NCT00243152

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
10.4 years until next milestone

Results Posted

Study results publicly available

December 7, 2018

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

2.8 years

First QC Date

October 19, 2005

Results QC Date

November 12, 2014

Last Update Submit

December 6, 2018

Conditions

Facial Neuropathy

Keywords

painneuropathicfacetrigeminal

Outcome Measures

Primary Outcomes (1)

  • Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States

    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

    Week 10 during scanning session

Secondary Outcomes (1)

  • Subjective Ratings of Pain During Magnetic Resonance Scanning

    week 10 (during the scan)

Study Arms (2)

Lamotrigine to Placebo Crossover

ACTIVE COMPARATOR

The drug lamotrigine will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, 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.

Drug: Lamotrigine

Placebo to Lamotrigine Crossover

ACTIVE COMPARATOR

The placebo will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, 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.

Drug: Placebo (for Lamotrigine)

Interventions

LamotrigineDRUG

: 25mg and 50mg tablets

Also known as: LAMO, LAM
Lamotrigine to Placebo Crossover
Placebo (for Lamotrigine)DRUG

Sugar pill manufactured to mimic Lamotrigine tablets

Also known as: Placebo
Placebo to Lamotrigine Crossover

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital Neuroimaging Center, 115 Mill Street

Belmont, Massachusetts, 02478, United States

Location

Related Publications (4)

  • Becerra L, Breiter HC, Wise R, Gonzalez RG, Borsook D. Reward circuitry activation by noxious thermal stimuli. Neuron. 2001 Dec 6;32(5):927-46. doi: 10.1016/s0896-6273(01)00533-5.

    PMID: 11738036BACKGROUND

  • Zakrzewska JM, Chaudhry Z, Nurmikko TJ, Patton DW, Mullens LE. Lamotrigine (lamictal) in refractory trigeminal neuralgia: results from a double-blind placebo controlled crossover trial. Pain. 1997 Nov;73(2):223-230. doi: 10.1016/S0304-3959(97)00104-8.

    PMID: 9415509BACKGROUND

  • Petersen KL, Maloney A, Hoke F, Dahl JB, Rowbotham MC. A randomized study of the effect of oral lamotrigine and hydromorphone on pain and hyperalgesia following heat/capsaicin sensitization. J Pain. 2003 Sep;4(7):400-6. doi: 10.1016/s1526-5900(03)00718-1.

    PMID: 14622682BACKGROUND

  • Scrivani S, Wallin D, Moulton EA, Cole S, Wasan AD, Lockerman L, Bajwa Z, Upadhyay J, Becerra L, Borsook D. A fMRI evaluation of lamotrigine for the treatment of trigeminal neuropathic pain: pilot study. Pain Med. 2010 Jun;11(6):920-41. doi: 10.1111/j.1526-4637.2010.00859.x. Epub 2010 May 11.

    PMID: 20492571RESULT

Related Links

MeSH Terms

Conditions

Facial Nerve DiseasesPainFacies

Interventions

Lamotriginelipoarabinomannan

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

TriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. David Borsook
Organization
Boston Children's Hospital
david.borsook@childrens.harvard.edu
617-281-7135

Study Officials

  • David Borsook, M.D., Ph.D.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 21, 2005

Study Start

October 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

December 7, 2018

Results First Posted

December 7, 2018

Record last verified: 2018-12

Locations

US(1)