NCT00131443

Brief Summary

The objective of this study is to assess the effectiveness and safety 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2006

First QC Date

August 15, 2005

Last Update Submit

November 9, 2012

Conditions

Basilar Migraine

Keywords

Basilar/Hemiplegic MigraineProphylaxis

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy outcome will be the reduction in average monthly migraine-days over the entire double-blind phase relative to the prospective baseline period

Secondary Outcomes (8)

  • Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms

  • Reduction in migraine pain severity and duration

  • Reduction in migraine episode and headache episode frequency

  • Reduction in total headache days

  • Proportion of responders (i.e., the proportion of subjects who experience a ≥ 50% reduction in migraine-days and migraine episodes)

  • +3 more secondary outcomes

Interventions

TopiramateDRUG

Eligibility Criteria

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

You may qualify if:

  • Must meet International Headache Society (IHS) classification of pediatric migraine with aura: familial hemiplegic migraine (International Classification of Headache Disorders \[ICHD\] 1.2.4), sporadic hemiplegic migraine (ICHD 1.2.5) or basilar-type migraine (ICHD 1.2.6).
  • Average of 4 migraine-days/month during the 3 months prior to screening.
  • migraine-days during prospective baseline period.
  • At least one of the subject's migraines during the previous 3 months must have been accompanied by their characteristic basilar-type or hemiplegic neurologic symptoms of moderate to severe degree.
  • years of age.
  • Weigh more than 25 kg.
  • If female, subjects must:
  • be premenarchal or otherwise incapable of pregnancy, or
  • have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility, or
  • be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence.
  • If (b) or (c), the subject must have a negative urine pregnancy test within one week of study entry.
  • Able to take oral medication in tablet form
  • Willing and able to:
  • read and comprehend written instructions,
  • complete the assessment forms,
  • +1 more criteria

You may not qualify if:

  • Previously failed topiramate therapy for migraine prophylaxis or those who discontinued topiramate due to adverse events.
  • Have taken topiramate within 14 days prior to the start of the prospective baseline period.
  • Have 15 or more headache-days during the prospective baseline period.
  • Have cluster headaches or chronic migraine.
  • Have migraine aura without headache exclusively.
  • Currently have a more painful condition than their migraine pain.
  • Have taken any medications for migraine prophylaxis, within 2 weeks of the start of the prospective baseline period.
  • Progressive neurological disorders or a structural disorder of the brain
  • Overuse analgesic or migraine-specific agents for abortive treatment of migraine:
  • \>10 treatment days/month of ergot-containing medication, triptans, or opioids;
  • \>15 treatment days/month with simple analgesics (including NSAIDs)
  • Require any injections of corticosteroids or local anesthetics within 60 days of visit 1 or botulinum toxin within 120 days prior to Visit 1.
  • Have previously failed more than 2 adequate trials of an established prophylactic anti-migraine regimen.
  • Subjects starting non-pharmacologic prophylactic approaches within 1 month prior to Visit 1. Non-pharmacologic prophylactic approaches started at least 1 month prior to Visit 1 should be continued throughout the study.
  • Have taken carbonic anhydrase inhibitors or triamterene within 1 month prior to Visit 1.
  • +10 more criteria

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
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 18, 2005

Study Start

February 1, 2004

Study Completion

August 1, 2006

Last Updated

November 12, 2012

Record last verified: 2006-11

Locations

US(1)