Basilar MigrainePhase 2/3NCT00131443
Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
A Phase 2/3 study testing Topiramate in people with Basilar Migraine, run by Monarch Medical Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Basilar Migraine
- What is being tested?
- Topiramate
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Aug 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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,
- return for regular visits, and d) adhere to medication regimens.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Monarch Medical Research - Child and Adolescent Neurology
Norfolk, Virginia, 23510
About this study
Official title: A Double-Blind Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
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.
Read the 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.
- Conditions
- Basilar Migraine
- Being tested
- Topiramate
- Keywords
- Basilar/Hemiplegic Migraine, Prophylaxis
- Medical subject headings
- Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Cumulative reduction in frequency of migraine days and migraine episodes
Reduction in the use of acute/abortive medications
Reduction in migraine-associated symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startFeb 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basilar MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Monarch Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- Donald W Lewis, MD, Principal investigator, Monarch Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131443
- Sponsor's protocol ID
- CAPSS 271
- Status last verified
- Nov 2006
- First submitted
- 15 Aug 2005
- Last updated
- 12 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
- ClinicalTrials.gov ID
- NCT00131443
- Acronym / sponsor ID
- CAPSS 271
- Conditions
- Basilar Migraine
- Keywords
- Basilar/Hemiplegic Migraine, Prophylaxis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Monarch Medical ResearchUniversity, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Feb 2004
- Study completion
- Aug 2006
- First posted
- 18 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate | Drug | – |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald W Lewis, MD principal investigator
Monarch Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Topiramate in people with Basilar Migraine, run by Monarch Medical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.