Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Monarch Medical Research
ClinicalTrials.gov Identifier:
NCT00131443
First received: August 15, 2005
Last updated: November 9, 2012
Last verified: November 2006
  Purpose

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.


Condition Intervention Phase
Basilar Migraine
Drug: Topiramate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Double-Blind Dose Comparison 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:
  • 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 Outcome Measures:
  • 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)
  • Cumulative reduction in frequency of migraine days and migraine episodes
  • Reduction in the use of acute/abortive medications
  • Reduction in migraine-associated symptoms

Estimated Enrollment: 40
Study Start Date: February 2004
Estimated Study Completion Date: August 2006
Detailed Description:

The objective of this study is to assess the efficacy and safety of topiramate in the prophylaxis of basilar migraine and hemiplegic migraine in children and adolescents, by comparing two doses, 25 and 100 mg/day.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 4 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.
  • 6-18 years of age.
  • Weigh more than 25 kg.
  • If female, subjects must:

    1. be premenarchal or otherwise incapable of pregnancy, or
    2. 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
    3. 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:

    1. read and comprehend written instructions,
    2. complete the assessment forms,
    3. return for regular visits, and d) adhere to medication regimens.

Exclusion Criteria:

  • 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.
  • History of nephrolithiasis.
  • Require continuing treatment with anticonvulsant therapy for a non-migraine condition.
  • Significant major psychiatric disorder (e.g., major depression) or subjects receiving anti-psychotic medication.
  • History of attempted suicide or suicidal tendencies.
  • History of substance abuse.
  • Pregnant or lactating females.
  • Clinically unstable neurological, cardiovascular, gastrointestinal, musculoskeletal, pulmonary or other disease.
  • Active liver disease.
  • AST and/or ALT levels greater than 2 times the upper limit of normal range.
  • Received an investigational drug or used an investigational device within 30 days of study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131443

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: NCT00131443     History of Changes
Other Study ID Numbers: CAPSS 271
Study First Received: August 15, 2005
Last Updated: November 9, 2012
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 July 26, 2014