Migraine DisordersPhase 3NCT00356603
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
A Phase 3 study testing Sumatriptan Succinate in people with Migraine Disorders, run by GlaxoSmithKline at 4 sites in Japan.
Trial summary
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Sumatriptan Succinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesJapan
- Study dates
- 20 Jun 2006to 7 Aug 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of migraine (with or without aura) or cluster headache according to the International Classification of Headache Disorders, Version 2 (ICHD-II)
- History of migraine or cluster headache persisting for at least 6 months
- Migraine: One to 6 attacks of moderate or severer headaches per month during the 2 months prior to enrollment
- Cluster Headache: Each attack persisting for at least 45 minutes
- Written informed consent obtained from the patient. When a patient is a minor, written informed consent from his/her proxy consenter (e.g., person with parental authority) will also be required.
Who cannot join
- History of hypersensitivity to any of the ingredients of 5-HT1B/1D receptor antagonists (e.g., triptans) or serious AE due to treatment with these drugs
- History of serious adverse event attributable to treatment with Imigran® Injection 3
- History of myocardial infarction, current or previous history of ischemic heart disease or its symptoms/signs, or current history of atypical variant angina (coronary arteriospasm)
- Previous history of cerebrovascular disorder or transient cerebral ischemic attack
- Current or previous history of peripheral angiopathy (including Raynaud's syndrome)
- Systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >95 mmHg at the start of treatment period
Show all 13Show fewer
- Current familial hemiplegic migraine, basilar migraine, or sporadic hemiplegic migraine
- Current abuse of ergotamine- or dihydroergotamine-containing preparations or triptans
- Pregnant women, lactating mothers, women who may be pregnant, or women of childbearing potential using no appropriate contraceptive measures.
- Epilepsy or organic cerebral disorder which may lead to convulsion
- Previous history of hypersensitivity to sulfonamides
- Known drug allergy or idiosyncrasies
- Known drug dependency or alcoholism
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
GSK Investigational Site
Aichi, 450-0002
GSK Investigational Site
Hyōgo, 663-8204
GSK Investigational Site
Kyoto, 600-8811
GSK Investigational Site
Tokyo, 105-7103
About this study
Official title: Imigran STATdose - Japan Clinical Experience Study for Self-injection
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.
- Conditions
- Migraine Disorders
- Being tested
- Sumatriptan Succinate
- Keywords
- Migraine, Sumatriptan Succinate Injection Kit, Cluster Headache, self-injection
- Medical subject headings
- Migraine Disorders, Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumatriptan SuccinateDrug
Sumatriptan Succinate
| Study group | Role | What they receive |
|---|---|---|
| Sumatriptan | Experimental | Sumatriptan Receives: Drug: Sumatriptan Succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
Measured: 30 minutes or 60 Minutes after each administration
Secondary outcomes (2)
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was "Was the kit product easy to use?", question 2 was "Do you want to use the kit product in the future?" and question 3 was "Do you consider that the kit product is necessary for the treatment of your illness?". The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented.
Measured: Up to 2 months
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate
The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study start20 Jun 2006
- Primary completion7 Aug 2006
- Study completion7 Aug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT00356603
- Sponsor's protocol ID
- STA106711
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2006
- Last updated
- 4 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imigran STATdose - Japan Clinical Experience Study for Self-injection
- ClinicalTrials.gov ID
- NCT00356603
- Acronym / sponsor ID
- STA106711
- Conditions
- Migraine Disorders
- Keywords
- Migraine, Sumatriptan Succinate Injection Kit, Cluster Headache, self-injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2006 (actual)
- Primary completion
- 7 Aug 2006 (actual)
- Study completion
- 7 Aug 2006 (actual)
- First posted
- 26 Jul 2006 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan | Experimental | Drug: Sumatriptan SuccinateSumatriptan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of migraine (with or without aura) or cluster headache according to the International Classification of Headache Disorders, Version 2 (ICHD-II)
- History of migraine or cluster headache persisting for at least 6 months
- Migraine: One to 6 attacks of moderate or severer headaches per month during the 2 months prior to enrollment
- Cluster Headache: Each attack persisting for at least 45 minutes
- Written informed consent obtained from the patient. When a patient is a minor, written informed consent from his/her proxy consenter (e.g., person with parental authority) will also be required.
Key exclusion criteria (13 listed)
- History of hypersensitivity to any of the ingredients of 5-HT1B/1D receptor antagonists (e.g., triptans) or serious AE due to treatment with these drugs
- History of serious adverse event attributable to treatment with Imigran® Injection 3
- History of myocardial infarction, current or previous history of ischemic heart disease or its symptoms/signs, or current history of atypical variant angina (coronary arteriospasm)
- Previous history of cerebrovascular disorder or transient cerebral ischemic attack
- Current or previous history of peripheral angiopathy (including Raynaud's syndrome)
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 |
|---|---|---|
| Sumatriptan SuccinateSumatriptan Succinate | Drug | Sumatriptan |
Primary outcome
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)
Time frame: 30 minutes or 60 Minutes after each administration
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
2 secondary outcomes
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Time frame: Up to 2 months
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate
Time frame: Up to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sumatriptan Succinate in people with Migraine Disorders, run by GlaxoSmithKline at 4 sites in Japan.
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 5 inclusion and 13 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 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) (time frame: 30 minutes or 60 Minutes after each administration). 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 4 Sep 2018.