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Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
This study has been completed.
Study NCT00243152   Information provided by Pain and Analgesia Imaging and Neuroscience Group
First Received: October 19, 2005   Last Updated: February 3, 2009   History of Changes

October 19, 2005
February 3, 2009
October 2005
July 2008   (final data collection date for primary outcome measure)
blood oxygenation level-dependent (BOLD) changes in neural pain circuitry following treatment with lamotrigine during experimentally induced pain states
Same as current
Complete list of historical versions of study NCT00243152 on ClinicalTrials.gov Archive Site
subjective ratings of pain during MR scanning
Same as current
 
Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fMRI).

Currently there are no pharmacological agents that can control neuropathic pain akin to the efficacy of antibiotics for bacterial infection. All current neuropathic pain drugs have approximately the same efficacy of less than 30% in controlled trials, and many of these drugs do not have known mechanisms of action. fMRI studies may provide insight into how brain circuitry is altered by chronic pain, and how these drugs act on altered circuitry. The trigeminal system in particular offers unique advantages for studying such alterations, including a large central representation and high degree of somatotopy. The administration of lamotrigine to neuropathic pain patients in conjunction with fMRI will allow us to compare subjective ratings of pain with objective measures of neural activity during increased conditions of allodynia/hyperalgesia.
 
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Facial Neuropathy
Drug: lamotrigine: 25mg and 50mg tablets
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-60 years of age
  • Right-handed non-smokers
  • Diagnosed with facial pain
  • Continuous pain for more than 3 months
  • Spontaneous pain greater than 3 of 10
  • Allodynia to brush greater than 5 of 10

Exclusion Criteria:

  • Medications
  • Depression
  • Significant medical problems
  • Claustrophobia
  • Abnormal EKG
  • Significant drug or alcohol history
  • Positive drug screen
  • Weight greater than 285 lbs
  • History of allergy to anticonvulsants
  • Tattoos with metallic ink on upper body
  • Any neurostimulator devices, or metal cochlear, ocular, or cardiac implants or other metal near vital areas
  • Exposure to shrapnel or metal filings
  • Other metallic surgical hardware
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00243152
David Borsook, McLean Hospital
Facial Neuropathy/lamotrigine
Pain and Analgesia Imaging and Neuroscience Group
GlaxoSmithKline
Principal Investigator: David Borsook, M.D., Ph.D. Mclean Hospital
Pain and Analgesia Imaging and Neuroscience Group
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP




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