Migraine DisordersNCT01376193
Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet
An observational study of Migraine Disorders, run by GlaxoSmithKline.
Trial summary
The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Naratriptan
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Oct 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese subjects with migraine headache
Who may be able to join
- Subjects with migraine headache
- Must use naratriptan tablets for the first time
Who cannot join
- Subjects with hypersensitivity to naratriptan
- Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
- Subjects with history of peripheral vascular disorder
- Subjects with history of cerebrovascular disorder or transient ischemic attacks
- Subjects with uncontrolled high-blood pressure
- Subjects with severe hepatic function disorder or renal function disorder
- Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
About this study
The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.
- Conditions
- Migraine Disorders
- Being tested
- Naratriptan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaratriptanDrug
Collection of safety data
| Study group | Role | What they receive |
|---|---|---|
| Subjects prescribed naratriptan tablets | Subjects with migraine headache prescribed naratriptan tablets during study period Receives: Drug: Naratriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of incidence of adverse events in subjects with migraine headache
Measured: 2 months
Secondary outcomes (3)
Occurrence of cardiovascular-related adverse events
Occurrence of cardiovascular-related adverse events is investigated throughout study period
Measured: 2 months
Occurrence of cerebrovascular disorder
Occurrence of cerebrovascular disorder is investigated throughout study period
Measured: 2 months
Occurrence of serotonin syndrome
Occurrence of serotonin syndrome is investigated throughout study period
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startApr 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376193
- Sponsor's protocol ID
- 112924
- Status last verified
- May 2013
- First submitted
- 9 Jun 2011
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Takao Takeshima, Atsuko Ishida, Terufumi Hara. Drug Use Investigation on Naratriptan Tablets (Amerge®) in Patients with Migraine. [Prog Med]. 2012;32(8):95-105.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet
- ClinicalTrials.gov ID
- NCT01376193
- Acronym / sponsor ID
- 112924
- Conditions
- Migraine Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Jun 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 study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects prescribed naratriptan tablets | – | Drug: NaratriptanSubjects with migraine headache prescribed naratriptan tablets during study period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese subjects with migraine headache
Key inclusion criteria (2 listed)
- Subjects with migraine headache
- Must use naratriptan tablets for the first time
Key exclusion criteria (7 listed)
- Subjects with hypersensitivity to naratriptan
- Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
- Subjects with history of peripheral vascular disorder
- Subjects with history of cerebrovascular disorder or transient ischemic attacks
- Subjects with uncontrolled high-blood pressure
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 |
|---|---|---|
| NaratriptanCollection of safety data | Drug | Subjects prescribed naratriptan tablets |
Primary outcome
The number of incidence of adverse events in subjects with migraine headache
Time frame: 2 months
3 secondary outcomes
Occurrence of cardiovascular-related adverse events
Time frame: 2 months
Occurrence of cerebrovascular disorder
Time frame: 2 months
Occurrence of serotonin syndrome
Time frame: 2 months
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 20 May 2013.
- BackgroundTakao Takeshima, Atsuko Ishida, Terufumi Hara. Drug Use Investigation on Naratriptan Tablets (Amerge®) in Patients with Migraine. [Prog Med]. 2012;32(8):95-105.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by GlaxoSmithKline.
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 2 inclusion and 7 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The number of incidence of adverse events in subjects with migraine headache (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01376193, which also lists 1 linked publication.
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 20 May 2013.