NCT00158002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

April 5, 2007

Status Verified

April 1, 2007

First QC Date

September 7, 2005

Last Update Submit

April 4, 2007

Conditions

Basilar Migraine

Keywords

Basilar/Hemiplegic MigraineProphylaxis

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • 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

Interventions

TopiramateDRUG

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monarch Medical Research - Child and Adolescent Neurology

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Migraine with Aura

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Donald W Lewis, MD

    Monarch Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

February 1, 2004

Study Completion

August 1, 2006

Last Updated

April 5, 2007

Record last verified: 2007-04

Locations

US(1)