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Trial record 31 of 215 for:    Lamotrigine

Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

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ClinicalTrials.gov Identifier: NCT00243152
Recruitment Status : Completed
First Posted : October 21, 2005
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
David Borsook, M.D., Ph.D., Pain and Analgesia Imaging and Neuroscience Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Facial Neuropathy
Interventions Drug: Lamotrigine
Drug: Placebo (for Lamotrigine)
Enrollment 6
Recruitment Details This study recruited adult males and females ages 18 to 60 with diagnosed facial neuropathic pain.
Pre-assignment Details  
Arm/Group Title Lamotrigine to Placebo Crossover Placebo to Lamotrigine Crossover
Hide Arm/Group Description

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 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.
Period Title: Overall Study
Started 3 3
Scan 1: Drug or Placebo 3 3
Scan 2: Placebo or Drug 3 3
Completed 3 3
Not Completed 0 0
Arm/Group Title Lamotrigine
Hide Arm/Group Description

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

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
Both male and female adults ages 18 to 60 years old who are right-handed and non-smokers. Participants must be diagnosed with facial pain that has been continuous for more than 3 months. Their spontaneous pain must be great than 3 of 10 and their allodynia to brush must be greater than 5 of 10.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Ages 18 to 60 Years Number Analyzed 6 participants
6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
Diagnosed with facial pain  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
6
Continuous pain for more than 3 months  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
6
Spontaneous pain greater than 3 of 10   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
6
[1]
Measure Description: Pain Scale Description: 0-10 rating scale where 0 indicates no pain and 10 indicates the highest pain
Allodynia brush greater than 5 of 10   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
6
[1]
Measure Description: Pain Scale Description: 0-10 rating scale where 0 indicates no pain and 10 indicates the highest pain
Right-handed  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
6
Non-smokers  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
6
1.Primary Outcome
Title Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States
Hide Description 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
Time Frame Week 10 during scanning session
Hide Outcome Measure Data
Hide Analysis Population Description
The data's primary comparisons no longer exists per intervention.
Arm/Group Title Lamotrigine vs Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Z-statistic
Heat Affected Thalamus (10,-14,8) -2.9294
Heat Affected Post-Central (-56,-12,28) -2.7323
Cold Affected Post-Central (68, -8, 32) -2.5114
Cold Affected Thalamus (-4, -8, 0) -3.033
Brush Affected Post-Central (66,-16,14) 3.905
Brush Affected Thalamus (-14,-22, 4) -3.791
Brush Affected Spinal Trigeminal Nucles(2,-48,-68) 2.9058
2.Secondary Outcome
Title Subjective Ratings of Pain During Magnetic Resonance Scanning
Hide Description

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

Time Frame week 10 (during the scan)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:

The placebo 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. 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.

Placebo (for Lamotrigine): Sugar pill manufactured to mimic Lamotrigine tablets

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

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: scores on a pain scale
Heat Affected 5.5  (2) 3.2  (1.5)
Heat Unaffected 4  (3) 3  (2)
Cold Affected 2.5  (1.2) 2.1  (1.5)
Cold Unaffected 1.1  (1) 2.2  (1.75)
Brush Affected 3.9  (2.1) 2.8  (2.8)
Brush Unaffected .4  (.3) 1.2  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lamotrigine
Comments Visual analog scale (VAS) ratings in the scanner. Measures of pain ratings to evoked stimuli during scanning for heat applied to the affected side.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lamotrigine
Comments VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for heat applied to the unaffected side.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lamotrigine
Comments VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the affected side.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Lamotrigine
Comments VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the unaffected side.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Lamotrigine
Comments VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the affected side.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Lamotrigine
Comments VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the unaffected side.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description

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

The placebo 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. 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.

Placebo (for Lamotrigine): Sugar pill manufactured to mimic Lamotrigine tablets

All-Cause Mortality
Lamotrigine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lamotrigine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Every effort was made to obtain the data presented in outcome measure 2. However only the data in the publication is available, estimates were made based on the figures.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Borsook
Organization: Boston Children's Hospital
Phone: 617-281-7135
EMail: david.borsook@childrens.harvard.edu
Layout table for additonal information
Responsible Party: David Borsook, M.D., Ph.D., Pain and Analgesia Imaging and Neuroscience Group
ClinicalTrials.gov Identifier: NCT00243152     History of Changes
Other Study ID Numbers: Facial Neuropathy/lamotrigine
First Submitted: October 19, 2005
First Posted: October 21, 2005
Results First Submitted: November 12, 2014
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018