- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00158002
A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
April 4, 2007 updated by: Monarch Medical Research
An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
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.
Study Overview
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.
Study Type
Interventional
Enrollment
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Norfolk, Virginia, United States, 23510
- Monarch Medical Research - Child and Adolescent Neurology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms
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Reduction in migraine pain severity and duration
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Reduction of average monthly migraine days
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Migraine episode and headache episode frequency
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Total headache days
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Proportion of responders (i.e., the proportion of subjects who experience a 50% reduction in migraine-days and migraine episodes)
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Secondary Outcome Measures
Outcome Measure |
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Migraine episode and headache episode frequency
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Total headache days
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Cumulative frequency of migraine days and migraine episodes
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Use of acute/abortive medications
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Migraine-associated symptoms
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Donald W Lewis, MD, Monarch Medical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion
August 1, 2006
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 10, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
April 5, 2007
Last Update Submitted That Met QC Criteria
April 4, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAPSS 299
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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