Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203229
First received: September 13, 2005
Last updated: January 22, 2009
Last verified: January 2009
  Purpose

This research study will look at the safety (e.g., the occurrence of side effects) and efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called lamotrigine in adults with trigeminal neuralgia.


Condition Intervention
Trigeminal Neuralgia
Drug: Lamotrigine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo Controlled Add-on Study to Determine the Efficacy and Safety of Lamictal (Lamotrigine) in Patients With Trigeminal Neuralgia (Tic Doloureux)

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Estimated Enrollment: 38
Study Start Date: June 2003
Detailed Description:

A randomized, double-blind, placebo-controlled, add-on study of lamotrigine in trigeminal neuralgia. Thirty-eight eligible patients with trigeminal neuralgia will be enrolled; nineteen will be randomized to the active medication group and nineteen to the placebo group. Using a daily diary, all patients will document their overall pain level and attack frequency and intensity for four weeks. After the four week baseline period, patients will initiate medication (lamotrigine or placebo). Patients will titrate until either they reach the maximum dose of 400mg per day and up to 700mg for patients on enzyme-inducing anti-epileptic drugs (EIAED's), their side effects inhibit further increases (known as maximum tolerated dose (MTD)), or their trigeminal neuralgia pain resolves (referred to as pain free dose (PFD)) over eight weeks. Patients will remain on a constant dose of prior medications throughout the study. Patients will remain on maximum dose, MTD, or PFD for a maintenance period of at least eight weeks, and at the end of the maintenance period patients who opt to stay on the medication will be unblinded as to medication and dosage. Primary outcome will be average intensity of daily pain. Secondary outcome measures will be attack intensity and frequency. Subject Global Assessment and SF-36 Health Surveys will also be followed.

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 75 yrs
  • Male; or non-pregnant/non-lactating female
  • Use of adequate birth-control measures as determined by investigator for females of child-bearing potential
  • Diagnosis of TN using IHS criteria (see appendix A)
  • Able to cooperate with and understand study instructions
  • Signed informed consent prior to entering study
  • Patients must be on a stable dose of concomitant medications for treatment of TN for at least 4 weeks (see below)
  • If subject is currently receiving a tricyclic antidepressant, anticonvulsant, and/or Class I antiarrhythmic (e.g., amitriptyline, mexiletine, phenytoin, gabapentin or carbamazepine) for treatment of pain or any other condition, subject must be willing and able to maintain stable doses of these agents within 4 weeks prior to randomization and throughout the study (i.e., doses cannot be increased or decreased during this period).
  • Subjects who require "rescue" analgesic medication during the study will be allowed to use increased doses of their current (pre-study) opioid and/or non opioid analgesics as clinically indicated (e.g., NSAIDs, acetaminophen, COX-2 inhibitors, topical analgesics). Subjects will be allowed to use a new analgesic for a limited time for non-neuropathic pain (e.g., headache, sinusitis, strained muscle, minor ache and pain), but will be prohibited from initiating therapy with a new analgesic agent and use it continuously throughout the remainder of the study.
  • If subject is not currently receiving a tricyclic antidepressant, anticonvulsant, and/or Class I antiarrhythmic (e.g., amitriptyline, mexiletine, phenytoin, gabapentin or carbamazepine) for treatment of pain or any other condition, subject must be willing and able to abstain from initiation of these agents within 4 weeks prior to randomization and throughout the study.
  • Subject must be willing and able to abstain from initiating an alternative therapy (e.g., acupuncture, massage or physical therapy) for pain relief during the study. (NOTE: subjects who are currently using alternative therapy for pain relief can be enrolled if they are willing and able to maintain such therapy stable throughout the study.)

Exclusion Criteria:

  • Serious hepatic, respiratory, hematologic, cardiovascular or renal condition
  • Neurologic pain other than TN, with the exception of occasional migranous/ tension-type headaches. (<4 headaches per month)
  • Psychiatric or medical condition that might compromise participation in study, as determined by the investigator
  • Use of opioid analgesic as treatment of neuralgia (>2 days per week)
  • Administration of any investigational drug within 30 days prior to screening
  • Concurrent use of sodium valproate
  • Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drug(s)
  • Pregnant or breastfeeding women
  • History of substance abuse/ alcoholism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203229

Locations
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
GlaxoSmithKline
Investigators
Principal Investigator: Marlind Alan Stiles, D.M.D. Thomas Jefferson University, Jefferson Headache Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00203229     History of Changes
Other Study ID Numbers: MAS/LAM101, H92001
Study First Received: September 13, 2005
Last Updated: January 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Double-Blind
Placebo-Controlled

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trigeminal Nerve Diseases
Cranial Nerve Diseases
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014