A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
This study has been completed.
Sponsor:
Monarch Medical Research
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Monarch Medical Research
ClinicalTrials.gov Identifier:
NCT00158002
First received: September 7, 2005
Last updated: April 4, 2007
Last verified: April 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Basilar Migraine |
Drug: Topiramate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
| Official Title: | An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial hemiplegic migraine
Drug Information available for:
Topiramate
U.S. FDA Resources
Further study details as provided by Monarch Medical Research:
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
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | August 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 to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158002
Locations
| United States, Virginia | |
| Monarch Medical Research - Child and Adolescent Neurology | |
| Norfolk, Virginia, United States, 23510 | |
Sponsors and Collaborators
Monarch Medical Research
Ortho-McNeil Neurologics, Inc.
Investigators
| Principal Investigator: | Donald W Lewis, MD | Monarch Medical Research |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00158002 History of Changes |
| Other Study ID Numbers: | CAPSS 299 |
| Study First Received: | September 7, 2005 |
| Last Updated: | April 4, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Monarch Medical Research:
|
Basilar/Hemiplegic Migraine Prophylaxis |
Additional relevant MeSH terms:
|
Migraine Disorders Migraine with Aura Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Topiramate |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |
ClinicalTrials.gov processed this record on May 19, 2013