An Open-Label Study of Topiramate in Pediatric Subjects with Basilar/Hemiplegic Migraine - Article Headache and Migraine; Migraine headache; Migraine Headaches
Clinical Trial: An Open-Label Study of Topiramate in Pediatric Subjects with Basilar/Hemiplegic Migraine
This study is currently recruiting patients.
Verified by Monarch Medical Research September 2005
|Basilar Migraine || Drug: Topiramate ||Phase II |
MedlinePlus related topics: Migraine
Study Type: Interventional
Study Design: Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Secondary Outcomes: -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
Expected Total Enrollment: 40
Study start: February 2004; Expected completion: December 2006
Last follow-up: August 2006; Data entry closure: October 2006
- 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.
- 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
Location and Contact Information
Monarch Medical Research - Child and Adolescent Neurology, Norfolk, Virginia, 23510, United States; Recruiting
L. Matthew Frank, MD, Sub-Investigator
Donald W. Lewis, MD, Principal Investigator
Ralph S Northam, MD, Sub-Investigator
Svinder S Toor, MD, Sub-Investigator
Larry E White, MD, Sub-Investigator
Donald W Lewis, MD, Principal Investigator, Monarch Medical Research
Last Updated: September 10, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00158002
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13