Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
David Borsook, M.D., Ph.D., Pain and Analgesia Imaging and Neuroscience Group
ClinicalTrials.gov Identifier:
NCT00243152
First received: October 19, 2005
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention
Facial Neuropathy
Drug: Lamotrigine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

Resource links provided by NLM:


Further study details as provided by Pain and Analgesia Imaging and Neuroscience Group:

Primary Outcome Measures:
  • blood oxygenation level-dependent (BOLD) changes in neural pain circuitry following treatment with lamotrigine during experimentally induced pain states [ Time Frame: 75-90 (mins relative to start) Anatomical Scan, 90-150 fMRI ] [ Designated as safety issue: No ]
    fMRI scans acquired Stimuli Type: Brush Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness fMRI scans acquired Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning** fMRI scans acquired Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning**


Secondary Outcome Measures:
  • subjective ratings of pain during MR scanning [ Time Frame: 65-75- Quantitative Sensory Testing, 105-110, 125-130, 145-150 (minutes relative to start) ] [ Designated as safety issue: No ]

    QST (Quantitative Sensory Testing) Thresholds

    Stimuli Type: Brush Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness



Enrollment: 6
Study Start Date: October 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lamotrigine
The drug lamotrigine or placebo will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided during both arms of the study for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout period lamotrigine or placebo (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for drug/placebo will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.
Drug: Lamotrigine
: 25mg and 50mg tablets
Other Names:
  • LAMO
  • LAM

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243152

Locations
United States, Massachusetts
McLean Hospital Neuroimaging Center, 115 Mill Street
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Pain and Analgesia Imaging and Neuroscience Group
GlaxoSmithKline
Investigators
Principal Investigator: David Borsook, M.D., Ph.D. Mclean Hospital
  More Information

Additional Information:
Publications:
Responsible Party: David Borsook, M.D., Ph.D., Dr., Pain and Analgesia Imaging and Neuroscience Group
ClinicalTrials.gov Identifier: NCT00243152     History of Changes
Other Study ID Numbers: Facial Neuropathy/lamotrigine
Study First Received: October 19, 2005
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pain and Analgesia Imaging and Neuroscience Group:
pain
neuropathic
face
trigeminal

Additional relevant MeSH terms:
Facies
Facial Pain
Facial Nerve Diseases
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cranial Nerve Diseases
Lamotrigine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on September 30, 2014