A Double-Blind Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

Monarch Medical Research1 site in 1 country40 target enrollmentFebruary 2004

ConditionsBasilar Migraine

DrugsTopiramate

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Basilar Migraine
Sponsor: Monarch Medical Research
Enrollment: 40
Locations: 1
Primary Endpoint: The primary efficacy outcome will be the reduction in average monthly migraine-days over the entire double-blind phase relative to the prospective baseline period
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

The objective of this study is to assess the efficacy and safety of topiramate in the prophylaxis of basilar migraine and hemiplegic migraine in children and adolescents, by comparing two doses, 25 and 100 mg/day.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

August 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Monarch Medical Research

Eligibility Criteria

Inclusion Criteria

•Must meet International Headache Society (IHS) classification of pediatric migraine with aura: familial hemiplegic migraine (International Classification of Headache Disorders \[ICHD\] 1.2.4), sporadic hemiplegic migraine (ICHD 1.2.5) or basilar-type migraine (ICHD 1.2.6).
•Average of 4 migraine-days/month during the 3 months prior to screening.
•4 migraine-days during prospective baseline period.
•At least one of the subject's migraines during the previous 3 months must have been accompanied by their characteristic basilar-type or hemiplegic neurologic symptoms of moderate to severe degree.
•6-18 years of age.
•Weigh more than 25 kg.
•If female, subjects must:
•be premenarchal or otherwise incapable of pregnancy, or
•have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility, or
•be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence.

Exclusion Criteria

•Previously failed topiramate therapy for migraine prophylaxis or those who discontinued topiramate due to adverse events.
•Have taken topiramate within 14 days prior to the start of the prospective baseline period.
•Have 15 or more headache-days during the prospective baseline period.
•Have cluster headaches or chronic migraine.
•Have migraine aura without headache exclusively.
•Currently have a more painful condition than their migraine pain.
•Have taken any medications for migraine prophylaxis, within 2 weeks of the start of the prospective baseline period.
•Progressive neurological disorders or a structural disorder of the brain
•Overuse analgesic or migraine-specific agents for abortive treatment of migraine:
•\>10 treatment days/month of ergot-containing medication, triptans, or opioids;

Outcomes

Primary Outcomes

The primary efficacy outcome will be the reduction in average monthly migraine-days over the entire double-blind phase relative to the prospective baseline period

Secondary Outcomes

Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms
Reduction in migraine pain severity and duration
Reduction in migraine episode and headache episode frequency
Reduction in total headache days
Proportion of responders (i.e., the proportion of subjects who experience a ≥ 50% reduction in migraine-days and migraine episodes)
Cumulative reduction in frequency of migraine days and migraine episodes
Reduction in the use of acute/abortive medications
Reduction in migraine-associated symptoms