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

Condition(s) targeted: Basilar Migraine

Intervention: Topiramate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Monarch Medical Research

Official(s) and/or principal investigator(s):
Donald W Lewis, MD, Principal Investigator, Affiliation: Monarch Medical Research

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.

Official title: An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

Study design: Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Reduction of average monthly migraine days

Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms

Reduction in migraine pain severity and duration

Migraine episode and headache episode frequency

Total headache days

Proportion of responders (i.e., the proportion of subjects who experience a 50% reduction in migraine-days and migraine episodes)

Secondary outcome:

Cumulative frequency of migraine days and migraine episodes

Use of acute/abortive medications

Migraine episode and headache episode frequency

Total headache days

Migraine-associated symptoms

Detailed 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.

Minimum age: 6 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must have either completed the Double-Blind Phase of CAPSS-271 or discontinued the

Double-Blind Phase of CAPSS-271 due to lack of efficacy after a minimum of 2 weeks of maintenance treatment.

- Must continue to meet the specific inclusion criteria outlined in CAPSS-271.

- Female subjects must be premenarchal, surgically sterile (hysterectomy, tubal ligation

or otherwise incapable of pregnancy); or practicing an effective method of birth control (e. g., intrauterine device, double-barrier method, male partner sterilization) at study entry and throughout the study; or hormonal contraceptives for at least a 3-month period prior to the start of the study and throughout the study, or be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence. In addition, female subjects of childbearing potential must have a negative urine pregnancy test at Open-Label Visit 1 (Day 1).

- Must be able to read and comprehend written instructions and be willing to complete

all headache records and questionnaires as required by the protocol.

- After full explanation of the study, subjects, or their parent/legally authorized

representative(s), must demonstrate their willingness to participate by signing an informed consent form. If applicable, pediatric subjects capable of giving assent must sign the assent form.

Exclusion Criteria:

- Subjects who have developed a more painful condition than their headache pain.

- Subjects taking any of the prohibited concomitant medications (See Concomitant

Medications section).

- Subjects who are pregnant.

- Subjects with liver function tests ³ 2 times the upper limit of the normal range.

- In the investigator’s opinion, subjects with poor compliance during the CAPSS-271

study

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

Starting date: February 2004
Ending date: August 2006
Last updated: April 4, 2007