N/A N=6 Randomized Double-blind Treatment

Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

Facial Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT00243152 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States — -2.9294; -2.7323; -2.5114; -3.033 Z-statistic

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lamotrigine (Drug); Placebo (for Lamotrigine) (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Pain and Analgesia Imaging and Neuroscience Group
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States	-2.9294; -2.7323; -2.5114; -3.033; 3.905; -3.791	—
SECONDARY Subjective Ratings of Pain During Magnetic Resonance Scanning	5.5; 3.2; 4; 3; 2.5; 2.1	<0.05 sig

Summary

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00243152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.