Clinical trial NCT00158002: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Basilar Migraine
Keywords: Basilar/Hemiplegic Migraine
Prophylaxis
Lead sponsor: Monarch Medical Research
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Neurologics, Inc.
First posted: 2005-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

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.

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

Primary outcomes:
measure: Reduction of average monthly migraine days
measure: Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms
measure: Reduction in migraine pain severity and duration
measure: Migraine episode and headache episode frequency
measure: Total headache days
measure: Proportion of responders (i.e., the proportion of subjects who experience a 50% reduction in migraine-days and migraine episodes)
Secondary outcomes:
measure: Cumulative frequency of migraine days and migraine episodes
measure: Use of acute/abortive medications
measure: Migraine episode and headache episode frequency
measure: Total headache days
measure: Migraine-associated symptoms
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Monarch Medical Research - Child and Adolescent Neurology
state: Virginia
Study officials:
affiliation: Monarch Medical Research
name: Donald W Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: