Acute MigraineNCT01276977
Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine
A study testing Zolmitriptan 5 mg Nasal Spray and Eletriptan 40 mg tablet in people with Acute Migraine and Migraine Headache, run by California Medical Clinic for Headache at 1 site in United States.
Trial summary
The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine. To develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Acute Migraine, Migraine Headache, Headache Disorders
- What is being tested?
- Zolmitriptan 5 mg Nasal Spray and Eletriptan 40 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2010
- Phase
- Interventional
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 15 to 70 years old
- Migraine attacks according to the criteria proposed by the IHS
- 3-12 Migraine attacks per month
- adequate contraception
- Willing and able to give written informed consent
- Willing and able to complete the entire course of the study \& comply with instructions
- Stable dose of preventive medication for at least 4 weeks
Who cannot join
- Disorders listen in groups 5-11 of the IHS Classification
- Subject is pregnant or lactating.
- Significant medical or psychiatric disease
- Subject has a history of symptoms suggestive of ischemic heart disease (angina, myocardial infarction, documented silent ischemia) or other vascular disease, including Prinzmetal angina, claudication, Wolff-Parkinson-White syndrome, or other cardiac accessory conduction pathway arrhythmia
- Subject has uncontrolled hypertension.
- Subject has history of basilar, ophthalmoplegic, or hemiplegic migraine or serious neurologic condition associated with headache
Show all 12Show fewer
- Subject has used monoamine oxidase A inhibitors (MAOI-As) within 2 weeks of randomization
- Subject has had serious adverse event while using another 5-HT agonist, or previous serious adverse event while using zolmitriptan or hypersensitivity to zolmitriptan or eletriptan
- Using CYP3A4 inhibitors listed by the FDA as contraindicated with eletriptan
- Moderate/severe hepatic/renal impairment
- Subject currently using cimetidine
- Concomitant medication treatment with a triptan, ergotamine or methysergide.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Medical Clinic for Headache
Santa Monica, California, 90404
About this study
Official title: Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine
The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine.
To develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at early time points.
To analyze the patterns of self-reported tolerability of migraine sufferers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
Read the detailed description
An open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal spray with eletriptan 40 mg tablet at early time points. Satisfaction endpoints include global assessment of preference, overall satisfaction and effectiveness as well as tolerability of both medications.
- Conditions
- Acute Migraine, Migraine Headache, Headache Disorders
- Being tested
- Zolmitriptan 5 mg Nasal Spray, Eletriptan 40 mg tablet
- Keywords
- Migraine, Acute Migraine, Headache
- Medical subject headings
- Migraine Disorders, Headache Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolmitriptan 5 mg Nasal SprayDrug
Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.
Eletriptan 40 mg tabletDrug
Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Zolmitriptan 5 mg nasal spray | Experimental | Not described Receives: Drug: Zolmitriptan 5 mg Nasal Spray; Drug: Eletriptan 40 mg tablet |
| Eletriptan 40 mg Tablet | Active comparator | Not described Receives: Drug: Zolmitriptan 5 mg Nasal Spray; Drug: Eletriptan 40 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of migraine headache pain from mild, moderate or severe to pain free.
Measured: 30 minutes post-dose
Secondary outcomes (1)
Reduction of migraine headache pain from mild, moderate or severe to pain free.
Measured: 15 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Medical Clinic for Headache
- Sponsor type
- University, hospital or other
- Investigators
- David B Kudrow, MD, Principal investigator, California Medical Clinic for Headache
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276977
- Sponsor's protocol ID
- IRUSZOLM0028
- Status last verified
- Jan 2011
- First submitted
- 11 Jan 2011
- Last updated
- 14 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT01276977
- Acronym / sponsor ID
- IRUSZOLM0028
- Conditions
- Acute Migraine, Migraine Headache, Headache Disorders
- Keywords
- Migraine, Acute Migraine, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- California Medical Clinic for HeadacheUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Jan 2011 (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 Compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine.
To develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at early time points.
To analyze the patterns of self-reported tolerability of migraine sufferers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
Detailed description
An open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal spray with eletriptan 40 mg tablet at early time points. Satisfaction endpoints include global assessment of preference, overall satisfaction and effectiveness as well as tolerability of both medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zolmitriptan 5 mg nasal spray | Experimental | Drug: Zolmitriptan 5 mg Nasal Spray, Drug: Eletriptan 40 mg tablet |
| Eletriptan 40 mg Tablet | Active comparator | Drug: Zolmitriptan 5 mg Nasal Spray, Drug: Eletriptan 40 mg tablet |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 15 to 70 years old
- Migraine attacks according to the criteria proposed by the IHS
- 3-12 Migraine attacks per month
- adequate contraception
- Willing and able to give written informed consent
Key exclusion criteria (12 listed)
- Disorders listen in groups 5-11 of the IHS Classification
- Subject is pregnant or lactating.
- Significant medical or psychiatric disease
- Subject has a history of symptoms suggestive of ischemic heart disease (angina, myocardial infarction, documented silent ischemia) or other vascular disease, including Prinzmetal angina, claudication, Wolff-Parkinson-White syndrome, or other cardiac accessory conduction pathway arrhythmia
- Subject has uncontrolled hypertension.
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 |
|---|---|---|
| Zolmitriptan 5 mg Nasal SprayPatients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan. | Drug | Eletriptan 40 mg Tablet, Zolmitriptan 5 mg nasal spray |
| Eletriptan 40 mg tabletPatients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray | Drug | Eletriptan 40 mg Tablet, Zolmitriptan 5 mg nasal spray |
Primary outcome
Reduction of migraine headache pain from mild, moderate or severe to pain free.
Time frame: 30 minutes post-dose
1 secondary outcome
Reduction of migraine headache pain from mild, moderate or severe to pain free.
Time frame: 15 minutes post-dose
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 Jan 2011.
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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.
David B Kudrow, MD principal investigator
California Medical Clinic for Headache
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zolmitriptan 5 mg Nasal Spray and Eletriptan 40 mg tablet in people with Acute Migraine and Migraine Headache, run by California Medical Clinic for Headache 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 7 inclusion and 12 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 Jan 2011. 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.
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 migraine headache pain from mild, moderate or severe to pain free. (time frame: 30 minutes post-dose). 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 14 Jan 2011.