Trial Outcomes & Findings for Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI (NCT NCT00243152)

Last Updated: 2018-12-07

Results Overview

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\*\* Cortical, subcortical, and brain stem sensory regions Z-scores Increase or decrease in activation as affected by the drug

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Week 10 during scanning session

Results posted on

2018-12-07

Participant Flow

This study recruited adult males and females ages 18 to 60 with diagnosed facial neuropathic pain.

Participant milestones

Participant milestones
Measure	Lamotrigine to Placebo Crossover The drug lamotrigine taken 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, provided during both arms of the study for pain control. Patients taper off the Gabapentin 2 weeks before each scan date. After a taper and washout period placebo (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for 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. Lamotrigine: : 25mg and 50mg tablets	Placebo to Lamotrigine Crossover Placebo is taken 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, provided during both arms of the study for pain control. Patients taper off the Gabapentin 2 weeks before each scan date. After a taper and washout period the drug, Lamotrigine (cross over), will be administered. At the end of the trial (after imaging session 2), a taper for drug 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.
Overall Study STARTED	3	3
Overall Study Scan 1: Drug or Placebo	3	3
Overall Study Scan 2: Placebo or Drug	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lamotrigine n=6 Participants 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. Lamotrigine: : 25mg and 50mg tablets
Age, Customized Ages 18 to 60 Years	6 participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Diagnosed with facial pain	6 participants n=5 Participants
Continuous pain for more than 3 months	6 participants n=5 Participants
Spontaneous pain greater than 3 of 10	6 participants n=5 Participants
Allodynia brush greater than 5 of 10	6 participants n=5 Participants
Right-handed	6 participants n=5 Participants
Non-smokers	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 10 during scanning session

Population: The data's primary comparisons no longer exists per intervention.

Outcome measures

Outcome measures
Measure	Lamotrigine vs Placebo n=6 Participants The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. Placebo will be administered in another imaging session. 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.	Lamotrigine The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. 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. Lamotrigine: : 25mg and 50mg tablets
Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States Heat Affected Thalamus (10,-14,8)	-2.9294 Z-statistic	—
Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States Heat Affected Post-Central (-56,-12,28)	-2.7323 Z-statistic	—
Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States Cold Affected Post-Central (68, -8, 32)	-2.5114 Z-statistic	—
Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States Cold Affected Thalamus (-4, -8, 0)	-3.033 Z-statistic	—
Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States Brush Affected Post-Central (66,-16,14)	3.905 Z-statistic	—
Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States Brush Affected Thalamus (-14,-22, 4)	-3.791 Z-statistic	—
Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States Brush Affected Spinal Trigeminal Nucles(2,-48,-68)	2.9058 Z-statistic	—

SECONDARY outcome

Timeframe: week 10 (during the scan)

Quantitative Sensory Testing (QST) Stimuli Type: Heat, Cold, Brush Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Ratings on a likert scale of 0-10 with 0 being defined as no pain and 10 being defined as worst possible pain

Outcome measures

Outcome measures
Measure	Lamotrigine vs Placebo n=6 Participants The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. Placebo will be administered in another imaging session. 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.	Lamotrigine n=6 Participants The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. 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. Lamotrigine: : 25mg and 50mg tablets
Subjective Ratings of Pain During Magnetic Resonance Scanning Heat Affected	5.5 scores on a pain scale Standard Deviation 2	3.2 scores on a pain scale Standard Deviation 1.5
Subjective Ratings of Pain During Magnetic Resonance Scanning Heat Unaffected	4 scores on a pain scale Standard Deviation 3	3 scores on a pain scale Standard Deviation 2
Subjective Ratings of Pain During Magnetic Resonance Scanning Cold Affected	2.5 scores on a pain scale Standard Deviation 1.2	2.1 scores on a pain scale Standard Deviation 1.5
Subjective Ratings of Pain During Magnetic Resonance Scanning Cold Unaffected	1.1 scores on a pain scale Standard Deviation 1	2.2 scores on a pain scale Standard Deviation 1.75
Subjective Ratings of Pain During Magnetic Resonance Scanning Brush Affected	3.9 scores on a pain scale Standard Deviation 2.1	2.8 scores on a pain scale Standard Deviation 2.8
Subjective Ratings of Pain During Magnetic Resonance Scanning Brush Unaffected	.4 scores on a pain scale Standard Deviation .3	1.2 scores on a pain scale Standard Deviation 2.2

Adverse Events

Lamotrigine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Borsook

Boston Children's Hospital

Phone: 617-281-7135

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place