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Sponsors and Collaborators: |
Thomas Jefferson University GlaxoSmithKline |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00203229 |
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 |
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Trigeminal Neuralgia |
Drug: Lamotrigine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
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) |
Estimated Enrollment: | 38 |
Study Start Date: | June 2003 |
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.
Ages Eligible for Study: | 15 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Jefferson Headache Center | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Marlind Alan Stiles, D.M.D. | Thomas Jefferson University, Jefferson Headache Center |
Study ID Numbers: | MAS/LAM101, H92001 |
Study First Received: | September 13, 2005 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00203229 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Double-Blind Placebo-Controlled |
Neuralgia Calcium Channel Blockers Pain Tic Disorders Cardiovascular Agents Tics Signs and Symptoms |
Calcium, Dietary Neuromuscular Diseases Peripheral Nervous System Diseases Lamotrigine Neurologic Manifestations Anticonvulsants Trigeminal Neuralgia |
Molecular Mechanisms of Pharmacological Action Neuralgia Nervous System Diseases Calcium Channel Blockers Pain Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators Signs and Symptoms Neuromuscular Diseases |
Therapeutic Uses Peripheral Nervous System Diseases Lamotrigine Neurologic Manifestations Trigeminal Nerve Diseases Cranial Nerve Diseases Central Nervous System Agents Anticonvulsants Trigeminal Neuralgia |