Basilar Migraine Clinical Trial
Official title:
An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
Verified date | April 2007 |
Source | Monarch Medical Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 18 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
Country | Name | City | State |
---|---|---|---|
United States | Monarch Medical Research - Child and Adolescent Neurology | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Monarch Medical Research | Ortho-McNeil Neurologics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of average monthly migraine days | |||
Primary | Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms | |||
Primary | Reduction in migraine pain severity and duration | |||
Primary | Migraine episode and headache episode frequency | |||
Primary | Total headache days | |||
Primary | Proportion of responders (i.e., the proportion of subjects who experience a 50% reduction in migraine-days and migraine episodes) | |||
Secondary | Cumulative frequency of migraine days and migraine episodes | |||
Secondary | Use of acute/abortive medications | |||
Secondary | Migraine episode and headache episode frequency | |||
Secondary | Total headache days | |||
Secondary | Migraine-associated symptoms |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00131443 -
Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
|
Phase 2/Phase 3 |