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A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00158002
First Posted: September 12, 2005
Last Update Posted: April 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Monarch Medical Research
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00158002     History of Changes
Other Study ID Numbers: CAPSS 299
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: April 5, 2007
Last Verified: April 2007

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
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents