Sumatriptan-naproxen for acute treatment of migraine: a randomized trial.

Context: Multiple pathogenic mechanisms may be involved in generating the migraine symptom complex, and multimechanism-targeted therapy may confer advantages over monotherapy.

Objective: To evaluate the efficacy and safety of a fixed-dose tablet containing sumatriptan succinate and naproxen sodium relative to efficacy and safety of each monotherapy and placebo for the acute treatment of migraine.

Design, Setting, And Participants: Two replicate, randomized, double-blind, single-attack, parallel-group studies conducted among 1461 (study 1) and 1495 (study 2) patients at 118 US clinical centers who were diagnosed as having migraine and received study treatment for a moderate or severe migraine attack.

Prevalence of migraine and response to sumatriptan in patients self-reporting tension/stress headache.

Objective: This study was conducted to evaluate the prevalence of migraine and its responsiveness to migraine-specific therapy in patients with self-reported tension-type headache.

Methods: Patients were adults (n = 423) consulting one of 54 North American study sites including primary care clinics, neurology clinics, and headache clinics. The study comprised an initial diagnosis phase to determine the headache diagnosis of patients entering the study with self-reported tension/stress headache, including that previously diagnosed by a health care provider.

Two replicate randomized, double-blind, placebo-controlled trials of the time to onset of pain relief in the acute treatment of migraine with a fast-disintegrating/rapid-release formulation of sumatriptan tablets.

Background: The gastric stasis that commonly accompanies migraine headache may impair absorption of conventional oral tablets in the stomach. A fast-disintegrating/rapid-release formulation of sumatriptan has been developed to enhance tablet disintegration and drug dispersion and potentially improve absorption.

Objective: Two studies were conducted comparing the time to onset of relief from moderate or severe migraine pain with the fast-disintegrating/rapid-release formulation of sumatriptan tablets 50 and 100 mg and placebo.

Lamotrigine monotherapy improves health-related quality of life in epilepsy: a double-blind comparison with valproate.

The effects of monotherapy with lamotrigine on health-related quality of life were compared with those of valproate monotherapy in a randomized, double-blind trial designed to evaluate treatment-emergent weight changes in patients with epilepsy. At the end of 8 months of treatment, significantly more patients using lamotrigine compared with valproate experienced quality-of-life improvements on the Health Perceptions (42% vs 15%), Energy/Fatigue (47% vs 28%), and Social Isolation (35% vs 16%) subscales of the Quality of Life in Epilepsy-89 (QOLIE-89) questionnaire (P<0.05).

Lamotrigine Monotherapy Improves Depressive Symptoms in Epilepsy: A Double-Blind Comparison with Valproate.

Depressive symptoms are highly prevalent in patients with epilepsy. The antiepileptic drug lamotrigine has been shown to be an effective treatment for the depressive phase of bipolar disorder and to enhance mood and well-being in epilepsy patients. The effects of lamotrigine monotherapy on depressive symptoms in epilepsy have not been evaluated to date in a controlled clinical trial.