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A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

2014-08-27 03:51:21 | BioPortfolio

Summary

The objective of this study is to assess the long-term safety and effectiveness of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.

Description

This is a single-center, open-label study consisting of 3 phases: Blinded Transition Phase, Open-Label Maintenance Phase, and Taper/Exit Phase. Subjects who have either succesfully completed the CAPSS-271 protocol or who discontinued the CAPSS-271 study due to lack of effectiveness after completing at least 2 weeks of maintenance treatment will be eligible to enroll.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Conditions

Basilar Migraine

Intervention

Topiramate

Location

Monarch Medical Research - Child and Adolescent Neurology
Norfolk
Virginia
United States
23510

Status

Completed

Source

Monarch Medical Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:51:21-0400

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Medical and Biotech [MESH] Definitions

A basement membrane in the cochlea that supports the hair cells of the ORGAN OF CORTI, consisting keratin-like fibrils. It stretches from the SPIRAL LAMINA to the basilar crest. The movement of fluid in the cochlea, induced by sound, causes displacement of the basilar membrane and subsequent stimulation of the attached hair cells which transform the mechanical signal into neural activity.

A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

A subtype of migraine disorder, characterized by recurrent attacks of reversible neurological symptoms (aura) that precede or accompany the headache. Aura may include a combination of sensory disturbances, such as blurred VISION; HALLUCINATIONS; VERTIGO; NUMBNESS; and difficulty in concentrating and speaking. Aura is usually followed by features of the COMMON MIGRAINE, such as PHOTOPHOBIA; PHONOPHOBIA; and NAUSEA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

An acquired or spontaneous abnormality in which there is communication between CAVERNOUS SINUS, a venous structure, and the CAROTID ARTERIES. It is often associated with HEAD TRAUMA, specifically basilar skull fractures (SKULL FRACTURE, BASILAR). Clinical signs often include VISION DISORDERS and INTRACRANIAL HYPERTENSION.

The inferior region of the skull consisting of an internal (cerebral), and an external (basilar) surface.

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