MigrainePhase 3NCT00510419
A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
A Phase 3 study testing "Investigational"Auto-injector (sumatriptan succinate) in people with Migraine, run by Pfizer at 10 sites in United States.
Trial summary
The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack. The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine
- What is being tested?
- "Investigational"Auto-injector (sumatriptan succinate)
- How many people
- 73 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2007to Dec 2007
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults 18 to 60 years of age
- Prior effective use of injectable sumatriptan on at least two occasions within the last two months
- At least two migraines per month suitable injectable sumatriptan
- Capable of using a migraine self-injection auto-injector
- Capable of distinguishing between migraine and other headache types (e.g., tension-type headache)
Who cannot join
- Seizure disorders
- Coronary artery disease (CAD)
- Cardiac dysrhythmia or pacemaker
- High blood pressure
- Liver disease
- Kidney disease
Show all 10Show fewer
- Autoimmune disease
- History of alcohol or substance abuse
- Currently pregnant
- Use of any other investigational drug product within 30 days prior to treatment visit
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104
Diamond Head Clinic
Chicago, Illinois, 60614
Anodyne Headache and Pain Care
Dallas, Texas, 75231
Houston Headache Clinic
Houston, Texas, 77004
Wesley Headache Clinic
Memphis, Tennessee, 38018
University of Pittsburgh Headache Center
Pittsburgh, Pennsylvania, 15213
Road Runner Research, LTD
San Antonio, Texas, 78258
San Francisco Clinical Research Center
San Francisco, California, 94109
Clinvest
Springfield, Missouri, 65807
New England Center for Headache
Stamford, Connecticut, 06902
About this study
Official title: A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack.
The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.
Read the detailed description
Investigational Plan:
- Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug]
- Baseline Visit [Visit 1 / Provision of study drug and subject training]
- Treatment Visit [Visit 2 / within 72 hours after study drug administration]
- Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug administration]
- Conditions
- Migraine
- Being tested
- "Investigational"Auto-injector (sumatriptan succinate)
- Keywords
- Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Investigational"Auto-injector (sumatriptan succinate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.
Secondary outcomes (1)
• Comparison of pain scores pre-dose and 2 hours post-dose. • Preference of investigational auto-injector experience compared to subject's previous self-administration of sumatriptan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2007
- Study completionDec 2007
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 MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510419
- Sponsor's protocol ID
- K644-07-3001
- Status last verified
- Jun 2012
- First submitted
- 1 Aug 2007
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Landy SH, Tepper SJ, Wein T, Schweizer E, Ramos E. An open-label trial of a sumatriptan auto-injector for migraine in patients currently treated with subcutaneous sumatriptan. Headache. 2013 Jan;53(1):118-125. doi: 10.1111/j.1526-4610.2012.02295.x. Epub 2012 Nov 13.
PubMed 23148799
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
- ClinicalTrials.gov ID
- NCT00510419
- Acronym / sponsor ID
- K644-07-3001
- Conditions
- Migraine
- Keywords
- Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 2 Aug 2007 (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 research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack.
The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.
Detailed description
Investigational Plan:
- Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug]
- Baseline Visit [Visit 1 / Provision of study drug and subject training]
- Treatment Visit [Visit 2 / within 72 hours after study drug administration]
- Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug administration]
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults 18 to 60 years of age
- Prior effective use of injectable sumatriptan on at least two occasions within the last two months
- At least two migraines per month suitable injectable sumatriptan
- Capable of using a migraine self-injection auto-injector
- Capable of distinguishing between migraine and other headache types (e.g., tension-type headache)
Key exclusion criteria (10 listed)
- Seizure disorders
- Coronary artery disease (CAD)
- Cardiac dysrhythmia or pacemaker
- High blood pressure
- Liver disease
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 |
|---|---|---|
| "Investigational"Auto-injector (sumatriptan succinate) | Drug | – |
Primary outcome
Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.
1 secondary outcome
• Comparison of pain scores pre-dose and 2 hours post-dose. • Preference of investigational auto-injector experience compared to subject's previous self-administration of sumatriptan.
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 8 Jun 2012.
- Derived from this study: PubMed 23148799Landy SH, Tepper SJ, Wein T, Schweizer E, Ramos E. An open-label trial of a sumatriptan auto-injector for migraine in patients currently treated with subcutaneous sumatriptan. Headache. 2013 Jan;53(1):118-125. doi: 10.1111/j.1526-4610.2012.02295.x. Epub 2012 Nov 13.
Related trials for Migraine
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
RecruitingPhase 3
A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
Acute Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Recruiting
Dietary Intervention for Migraine Relief
Migraine
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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 "Investigational"Auto-injector (sumatriptan succinate) in people with Migraine, run by Pfizer at 10 sites 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 5 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 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
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?
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?
Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.. 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 NCT00510419, 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 8 Jun 2012.