Status:
COMPLETED
A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
Lead Sponsor:
Monarch Medical Research
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Basilar Migraine
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00158002
Start Date
February 1 2004
End Date
August 1 2006
Last Update
April 5 2007
Active Locations (1)
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1
Monarch Medical Research - Child and Adolescent Neurology
Norfolk, Virginia, United States, 23510