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A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
This study has been completed.
Study NCT00158002   Information provided by Monarch Medical Research
First Received: September 7, 2005   Last Updated: April 4, 2007   History of Changes

September 7, 2005
April 4, 2007
February 2004
 
  • 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)
  • -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)
Complete list of historical versions of study NCT00158002 on ClinicalTrials.gov Archive Site
  • 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
  • -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
 
A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

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.

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.

Phase II
Interventional
Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Basilar Migraine
Drug: Topiramate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
August 2006
 

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
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158002
 
CAPSS 299
Monarch Medical Research
Ortho-McNeil Neurologics, Inc.
Principal Investigator: Donald W Lewis, MD Monarch Medical Research
Monarch Medical Research
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP