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 - START

• Conditions: 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.; MedDRA version: 9.1Level: LLTClassification code 10027599Term: Migraine

• Registration Number: EUCTR2007-003392-39-IT
• Lead Sponsor: aboratorios Almirall S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Subjects must have a history of a confirmed diagnosis of migraine that meets the IHS diagnosis criteria of migraine with or without aura for at least one year. 2. 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. 3. Patients must have a migraine headache frequency of 2 to 6 per month for the past 3 months. 4. Patients must be male or female aged 18 to 65 years. 5. Patients must be able to differentiate a migraine headache from an interval (e.g., tension-type) headache. 6. Patients may take a single medication effective for migraine prophylaxis, for any reason. If taking a medication effective for migraine prophylaxis, subjects must have been taking a maintenance dose for at least 1 month prior to the Screening Visit, and must remain on this stable dose for the duration of the trial. 7. Patients must be in generally good health as confirmed by medical and medication history, and baseline physical examination including vital signs. 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 (see note below). 9. Patients must be able to take oral medication, adhere to medication regimens, and perform study procedures. 10. Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the patient?s diary required by the protocol. 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. Note: Female patients of childbearing potential should be practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilisation) or hormonal contraceptives (i.e., oral contraceptives, contraceptive injections, contraceptive patch, contraceptive vaginal ring) for at least 30 days prior to study entry and throughout the study; or be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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 (see protocol appendix). 2. 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. 3. Patients with onset of migraine after age 50. 4. Patients who routinely experience any other type of headache that would confound discrimination from a migraine. 5. Patients who have exclusively migraine aura without headache. 6. Patients who typically experience vomiting with their headaches. 7. Patients with hemiplegic or basilar type migraines. 8. Patients who typically have headaches that occur predominantly upon awakening in the morning. 9. Patients who have previously discontinued Almotriptan therapy due to an adverse event or lack of efficacy. 10. Patients having started a new medication/s for any reason which is effective for the prophylaxis of migraine headache within 30 days of study entry (e.g. certain antiepileptic drugs, beta blockers, tricyclic antidepressants or calcium channel blockers) 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. 13. Patients who require or overuse the following medications for any reason: NSAIDs, COX-2 selective inhibitors, aspirin*, paracetamol (acetaminophen), benzodiazepines (except anxiolytic/hypnotic uses) or antiemetics (more than 3 days per week); opioids, triptans (5-HT1B/1D receptor agonists) or ergotamine type medications (more than 2 days per week). *A stable, low dose of aspirin (≤ 325 mg per day) for cardiac prophylaxis is permitted (see Protocol, Section 10.C). 14. Patients starting nonpharmacologic approaches for migraine treatment (e.g., acupuncture, biofeedback, chiropractic methods) within 14 days of Basal Visit. However, subjects using nonpharmacologic approaches for at least 14 days prior to Basal Visit and intend to maintain the same approaches for the duration of the study, will be permitted to enter the trial. Nonpharmacologic approaches cannot be started during the study. 15. Patients known to have any significant, unstable medical disease (see Almotriptan SPC, attachment) 16. Women who are pregnant or lactating. 17. Patients who have a current or recent history, or suspected history, of substance dependence or abuse within the past 6 months. 18. Patients who have received an investigational drug or used an investigational device within 30 days of study entry. 19. Patients unsuitable for the study for other reasons considered by the investigator as being relevant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified