Migraine HeadachePhase 2NCT00055484
A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache
A Phase 2 study testing zonisamide in people with Migraine Headache, run by Elan Pharmaceuticals at 13 sites in United States.
Trial summary
The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- zonisamide
- How many people
- 204 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2002to May 2003
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all the following criteria will be eligible to participate in the study:
- Are men or women, between the ages of 18 and 65, inclusive.
- Satisfy diagnostic criteria for migraine headache, consistent with criteria described in Headache Classification Criteria.
- Have at least 4 migraine attacks per 28 days [each attack separated by at least 48 hours] prior to the Screening Visit and experience at least 4 migraine attacks during the Screen/Baseline Phase.
- Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as an adequate barrier method, hormonal contraceptive, or surgical sterilization. All women of childbearing potential must have a negative pregnancy test before entering the study and during the study.
- Are able to swallow the capsules whole.
- Are willing and able to follow Investigator instructions and study procedures, complete the daily diary, and report adverse events.
Who cannot join
- Subjects meeting any of the following criteria will not be eligible to participate in this study:
- Have required more than 3 different rescue medications for control of a single attack anytime within 3 months prior to the Screening Visit.
- Have cluster headache or chronic tension type headache and are unable to distinguish between their different types of headache.
- Have basilar or hemiplegic migraine.
- Have used triptans more than 3 times per week within 3 months prior to the Screening Visit.
- Have received botulinum toxin injection(s) within 3 months prior to the Screening Visit.
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- Have taken any other prophylactic medications for migraine within 5 half-lives prior to the Baseline Visit.
- Are pregnant or lactating.
- Have a history or current diagnosis of psychiatric disorder likely to require pharmacological intervention (e.g., antidepressants, MAO inhibitors, antipsychotics, mood-stabilizers, anxiolytics) during the study.
- Have clinically unstable cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease.
- Have laboratory test results that, in the opinion of the Investigator, are clinically significant abnormalities.
- Require treatment with any medication (e.g., daily opioids, daily beta-blockers, daily non-steroidal anti-inflammatory drugs, carbonic anhydrase inhibitors, eletriptan) or herbal supplements (e.g., St. John's Wort, ginseng, ginkgo biloba, kava kava, melatonin, petadolex) that might interact adversely with, or obscure, the action of the study medication.
- Have received psychoactive medication (e.g., other anticonvulsant drugs, antidepressants, antipsychotics, anxiolytics, mood stabilizers) within 5 half-lives prior to the Baseline Visit.
- Have previously enrolled in this study or previously treated with zonisamide.
- Have previously failed an adequate trial of another antiepilepsy drug for the treatment of migraine.
- Have a history of allergy or hypersensitivity to zonisamide or other sulfonamides.
- Have a history of skin rash, without other diagnosis, associated with any medication or any medical condition.
- Have a history of nephrolithiasis.
- Have received an experimental drug or used an experimental device within 30 days of the Screening Visit.
- Have a history of drug or alcohol abuse within 12 months prior to the Screening Visit.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Michigan Head-Pain & Neurological Institute
Ann Arbor, Michigan, 48104
MetaClin Research
Austin, Texas, 19107
Mercy Health Research
Chesterfield, Missouri, 63017
Houston Headache Clinic
Houston, Texas, 77004
Medical Affiliated Research Center
Huntsville, Alabama, 35801
University of South Alabama Medical Ctr Department of Neurology
Mobile, Alabama, 36693
Radiant Research
Overland Park, Kansas, 66215
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Valley Neurological Headache Clinic
Phoenix, Arizona, 85020
Radiant Research
Salt Lake City, Utah, 84111
Headache Care Center
Springfield, Missouri, 65804
The New England Center for Headache
Stamford, Connecticut, 06902
Neurological Associates of Tulsa
Tulsa, Oklahoma, 74136
About this study
Official title: A Double-Blind, Randomized, Multicenter, Parallel Dose Study to Evaluate the Safety and Efficacy of Zonisamide 150 mg and 300 mg Per Day and Placebo in Subjects With Migraine Headache
The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache.
Read the detailed description
The pharmacologic treatment of migraine may be acute (abortive, symptomatic) or preventive (prophylactic). Preventive medication is usually given daily for months or years; however, treatment may also be given in an intermittent regimen. Most migraine prophylactic medications were designed to treat other disorders, and they can be divided into three groups:
- Serotonergic or monoaminergic agents such as methysergide, which have demonstrated high degrees of effectiveness;
- Non-serotonergic drugs such as beta-blockers, tricyclic antidepressants, valproate; and
- Drugs with lesser demonstrated effectiveness, such as selective serotonin reuptake inhibitors, calcium channel antagonists, and non-steroidal anti-inflammatory drugs.
The choice of treatment must be individualized, and is influenced by contraindications, potential side effects, the need to treat associated symptoms like tension-type headache and insomnia, and drug cost.
Anticonvulsants, such as valproate, have shown significant degrees of efficacy in migraine prophylaxis when used in low doses. Considering the differences in proposed mechanisms of action of these agents, it is likely that a novel anticonvulsant such as zonisamide may also be an effective prophylactic treatment for migraine.
- Conditions
- Migraine Headache
- Being tested
- zonisamide
- Keywords
- Migraine Headache, prophylaxis, AED, migraine prophylaxis
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zonisamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2003 (estimated)
- Study startMar 2002
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 204 participants
Sponsor and investigators
- Lead sponsor
- Elan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055484
- Sponsor's protocol ID
- AN46046-228
- Status last verified
- Dec 2015
- First submitted
- 3 Mar 2003
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Multicenter, Parallel Dose Study to Evaluate the Safety and Efficacy of Zonisamide 150 mg and 300 mg Per Day and Placebo in Subjects With Migraine Headache
- ClinicalTrials.gov ID
- NCT00055484
- Acronym / sponsor ID
- AN46046-228
- Conditions
- Migraine Headache
- Keywords
- Migraine Headache, prophylaxis, AED, migraine prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants
- Lead sponsor
- Elan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- May 2003 (actual)
- First posted
- 5 Mar 2003 (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 purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache.
Detailed description
The pharmacologic treatment of migraine may be acute (abortive, symptomatic) or preventive (prophylactic). Preventive medication is usually given daily for months or years; however, treatment may also be given in an intermittent regimen. Most migraine prophylactic medications were designed to treat other disorders, and they can be divided into three groups:
- Serotonergic or monoaminergic agents such as methysergide, which have demonstrated high degrees of effectiveness;
- Non-serotonergic drugs such as beta-blockers, tricyclic antidepressants, valproate; and
- Drugs with lesser demonstrated effectiveness, such as selective serotonin reuptake inhibitors, calcium channel antagonists, and non-steroidal anti-inflammatory drugs.
The choice of treatment must be individualized, and is influenced by contraindications, potential side effects, the need to treat associated symptoms like tension-type headache and insomnia, and drug cost.
Anticonvulsants, such as valproate, have shown significant degrees of efficacy in migraine prophylaxis when used in low doses. Considering the differences in proposed mechanisms of action of these agents, it is likely that a novel anticonvulsant such as zonisamide may also be an effective prophylactic treatment for migraine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who meet all the following criteria will be eligible to participate in the study:
- Are men or women, between the ages of 18 and 65, inclusive.
- Satisfy diagnostic criteria for migraine headache, consistent with criteria described in Headache Classification Criteria.
- Have at least 4 migraine attacks per 28 days [each attack separated by at least 48 hours] prior to the Screening Visit and experience at least 4 migraine attacks during the Screen/Baseline Phase.
- Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as an adequate barrier method, hormonal contraceptive, or surgical sterilization. All women of childbearing potential must have a negative pregnancy test before entering the study and during the study.
Key exclusion criteria (20 listed)
- Subjects meeting any of the following criteria will not be eligible to participate in this study:
- Have required more than 3 different rescue medications for control of a single attack anytime within 3 months prior to the Screening Visit.
- Have cluster headache or chronic tension type headache and are unable to distinguish between their different types of headache.
- Have basilar or hemiplegic migraine.
- Have used triptans more than 3 times per week within 3 months prior to the Screening Visit.
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 |
|---|---|---|
| zonisamide | Drug | – |
Primary outcome
Not reported in the source record.
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 14 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zonisamide in people with Migraine Headache, run by Elan Pharmaceuticals at 13 sites 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 7 inclusion and 20 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 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
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 14 Dec 2015.