Conditions: Trigeminal Neuralgia
Keywords: Double-Blind Placebo-Controlled
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief summary:
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.

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.

Arms:
arm 1: 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 arm 2: 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

Interventions: intervention 1: lamotrigine intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: