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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203229
First received: September 13, 2005
Last updated: May 2, 2014
Last verified: May 2014
  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
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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:

Primary Outcome Measures:
  • Average Number of Pain Attacks [ Time Frame: Day 150 Visit #7 ] [ Designated as safety issue: No ]
    The average number of attacks daily experienced between Visit #1 and Visit #2 (baseline diary) was compared to the average daily number of attacks recorded between Visit #5 and Visit #7 after the patient has titrated the drug to the maximum tolerated dose.


Enrollment: 20
Study Start Date: June 2003
Study Completion Date: July 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
Drug: Placebo
The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
Other Name: Placebo
Active Comparator: Lamotrigine
Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
Drug: lamotrigine
The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal). This drug is an anti-seizure medication.
Other Names:
  • lamotrigine
  • Lamictal
  • Lamictal XR

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.

  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 trigeminal neuralgia (TN) using IHS (International Headache Society) 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 trigeminal neuralgia (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., non-steroidal anti-inflammatory medications, 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 (trigeminal neuralgia), with the exception of occasional migrainous/ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Marlind A Stiles, D.M.D. Thomas Jefferson University, Jefferson Headache Center
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00203229     History of Changes
Other Study ID Numbers: MAS/LAM101, H92001
Study First Received: September 13, 2005
Results First Received: February 7, 2014
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Trigeminal Neuralgia
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trigeminal Nerve Diseases
Cranial Nerve Diseases
Lamotrigine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on August 26, 2014