A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine - Full Text View

Sponsor:	Monarch Medical Research
Collaborator:	Ortho-McNeil Neurologics, Inc.
Information provided by:	Monarch Medical Research
ClinicalTrials.gov Identifier:	NCT00158002

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 II

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

MedlinePlus related topics: Headache 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

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

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 February 12, 2012