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

Sponsors and Collaborators: Monarch Medical Research
Ortho-McNeil Pharmaceutical
Information provided by: Monarch Medical Research
ClinicalTrials.gov Identifier: NCT00158002

Purpose

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

Further Study Details: 
Primary Outcomes: -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 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

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.

Eligibility

Ages Eligible for Study:  6 Years   -   18 Years,  Genders Eligible for Study:  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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00158002

Erika Paradiso, RN      757-668-7732    eparadiso@monarchresearch.com

Virginia
      Monarch Medical Research - Child and Adolescent Neurology, Norfolk,  Virginia,  23510,  United States; Recruiting
Sharon K Cole, RN  757-668-9932    scole@monarchresearch.com 
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

Study chairs or principal investigators

Donald W Lewis, MD,  Principal Investigator,  Monarch Medical Research   

More Information

Study ID Numbers:  CAPSS 299
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

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