter trial.

[1995] Evaluation of the efficacy and safety of eliprodil hydrochloride in patients with acute ischemic stroke.

[1998] A double-blind parallel group multinational multicenter study of the efficacy and safety of IV clomethiazole compared to placebo in patients with acute ischemic stroke, acute intracerebral hemorrhage, and patients treated with TPA for acute ischemic stroke.

[1998] The effects of 2000 mg citicholine on clinical outcome and the evolution of lesion volume in human stroke.

[2000] A double-blind, randomized, placebo-controlled study of atorvastatin as prevention of cerebrovascular events in patients with a previous transient ischemic attack (TIA) or stroke.

[2003] PRoFESS — Prevention regimen for effectively avoiding second strokes:

A double-blind, active and placebo controlled study of Aggrenox® vs. clopidogrel + aspirin, with and without Micardis®.

Alzheimer’s/Dementia/MCI

[1994] Open-label tacrine study for evaluation of senile dementia.

[1997] An open-label study to evaluate the safety and efficacy of 1.5mg b.i.d. (3 mg/day) through 6mg bid. (12 mg/day) of Exelon in patients with mild to severe probable Alzheimer’s in the community setting.

[2001] Placebo-controlled evaluation of galantamine in the treatment of Alzheimer’s disease: safety and efficacy of a controlled release formulation.

[2001] An open label extension trial to assess the long term safety of a controlled release formulation of Galantamine HBr in the treatment of Alzheimer’s dementia.

[2002] DNAIRNA/SERUM banking in subjects with late onset Alzheimer’s disease.

[2002] DNA/RNA/SERUM banking in subjects with early onset Alzheimer’s disease.

[2003] A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Neramexane in patients with moderate to severe Dementia of the Alzheimer’s Type.

[2003] Psychometric Validation of the Dementia Severity Scale (DSS)

[2003] A randomized, multicenter, double-blind, placebo-controlled, 18 month study of the efficacy of xaliproden in patients with mild-to-moderate dementia of the Alzheimer’s type.

[2004] A randomized double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, and efficacy of titration and treatment with CbS in subjects with middle cognitive impairment (MCI).

[2005] Phase 3 multi-center, randomized, double blind, placebo controlled study of the effect of daily treatment with MPC-7869 on measures of cognitive and global function in subjects with mild to moderate dementia of the Alzheimer’s type.

[2005] An open label evaluation of the safety of memantine in patients with moderate-to-severe dementia of the Alzheimer’s type

[2006] A Double-Blind Placebo-Controlled Study of VP4896 for the Treatment of Mild to Moderate Alzheimer’s disease.

PAIN

[1997] A double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of four doses of intramuscular phenoxybenzamine hydrochloride injection vs. placebo in post injury chronic muscle pain.

[1998] A five-week double-blind, placebo-controlled, parallel group study of pregabalin 75 mg and 150 mg/day in patients with post-herpetic neuralgia.

[1999] An eight-week, randomized, double-blind, placebo-controlled, monotherapy trial of pregabalin for treatment of chronic low back pain.

[1999] An eight-week, randomized, double-blind, placebo-controlled, monotherapy trial of pregabalin for treatment of pain associated with fibromyalgia.

[1999] A pregabalin open-label extension safety trial in patients with post-herpetic neuralgia, chronic low back pain and fibromyalgia.

[2000] An eight-week, double-blind, placebo-controlled parallel group study of pregabalin in patients with post herpetic neuralgia.

[2000] An eight-week, double-blind, placebo-controlled trial of pregabalin (300 mg/day) for relief of pain in patients with painful diabetic peripheral neuropathy.

[2000] A pregabalin, open-label, extension safety trial in patients with post-herpetic neuralgia and painful diabetic peripheral neuropathy (neuropathic pain).

[2000] A randomized, double-blind, placebo-controlled comparison of the safety and efficacy of a novel compound to placebo in subjects with painful diabetic polyneuropathy.

[2000] A comparison of Duragesic and Percocet/oxycodone for the treatment of non-malignant lower back pain.

[2001] A pregabalin (BID) long-term, open-label extension safety trial in patients with neuropathic pain.

[2001] A sustained efficacy study of pregabalin in patients with chronic cervical radiculopathy.

[2001] A double-blind, randomized, parallel-group, placebo-controlled, multiple-dose trial to evaluate the efficacy and safety of 15 and 30 mg extended-release hydrocodone (IICD) in patients requiring chronic opioid therapy for low back pain.

[2001] A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, study to evaluate the efficacy and safety of flexible dosing of levetiracetam at 500 mg to 1500mg b.i.d. in the treatment of subjects with painful diabetic neuropathy.

[2001] A randomized, double-blind placebo controlled trial to investigate safety and efficacy of SPM 927 in painful diabetic neuropathy.

[2001] Multicenter, double-blind, randomized, placebo-control, parallel-group study to evaluate the safety and efficacy of oxcarbazepine in patients with neuropathic pain due to diabetic neuropathy.

[2001] An open-label, randomized, parallel-group active-controlled trial to evaluate the safety and efficacy of extended-release hydrocodone in patients requiring opiates for control of moderate to severe chronic pain.

[2001] A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of 2 different doses of topical cream ketamine/aniifriptyline combination, applied 4 times daily in the treatment of postherpetic neuralgia (PHN).

[2001] A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of 2 different doses of topical cream ketaniine/amitriptyline combination, applied 4 times daily in the treatment of postherpetic neuralgia (PHN).

[2002] LY33353 1 Treatment for Symptomatic Peripheral Neuropathy in Patients with Diabetes

[2002] LY33353 I Treatment of Peripheral Neuropathy in Patients with Diabetes A Phase 3 Pivotal Clinical Trial

[2002] A prospective, open-label, multicenter study of the effectiveness and safety of lidoderm as add-on treatment in patients with postherpetic neuralgia, diabetic neuropathy, or low back pain

[2002] A multicenter, open-label study of the efficacy and safety of EpiCept-NP® topical cream (ketamine/amitriptyline combination) applied 2 times daily in the treatment of postherpetic neuralgia (PHN)

[2003] An open-label tolerability and safety study of oxymorphone extended release in opioid­naïve patients with chronic pain.

[2003] A randomized, multiple-dose, double-blind, placebo-controlled, parallel-group study comparing the safety and efficacy of hydromorphone HCI extended-release and Duragesic® in subjects with non-malignant pain.

[2003] A randomized, double-blind, controlled dose finding study of NGX-40 10 for the treatment of post herpetic neuralgia.

[2003] A randomized, double-blind, controlled dose finding study ofNGX-4010 for the treatment of painful IIIV-associated neuropathy.

[2003] Evaluation of capsaicin cream 0.25% in the treatment of postherpetic neuralgia or painful diabetic neuropathy not controlled by oral anticonvulsant or tricyclic antidepressant medications.

[2003] A phase 2, double-blind, randomized, placebo-controlled, 3-parallel group, multi-center, 12-week study to assess the efficacy and safety of CP-424, 39 1 in Fibromyalgia patients.

[2003] An open-label, long term effectiveness and safety study of Oxymorphone Extended Release (ER) in patients with Cancer or Neuropathic pain.

[2003] A phase IH pivotal, multi-center, double-blind, randomized, placebo-controlled mono­therapy study of Milnacipran for treatment of fibromyalgia.

[2003] A phase 2, double-blind, randomized, placebo-controlled, 3-parallel group, multicenter, 12-week study to assess the efficacy and safety ofCP-424,391 in fibromyalgia patients.

[2004] A multi-center, double-blind, randomized, placebo-controlled, parallel study of the safety and efficacy of BOTOX® (Botulinim Toxin Type A) purified neurotoxin complex in subjects with postherpetic neuralgia.

[2004] Multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy and Safety of 200, 400, and 600MG/day SPM 927 I subjects with painful distal diabetic neuropathy.

[2004] A pilot, randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate the efficacy of Gabapentin and Tramadol in the treatment of small fiber predominant neuropathy.

[2005] A randomized, double-blind, placebo-controlled study of the safety and efficacy of Gabapentin Extended Release (0-ER) tablets in the treatment of patients with postherpetic neuralgia.

[2005] A randomized placebo-controlled trial of the efficacy and safety of Pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.

[2006] A Randomized, Double-Blind, Controlled Study of NGX 4010 For the Treatment of Postherpetic Neuralgia.

[2006] A Multicenter Randomized, Double-Blind, Controlled Study ofNGX-4010 for the Treatment of Painful HIV-Associated Neuropathy.

[2006] A randomized, Double-Blind Study Comparing the Safety and Efficacy of the Lidocaine Patch 5% with placebo in Patients with Pain from Carpal Tunnel Syndrome.

[2006] 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.

[2006] A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial of Pregabalin Twice Daily in Patients with Fibromyalgia.

[2006] A Randomized, Double-Blind, Placebo-controlled, Two-Period Crossover Study to explore the Safety and Preliminary Efficacy of Oral rvlD-XDOCX in the Treatment of Postherpetic Neuralgia.

[2006] A Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Adaptive-Design, Efficacy, Safety and Tolerability Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients with Fibromyalgia Syndrome.

PARKINSON’ S

[2000] A multicenter, double-blind, placebo-controlled study to assess the tolerability and effect of entacapone on the quality of life in Parkinson’ s disease patients treated with levodopa/carbidopa experiencing end-of-dose wearing off.

[2001] A phase III multicenter, double-blind, parallel-group placebo-controlled study of the effect of riluzole 50mg b.i.d. or 100mg BID on the progression of Parkinson’s disease in patients treated with L-dopa or dopamine agonist.

[2001] A phase II double-blind, placebo-controlled, dose-response study of tolerability, safety and efficacy of sumanirole in patients with early Parkinson’s disease.

[2001] An open-label, long-term, flexible dose study of safety, tolerability and therapeutic response of sumanirole in patients with early Parkinson’s disease.

[2001] A multicenter, multinational, phase III, randomized, double blind, placebo controlled trial, of the efficacy and safety of the rotigotine CDS patch in subjects with early stage, idiopathic Parkinson’s disease.

[2001] A multicenter, multinational, phase III, randomized, double-blind, parallel group, placebo controlled trial of the efficacy and safety of rotigotine CDS patch (2 target doses) in subjects with advanced stage, idiopathic Parkinson’s disease who are not well controlled on levodopa (Part I) and open-label extension to assess the safety of long-term treatment of rotigotine CDS (Part II).

[2003] Onset of Motor Complications

[2004] Two double-blind, placebo-controlled, multi-center, multi-national studies (phase ifi) to evaluate the safety and efficacy of Sarizotan in patients with Parkinson’s disease suffering from treatment-related dyskinesia.

[2005] A prospective, multi-center, randomized, open-label study with blinded raters to evaluate the effects of immediate versus delayed switch to Stalevo® on motor function and quality of life in patients with Parkinson’s disease with end-of-dose Wearing off.

[2006] A Randomized, Double-blind, Placebo controlled Parallel-group Fixed and Flexible SLV3O8 Dose Arm Study to Assess Efficacy and Safety of SLV3O8 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease.

MULTIPLE SCLEROSIS

[2002] A randomized, multicenter, parallel group, open-label study comparing the tolerability of Rebif injection with and without the use of RebijectTM Mini therapy in relapsing remitting MS patients.

[2003] A Phase II, randomized, open-label, three-arm study comparing low-and high-dose Campath® (MABCAMPATH® in patients with early, active relapsing-remitting multiple sclerosis.

[2004] A multi-center, randomized, single-blind, parallel group study to compare the efficacy, tolerability and safety, of Copaxone® to that of high dose Interferon (Betaseron® or Rebif®) in the treatment of relapsing Multiple Sclerosis patients.