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

Primary Purpose

Basilar Migraine

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topiramate
Sponsored by
Monarch Medical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Basilar Migraine focused on measuring Basilar/Hemiplegic Migraine, Prophylaxis

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Monarch Medical Research - Child and Adolescent Neurology

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
September 7, 2005
Last Updated
April 4, 2007
Sponsor
Monarch Medical Research
Collaborators
Ortho-McNeil Neurologics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00158002
Brief Title
A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
Official Title
An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Monarch Medical Research
Collaborators
Ortho-McNeil Neurologics, Inc.

4. Oversight

5. Study Description

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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basilar Migraine
Keywords
Basilar/Hemiplegic Migraine, Prophylaxis

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Topiramate
Primary Outcome Measure Information:
Title
Reduction of average monthly migraine days
Title
Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms
Title
Reduction in migraine pain severity and duration
Title
Migraine episode and headache episode frequency
Title
Total headache days
Title
Proportion of responders (i.e., the proportion of subjects who experience a 50% reduction in migraine-days and migraine episodes)
Secondary Outcome Measure Information:
Title
Cumulative frequency of migraine days and migraine episodes
Title
Use of acute/abortive medications
Title
Migraine episode and headache episode frequency
Title
Total headache days
Title
Migraine-associated symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald W Lewis, MD
Organizational Affiliation
Monarch Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monarch Medical Research - Child and Adolescent Neurology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States

12. IPD Sharing Statement

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

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