MigrainePhase 4RinotamaNCT01057160
Rizatriptan 10 MG RPD in the Treatment of Acute Migraine
A Phase 4 study testing Rizatriptan in people with Migraine, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
This is a multicentre, open label, prospective, randomized, two-attack study with active comparator in patients reporting inadequate response to analgesics and/or triptans to examine the efficacy of Rizatriptan 10 mg RPD in this group of patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Rizatriptan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Jun 2010
- Phase
- Phase 4
- 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
- Patient's signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form].
- Have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
- At screening at least two migraine attacks per month and no more than ten during the last three months prior to inclusion.
- At screening a stable dose of prophylactic medication (including no prophylactic treatment) for at least two months and no change of prophylactic medication during active trial period.
Who cannot join
- Contraindication to triptans or Rizatriptan according to medical information sheet.
- Patient has a history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease. Patient has uncontrolled hypertension. Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to Rizatriptan or any of its inactive ingredients.
- History of treatment failure for at least one triptan for the treatment of acute migraine attacks.
- Any other headache, except tension type headache on 5 or less days a month within three months prior to screening.
- A history of drug induced headache, medication overuse headache or any other addiction.
- Any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial.
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- Females of childbearing potential not using reliable means of birth control, pregnant or lactating females or expected/ planned pregnancy.
- Participation (planned or current) in any investigational drug or device trial within the previous 30 days prior to screening visit.
- Inability to understand the trial procedures, and thus inability to give informed consent.
- History of allergy to sulfa drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Efficacy and Safety of Rizatriptan 10 mg RPD in the Treatment of Acute Migraine in Patients With Non Satisfactory Response to Previous Pharmacologic Treatment
This is a multicentre, open label, prospective, randomized, two-attack study with active comparator in patients reporting inadequate response to analgesics and/or triptans to examine the efficacy of Rizatriptan 10 mg RPD in this group of patients.
- Conditions
- Migraine
- Being tested
- Rizatriptan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RizatriptanDrug
use of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic
| Study group | Role | What they receive |
|---|---|---|
| intake of rizatriptan 10 mg | Experimental | Not described Receives: Drug: Rizatriptan |
| previous used analgesic | Active comparator | Not described Receives: Drug: Rizatriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with headache response on a one to four scale after 2 hours.
Measured: 2 hours
Secondary outcomes (1)
Percentage of patients being headache free two hours after intake of study medication. Time of dosing to onset of headache relieve. Relief of concomitant symptoms. Rate of sustained pain free Percentage of patients needing rescue medication
Measured: (time points 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours after drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startMay 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Hans-Christoph Diener, Universität Duisburg-Essen
- Investigators
- Hans-Christoph Diener, Prof., Principal investigator, Department of Neurology, University Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057160
- Sponsor's protocol ID
- MK 462
- Acronym
- Rinotama
- Status last verified
- Jan 2013
- First submitted
- 26 Jan 2010
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy and Safety of Rizatriptan 10 mg RPD in the Treatment of Acute Migraine in Patients With Non Satisfactory Response to Previous Pharmacologic Treatment
- ClinicalTrials.gov ID
- NCT01057160
- Acronym / sponsor ID
- Rinotama / MK 462
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Jan 2010 (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.
This is a multicentre, open label, prospective, randomized, two-attack study with active comparator in patients reporting inadequate response to analgesics and/or triptans to examine the efficacy of Rizatriptan 10 mg RPD in this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intake of rizatriptan 10 mg | Experimental | Drug: Rizatriptan |
| previous used analgesic | Active comparator | Drug: Rizatriptan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient's signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form].
- Have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
- At screening at least two migraine attacks per month and no more than ten during the last three months prior to inclusion.
- At screening a stable dose of prophylactic medication (including no prophylactic treatment) for at least two months and no change of prophylactic medication during active trial period.
Key exclusion criteria (10 listed)
- Contraindication to triptans or Rizatriptan according to medical information sheet.
- Patient has a history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease. Patient has uncontrolled hypertension. Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to Rizatriptan or any of its inactive ingredients.
- History of treatment failure for at least one triptan for the treatment of acute migraine attacks.
- Any other headache, except tension type headache on 5 or less days a month within three months prior to screening.
- A history of drug induced headache, medication overuse headache or any other addiction.
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 |
|---|---|---|
| Rizatriptanuse of rizatriptan 10 mg for one migraine attack, in comparison to previously used analgetic | Drug | intake of rizatriptan 10 mg, previous used analgesic |
Primary outcome
Percentage of patients with headache response on a one to four scale after 2 hours.
Time frame: 2 hours
1 secondary outcome
Percentage of patients being headache free two hours after intake of study medication. Time of dosing to onset of headache relieve. Relief of concomitant symptoms. Rate of sustained pain free Percentage of patients needing rescue medication
Time frame: (time points 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours after drug intake
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 28 Jan 2013.
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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.
Hans-Christoph Diener, Prof. principal investigator
Department of Neurology, University Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rizatriptan in people with Migraine, run by Universität Duisburg-Essen at 1 site in Germany.
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 4 inclusion and 10 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 28 Jan 2013. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage of patients with headache response on a one to four scale after 2 hours. (time frame: 2 hours). 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 28 Jan 2013.