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Adequate Therapy of Topiramate in Migraine

2014-07-23 21:10:54 | BioPortfolio

Summary

The objective of this study is to investigate the adequacy of topiramate therapy in prevention of migraine and to compare standard titration therapy to slow titration therapy and slow titration therapy boosted by the concurrent use of propranolol.

Description

The objective of this prospective, single-blind, randomized and comparative multi-center study is to investigate the adequacy of topiramate therapy in prevention of migraine and to compare standard titration therapy to slow titration therapy and slow titration therapy boosted by the concurrent use of propranolol. The secondary objectives of this clinical study are to examine the change in patient quality of life as measured by the migraine disability assessment (MIDAS) questionnaire and to assess the incidence of adverse events, drug compliance and drug safety. Standard therapy of topiramate 50mg/d will be used as an initial target dose and increased by 25 mg/d in 1-week to a maximum maintenance dose of 100mg/d. Slow therapy of topiramate 50mg/d will be used as an initial target dose and increased by 25 mg/d in 2-weeks to a maximum maintenance dose of 100mg/d. Slow titration therapy boosted by the concurrent use of propranolol ( propranolol 80mg/d as an initial booster for 6 weeks and topiramate 50mg/d as an initial target dose, increased by 25 mg/d in 2-weeks to a maximum maintenance dose of 100mg/d) will also be evaluated. Standard therapy: topiramate 50mg/d as an initial target dose, increased by 25 mg/d in 1-week to a maximum maintenance dose of 100mg/d. Slow therapy: topiramate 50mg/d as an initial target dose, increased by 25 mg/d in 2-weeks to a maximum maintenance dose of 100mg/d. Slow titration therapy and propranolol group: propranolol 80mg/d as an initial booster for 6 weeks and topiramate 50mg/d as an initial target dose, increased by 25 mg/d in 2-weeks to a maximum maintenance dose of 100mg/d.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Conditions

Migraine Disorders

Intervention

Topiramate standard, Topiramate and propranolol, Topiramate slow titration

Status

Completed

Source

Janssen Korea, Ltd., Korea

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:54-0400

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Medical and Biotech [MESH] Definitions

A widely used non-cardioselective beta-adrenergic antagonist. Propranolol has been used for MYOCARDIAL INFARCTION; ARRHYTHMIA; ANGINA PECTORIS; HYPERTENSION; HYPERTHYROIDISM; MIGRAINE; PHEOCHROMOCYTOMA; and ANXIETY but adverse effects instigate replacement by newer drugs.

A beta-adrenergic antagonist similar in action to PROPRANOLOL. The levo-isomer is the more active. Timolol has been proposed as an antihypertensive, antiarrhythmic, antiangina, and antiglaucoma agent. It is also used in the treatment of MIGRAINE DISORDERS and tremor.

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A cardioselective beta-adrenergic blocker possessing properties and potency similar to PROPRANOLOL, but without a negative inotropic effect.

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