MigraineSTARTNCT00725140
Standardized sTudy With Almotriptan in eaRly Treatment of Migraine
An observational study of Migraine, run by Almirall, S.A. at 3 sites in 3 countries.
Trial summary
This is a observational, open, prospective, single arm cohort study within authorized SPC conditions to describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- How many people
- 501 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2008to Jul 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Following SPC conditions and study requirements, male or female of 18 to 65 years old with a minimum of one year of migraine history (International Headache Society criteria, see criteria attached in the protocol Annex 1) of moderate or severe intensity and with a frequency of 2 to 6 attacks per month for the past 3 months.
Who may be able to join
- History of a confirmed diagnosis of migraine that meets the IHS diagnosis criteria of migraine with or without aura for at least one year.
- Patients with a history of migraine headaches progressing from mild to at least moderate pain intensity if untreated on a scale of no pain (0), mild (1), moderate (2), or severe (3) within the past year.
- Migraine headache frequency of 2 to 6 per month for the past 3 months.
- Male or female aged 18 to 65 years.
- Able to differentiate a migraine headache from an interval (e.g., tension-type) headache.
- 8.Female patients of childbearing potential must not suspect to be pregnant and have an effective method of birth control for at least 30 days prior to study entry and throughout the study.
- 11.After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.
- 12.Patients must either use Almotriptan for their migraine acute attacks treatment or prove through the ANAES scale in the basal visit that a change in their treatment approach is required.
Who cannot join
- Patients, who in the opinion of the investigator, should not be enrolled in the study because of the precautions, warnings or contraindications sections of the Almotriptan Summary of Product Characteristics.
- Patients who have had 15 or more headache days per month in the previous 6 months (chronic daily headache), or patients having a migraine headache frequency of more than 6 per month for the past 3 months.
- Patients with onset of migraine after age 50.
- Patients who routinely experience any other type of headache that would confound discrimination from a migraine.
- Patients who have exclusively migraine aura without headache.
- Patients who typically experience vomiting with their headaches.
Show all 13Show fewer
- Patients with hemiplegic or basilar type migraines.
- Patients who typically have headaches that occur predominantly upon awakening in the morning.
- Patients who have previously discontinued Almotriptan therapy due to an adverse event or lack of efficacy.
- 11.Patients taking any of the prohibited concomitant medications listed in Section 10.3.1 of the protocol.
- 12.Patients who have used any of the following medications within 7 days of study entry and during the trial: sustained release opioids and/or semi-synthetic or long acting opioids.
- 16.Women who are pregnant or lactating.
- 18.Patients who have received an investigational drug or used an investigational device within 30 days of study entry.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Standardized sTudy With Almotriptan in eaRly Treatment of Migraine, START. An International, Open-label, Single Arm, Effectiveness and Safety Study of Almotriptan in Primary Care Setting
This is a observational, open, prospective, single arm cohort study within authorized SPC conditions to describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.
Read the detailed description
Primary Objective:
To describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.
Secondary Objectives:
- Influence of an educational intervention on the early intake of the treatment
- Influence of medication history or concomitant medication on treatment results
- Influence of migraine triggers on treatment results
- Influence of stress on treatment results
- Tolerability profile validation
- Patients' satisfaction
- Reasons for delaying migraine treatment intake
- Conditions
- Migraine
- Keywords
- Migraine, Early intervention, Primary Care, Almotriptan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Free
Measured: 2 h from intake
Secondary outcomes (10)
Sustained Pain Free
Measured: 24 h
SNAE (Sustained pain free and No Adverse Events)
Measured: 24 h
Relapse
Measured: 24 h
Second tablet / rescue medication use
Measured: 24 h
Associated symptoms presence evolution: Nausea, Vomiting, Photophobia, Phonophobia.
Measured: Basal - 2h - 24h
Migraine attack duration
Measured: 24 h
Time loss (functional disability)
Measured: 24 h
Patients' satisfaction:
Measured: Basal - After each attack
Adverse Events
Measured: From recruitment to study end or AE resolution
Consistency of response to treatment between attacks (2 h PF in 2/3 attacks)
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 posted30 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2009
- Study completionJul 2009
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 Almirall, S.A.The 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Lanteri-Minet, Dr, Study chair, Pain Evaluation and Treatment Department, Hopital Pasteur, Nice, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725140
- Sponsor's protocol ID
- M/31416/51
- Other IDs
- EudraCT: 2007-003392-39, Spanish AEM: ALM-ALM-2008-01
- Acronym
- START
- Status last verified
- May 2015
- First submitted
- 29 Jul 2008
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lanteri-Minet M, Diaz-Insa S, Leone M, Vila C, Clissold SP; START Study. Efficacy of almotriptan in early intervention for treatment of acute migraine in a primary care setting: the START study. Int J Clin Pract. 2010 Jun;64(7):936-43. doi: 10.1111/j.1742-1241.2010.02379.x.
PubMed 20584227
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized sTudy With Almotriptan in eaRly Treatment of Migraine, START. An International, Open-label, Single Arm, Effectiveness and Safety Study of Almotriptan in Primary Care Setting
- ClinicalTrials.gov ID
- NCT00725140
- Acronym / sponsor ID
- START / M/31416/51
- Conditions
- Migraine
- Keywords
- Migraine, Early intervention, Primary Care, Almotriptan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 30 Jul 2008 (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 observational, open, prospective, single arm cohort study within authorized SPC conditions to describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.
Detailed description
Primary Objective:
To describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.
Secondary Objectives:
- Influence of an educational intervention on the early intake of the treatment
- Influence of medication history or concomitant medication on treatment results
- Influence of migraine triggers on treatment results
- Influence of stress on treatment results
- Tolerability profile validation
- Patients' satisfaction
- Reasons for delaying migraine treatment intake
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Following SPC conditions and study requirements, male or female of 18 to 65 years old with a minimum of one year of migraine history (International Headache Society criteria, see criteria attached in the protocol Annex 1) of moderate or severe intensity and with a frequency of 2 to 6 attacks per month for the past 3 months.
Key inclusion criteria (8 listed)
- History of a confirmed diagnosis of migraine that meets the IHS diagnosis criteria of migraine with or without aura for at least one year.
- Patients with a history of migraine headaches progressing from mild to at least moderate pain intensity if untreated on a scale of no pain (0), mild (1), moderate (2), or severe (3) within the past year.
- Migraine headache frequency of 2 to 6 per month for the past 3 months.
- Male or female aged 18 to 65 years.
- Able to differentiate a migraine headache from an interval (e.g., tension-type) headache.
Key exclusion criteria (13 listed)
- Patients, who in the opinion of the investigator, should not be enrolled in the study because of the precautions, warnings or contraindications sections of the Almotriptan Summary of Product Characteristics.
- Patients who have had 15 or more headache days per month in the previous 6 months (chronic daily headache), or patients having a migraine headache frequency of more than 6 per month for the past 3 months.
- Patients with onset of migraine after age 50.
- Patients who routinely experience any other type of headache that would confound discrimination from a migraine.
- Patients who have exclusively migraine aura without headache.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Free
Time frame: 2 h from intake
10 secondary outcomes
Sustained Pain Free
Time frame: 24 h
SNAE (Sustained pain free and No Adverse Events)
Time frame: 24 h
Relapse
Time frame: 24 h
Second tablet / rescue medication use
Time frame: 24 h
Associated symptoms presence evolution: Nausea, Vomiting, Photophobia, Phonophobia.
Time frame: Basal - 2h - 24h
Migraine attack duration
Time frame: 24 h
Time loss (functional disability)
Time frame: 24 h
Patients' satisfaction:
Time frame: Basal - After each attack
Adverse Events
Time frame: From recruitment to study end or AE resolution
Consistency of response to treatment between attacks (2 h PF in 2/3 attacks)
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 1 Jun 2015.
- Derived from this study: PubMed 20584227Lanteri-Minet M, Diaz-Insa S, Leone M, Vila C, Clissold SP; START Study. Efficacy of almotriptan in early intervention for treatment of acute migraine in a primary care setting: the START study. Int J Clin Pract. 2010 Jun;64(7):936-43. doi: 10.1111/j.1742-1241.2010.02379.x.
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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.
Michel Lanteri-Minet, Dr study chair
Pain Evaluation and Treatment Department, Hopital Pasteur, Nice, France
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Almirall, S.A. at 3 sites in 3 countries.
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 8 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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Italy, Spain. 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.
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?
Pain Free (time frame: 2 h from intake). 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 NCT00725140, 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 1 Jun 2015.