Migraine DisordersNCT01332383
Special Drug Use Investigation for AMERGE® Tablet (Long-term)
An observational study of Migraine Disorders, run by GlaxoSmithKline.
Trial summary
To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Naratriptan
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Oct 2013
- 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: Patients with migraine headache who are naive to AMERGE
Who may be able to join
- Must use AMERGE for the first time
Who cannot join
- Patients with hypersensitivity to naratriptan or any of the components.
- Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
- Patients with history of cerebral vascular disturbance or transient ischaemic attack
- Patients with peripheral vascular syndromes
- Patients with uncontrolled hypertension
- Patients with severe renal or hepatic impairment
- Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication
About this study
Official title: Special Drug Use Investigation for AMERGE Tablet (Long-term)
To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients prescribed AMERGE | Patients with migraine disorders prescribed AMERGE 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 adverse drug reactions and serious adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startMay 2009
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 300 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
- NCT01332383
- Sponsor's protocol ID
- 112925
- Status last verified
- Aug 2015
- First submitted
- 7 Apr 2011
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for AMERGE Tablet (Long-term)
- ClinicalTrials.gov ID
- NCT01332383
- Acronym / sponsor ID
- 112925
- Conditions
- Migraine Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Apr 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.
To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients prescribed AMERGE | – | Drug: NaratriptanPatients with migraine disorders prescribed AMERGE during study period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with migraine headache who are naive to AMERGE
Key inclusion criteria (1 listed)
- Must use AMERGE for the first time
Key exclusion criteria (7 listed)
- Patients with hypersensitivity to naratriptan or any of the components.
- Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
- Patients with history of cerebral vascular disturbance or transient ischaemic attack
- Patients with peripheral vascular syndromes
- Patients with 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 |
|---|---|---|
| Naratriptan | Drug | Patients prescribed AMERGE |
Primary outcome
The number of adverse drug reactions and serious adverse events
Time frame: 6 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 13 Aug 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.
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 1 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 13 Aug 2015. 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 adverse drug reactions and serious adverse events (time frame: 6 months). 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 13 Aug 2015.