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Information for helping to manage pain.

Dr. John Kelly

LICENSURES

Licensed in Kentucky

BOARD CERTIFICATIONS

Diplomate, National Board of Medical Examiners

Diplomate, American Board of Pyschiatry and Neurology

Certification in Neurosonology

American Society of Neuroimaging

Basic Cardiac Life Support Provider

Advanced Cardiac Life Support Provider

Advanced Cardiac Life Support Instructor

EDUCATION AND TRAINING

Medical School - University of Colorado Health Sciences Center

Fellowship- Neuro-oncology and Pain Management, University of Cincinnati Hospital and VA Hospital of Cincinnati 1990-1991

Residency-Neurology North Carolina Baptist Hospital Bowman-Gray School of Medicine Wake Forest University 1987-1990

Internship-Internal Medicine North Carolina Baptist Hospital Bowman-Gray School of Medicine Wake Forest University 1987-1990

Other postgraduate Training- Minifellowship in Epilepsy Graylyn Conference Center December 1988

Neurovascular Sonology Course Bowman-Gray School of Medicine 1990

Neurosonology Certification Course American Society of Neuroimaging 1990

CLINCAL DRUG TRIALS

Protocol for an open, marketing study of DuragesicTM (transdermal fentanyl system) in patients with chronic cancer pain.  Janssen Research Foundation, Protocol number 4263/0101. October 1990.  Sub-investigator.

A randomized double-blind placebo-controlled parallel multi-center phase III study of epidural clonidine for the treatment of pain associated with advanced cancer.  Lyphomed EC-001.  January 1991. Co-investigator.

Assessment of the efficacy and safety of alteplase (tissue plasminogen activator) in the treatment of acute ischemic stroke.  NINDS Stroke Trial.  July 1993.  Co-investigator.

A randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of four doses of oral naratriptan in the acute treatment of a single migraine attack. Glaxo protocol S2WA3001.  July 1995. Principal Investigator.

Assessment of the efficacy and safety of Eliprodil in patients with acute ischemic stroke.  Lorex protocol LES02.  July 1995.  Principal Investigator.

A study to evaluate the pharmacokinetics and pharmacodynamics of oral naratriptan in migraine subjects.  Glaxo protocol S2WA1007.  January 1996.  Principal Investigator

A double-blind, double-dummy, parallel-group comparison of lamotrigine and divalproex sodium monotherapy in patients with generalized seizures.  Glaxo Wellcome protocol SCAA4001.  May 1996.  Principle Investigator.

A double-blind, placebo-controlled, randomized, crossover study to rechallenge patients who previously experienced an adverse event involving chest discomfort or pain following oral naratriptan administration.  GlaxoWellcome protocol S2WA2005. July 1996.  Principal Investigator.

A randomized, double-blind, placebo-controlled study to evaluate the impact of sumatriptan injection on workplace productivity loss due to migraine.  GlaxoWellcome protocol SUMA4015.  July 1996.  Principal Investigator.

Morphine with dextromethorphan versus morphine in chronic cancer pain.  Algos protocol 49774-008.  March 1997. Co-Investigator.

An open, randomized, multi-center study to assess the efficacy and safety of 1.25mg QD and 10mg QD Zydis selegiline in the control of symptoms of Parkinson’s Disease in patients stabilized on a regimen including selegiline.  Scherer Protocol NO: Z/SEL/95/008.  May 1997.  Principle Investigator.

Phase 2 study of Hu23F2G in acute exacerbations of multiple sclerosis.  ICOS corporation protocol A96002i.  July 1997.  Principle Investigator.

A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of oral naratriptan (2.5mg) for the treatment of migraine in subjects who do not respond to oral sumatriptan (50mg).  GlaxoWellcome Protocol No: S2WA4002.  August 1997.  Principal Investigator.

Protocol for a multi-center, randomized, double-blind, placebo-controlled, parallel group, in-clinic study to investigate the efficacy and tolerability of intravenous 4991W93 in the acute treatment of a single migraine headache.  GlaxoWellcome Protocol No: CIAA2001.  September 1997.  Principal Investigator.

A randomized, double-blind, parallel-group study to compare the safety and efficacy of Zydis selegiline 1.25mg QD to 2.5 mg Q.D. with placebo as an adjunct in the management of Parkinsonian patients being treated with levodopa who exhibit deterioration in the quality of their response to this therapy.  Scherer Protocol NO: Z/SEL/97/026.  Dec 1997.  Principle Investigator.

The Safety and Efficacy of Combination Therapy Using ProsynapÔ (labeluzole) and ActivaseÒ (t-PA) in Ischemic Stroke.  Janssen Research Foundation Protocol No: LUB-USA-6.  December 1997.  Co-Investigator.

Metrifonate Investigational Nationwide Trial (M.I.N.T.).  Bayer Corporation Protocol No: D97-019.  March 1998.  Principle Investigator.

A Double Blind Randomized, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of 4 Doses of Intramuscular Phenoxybenzamine Hydrochloride Injection versus Placebo in Chronic Muscle Pain.  Berlex Laboratories Protocol No: 07040.  April 1998.  Principle Investigator.

Abciximab (ReoProÔ) in Acute Ischemic Stroke: A Randomized, Double-Blind, Placebo-Controlled, Phase II, Dose-Escalation Study.  Centocor Inc Protocol No: C0116T30.  October 1997.  Co-Investigator.

An Open-Label, Long-term Observational Study of the Safety and Tolerability of Sumatriptan Nasal Spray in the Treatment of Migraine in Adolescents GlaxoWellcome Inc Protocol SMART SUM40276

January 1998. Principal Investigator.

A Randomized, Double-Blind, Parallel-Group Study to Compare the Safety and Efficacy of Zydis Selegiline 1.25mg to 2.5mg QD with Placebo as an Adjunct in the Management of Parkinsonian Patients Being treated with Levodopa who Exhibit Deterioration in the Quality of their response to this Therapy. Scherer DDS (Elan Pharmaceutical) Protocol Z/SEL/97/026.  January 1998. Principal Investigator.

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety Study of 4 Doses of Intramuscular Phenoxybenzamine Hydrochloride Injection versus Placebo in Post-Injury Chronic Muscle Pain.  Berlex Laboratories Protocol 97040.  March 1998. Principal Investigator.

A Double-Blind, Placebo-Controlled, Dose-Determination, Safety, Tolerability and Efficacy Study of Intravenous Antegren In Patients with Multiple Sclerosis During An Acute Exacerbation.  Athena Neuroscience Elan Pharmaceuticals Protocol Antegren AN100226-202.  March 1998. Principal Investigator.

An Open Extension Study of the Safety and Efficacy of Zydis Selegiline 1.25mg to 2.5mg Q.D. as an Adjunct in the Management of Parkinsonian Patients Being Treated with Levodopa.  Elan PharmaceuticalZ/SEL/97/027.  April 1998. Principal Investigator.

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study in Patients with Partial Seizures.  Parke Davis Protocol 1008-034 & 1008-035.  October 1998. Principal Investigator.

Open Randomized Comparison of Add-on Lamotrigine or Valproate/Carbamazepine withdrawing to Monotherapy in Patients with Treatment Resistant Epilepsy.  GlaxoWellcome Inc Protocol SCAB3001.  October 1998. Principal Investigator.

Placebo Controlled, Double-Blind Study of the Safety, Tolerability, and Efficacy of the Selegiline Transdermal System (STS) in Parkinson’s Disease Patients Experiencing Sub-Optional Responses to Levodopa/Carbidopa.  Somerset Pharmaceuticals Inc Protocol S9303-E109-97B.  October 1998. Principal Investigator.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of oral Naloxone for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Malignant or Malignant Pain.  Roxane Laboratories Protocol NAL-0397.  November 1998. Principal Investigator.

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Groups Study of Morphelan (Morphine Sulfate oral extended release capsules) in Patients with Chronic, Moderate to Severe Pain.  Elan Pharmaceuticals Protocol TARG 004-02.  November 1998. Principal Investigator.

A 4 week, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study to Evaluate the Safety, Tolerability and efficacy of three dose levels of Prosaptide TX14(A) when administer daily for 28 days by Subcutaneous Injection on Diabetic Painful/Neuropathy in patients with Type 1 or Type 2 Diabetes Mellitus.  Myelos Neurosciences Corp Protocol TX14-004.  December 1998. Principal Investigator.

A Multicenter, Non-Randomized, Open-Extension Study of Morphelan (Morphine Sulfate oral Extended release capsules) in Patients with Chronic, Moderate to Severe Pain Who Have Completed A Prior Morphelan Clinical Trial. Elan Pharmaceuticals Protocol TARG 004-03.  January 1999. Principal Investigator.

A Randomized, Double-Blind, Repeated-Dose, Parallel-Group Comparison of the Efficacy and Tolerability of Dilaudid SR tablets and Immediate Release Dilaudid Tablets (Hydromorphone HCL) in Patients with Chronic Pain.  Knoll Pharmaceutical Company Protocol DO – 109.  March 1999. Principal Investigator.

A Randomized, Double-Blind, Repeated-Dose, Parallel-Group Comparison of the Efficacy and Tolerability of Dilaudid SR tablets and Immediate-Release Dilaudid Tablets (Hydromorphone HCL) in Patients with Chronic Pain.  Knoll Pharmaceutical Protocol DO – 119.  March 1999. Principal Investigator.

Blockade of the GPIIB/IIIA Receptor to Avoid Vascular Occlusion (BRAVO) SmithKline Beecham Pharmaceuticals Protocol SB214857/030.  April 1999. Principal Investigator.

An Open-Label Study of the Long-Term Safety and Tolerability of the Selegiline Transdermal System in Patients with Parkinson’s Disease.  Somerset Pharmaceuticals Inc Protocol S9303-P9917.  May 1999. Principal Investigator.

A Randomized, Double-Blind, Parallel Group, Monotherapy Study To Compare The Safety and Efficacy of Two Doses of Topiramate In the Treatment of Newly Diagnosed or Recurrent Epilepsy.  RW Johnson Pharmaceuticals. PRI/TOP-INT-28. Sept 1999.  Principal Investigator.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Tolerability and Efficacy of 12 week Oral GV196771 300mg Once Daily Compared to Placebo in the Prophylaxis of Migraine Headache Attacks in Adult Subjects with Migraine.  GlaxoWellcome Protocol GL230016.  October 1999.  Principal Investigator.

A Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of Topiramate Versus Placebo in the Relief of Pain in Diabetic Peripheral Polyneuropathy.  RW Johnson Pharmaceuticals Protocol TOPMAT-NP-001. October 1999. Principal Investigator.

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of Oral Naratriptan 1mg Twice Daily as Prophylactic Treatment for Menstrually-Associated Migraine.  GlaxoWellcome Protocol S2W40012 (DB).  December 1999. Principal Investigator.

An Open-Label, Long-Term Safety and Tolerability Study of Ziconotide Administered Intrathecally to Patients with Chronic, Severe Pain.  Elan Pharmaceuticals Protocol 98-022.  February 2000. Principal Investigator.

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel Group, Clinical Study of the Safety and Efficacy of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Injections into Areas of Focal Tenderness in Subjects with chronic low back pain.  Allergan Inc Protocol 191622-013 BOTOX.  February 2000. Principal Investigator.

Pilot MRI Study of PEG-Intron (SCH 54031) in Ambulatory Subjects with Relapsing Multiple Sclerosis.  Schering-Plough Protocol P00190.  February 2000.  Sub-Investigator.

AN Open-Label Evaluation of the Long-Term Safety of Oral Naratriptan 1mg Twice Daily as Short-Term Prophylactic Treatment for Menstrually-Associated Migraine.  GlaxoWellcome Protocol S2W40027 (OL).  April 2000.  Principal Investigator.

A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen tablets in patients with chronic back pain.  Purdue Pharma Protocol BP98-1201.  June 2000. Principal Investigator.

An Open-Label, Repeated-Dose Trail to Characterize the Efficacy and Safety, and Impact on Quality of Life Measures of Dilaudid CR (Hydromorphone HCL) in Patients with Chronic Low Back Pain.  Knoll Pharmaceuticals Protocol D0-127 OL.  June 2000. Principal Investigator.

Safety, Efficacy, and Impact On Quality of Life of Long-Term Administration of Dilaudid CR (Hydromorphone HCL) in Patients with Chronic Low Back Pain. Knoll Pharmaceutical Company Protocol DO – 127 EXT.  June 2000. Principal Investigator.

Double-Blind, Randomized, Parallel-Group, Placebo Controlled Trial to evaluate the efficacy and safety of Hydromorphone Hydrochloride Extended-Release 12mg capsules Compared to Placebo in Patients with Osteoarthritis who have Moderate to Severe Pain.  Purdue Pharma Protocol HMP-3005.  August 2000.  Principal Investigator.

A Randomized, Bouble-Blind, Placebo-Controlled, Parallel Group, Single-Attack Evaluation of Sumatriptan 50 mg and 100 mg versus Placebo During a Migraine Headache at the First Sign of Pain.  GlaxoWellcome Inc.\ Protocol S2W40275.  August 2000. Principal Investigator.

Olmapatrilat Cardiovascular Treatment Assessment Versus Enalapril.  Bristol-Meyers Protocol OCTAVE CV 137-120.  October 2000. Principal Investigator.

OTHER RESEARCH ACTIVITIES

Kelly JB, Payne R, Privitera M, Moran K: Clinical features and treatment of headache associated with invasive intracranial epilepsy monitoring. 1991

Kelly JB, Payne R: Base of skull metastasis in prostate carcinoma.  1992

PUBLICATIONS

Filley CM, Kelly JB, Heaton RK, Neuropsychological Features of Early- and Late- Onset Alzheimer’s Disease, Arch Neurol 43:574-76, 1986

Filley CM, Davis KA, Schmitz SP, Stears JC, Heaton RK, Kelly JB, Culig KM, Scherzinger AL, Neuropsychological Performance and Magnetic Resonance Imaging In Alzheimer’s Disease and Normal Aging, Neuropsychiatry, Neuropsychology, and Behavioral Neurology, 2:2:81-91, 1989

Kelly JB, Payne R: Pain Management in the Elderly.  In: Clinical Geriatric Neurology, Laurie Barclay, editor , Lea & Febiger, Philadelphia, 1993.

Kelly JB, Payne R: Cancer Pain Syndromes.  In Neurologic Clinics of North America, November, 1991

Kelly JB, Gonzales GR; Treatment of cancer pain in the abuse-prone patient.  Primary Care and Cancer, November, 1991

Douglas MD, Garland WT, Kelly JB, et al, Efficacy of Once-Daily, Rapid-Onset, Extended-Release Morphine Sulfate Formulation (Morphelan ROER) and Twice-Daily Morphine Sulfate Controlled-Release Formulation (MS Contin) in Patients with Chronic, Moderate-to-Severe Pain. Presented at the American Pain Society Annual Meeting, April 19-22, 2001.  J Pain 2001; 2(2 Suppl 1):40.  Abstract #780

POSTER PRESENTATIONS

Nickles TP, Donofrio PD, Pugh JE, Kelly JB:  Sensory Neuronopathy Associated with Sjogren’s Syndrome: Evidence for a Humoral Immune Mechanism.  American Academy of Neurology Annual Meeting, April 1990

Kelly JB, Payne R, Privitera M: Headache Associated With Invasive Epilepsy Monitoring.  American Academy of Neurology Annual Meeting, April 1991

GRANTS AWARDED

Kelly JB, Payne R: Clinical Pharmacology of Analgesic Drugs.  Veteran’s Administration Office of Academic Affairs.  August 1990.

AFFILIATIONS
American Medical Association

Ohio State Medical Society

American Academy of Neurology

American Society of Neuroimaging

American Pain Society

American Association for Study of Headache