Basilar MigrainePhase 2NCT00158002
A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
A Phase 2 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 long-term safety and effectiveness 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
- 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 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.
Who cannot join
- 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
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: 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.
Read the detailed description
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.
- 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.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 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
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT00158002
- Sponsor's protocol ID
- CAPSS 299
- Status last verified
- Apr 2007
- First submitted
- 7 Sep 2005
- Last updated
- 5 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
- ClinicalTrials.gov ID
- NCT00158002
- Acronym / sponsor ID
- CAPSS 299
- Conditions
- Basilar Migraine
- Keywords
- Basilar/Hemiplegic Migraine, Prophylaxis
- Phase
- Phase 2
- 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
- 12 Sep 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 long-term safety and effectiveness of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.
Detailed description
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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
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)
5 secondary outcomes
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
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 5 Apr 2007.
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 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 5 inclusion and 5 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 5 Apr 2007. 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 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.
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?
Reduction of average monthly migraine days. The study lists 6 primary outcomes in all. 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 5 Apr 2007.