Standardized sTudy With Almotriptan in eaRly Treatment of Migraine

Condition(s) targeted: Migraine

Phase: N/A

Status: Recruiting

Sponsored by: Laboratorios Almirall, S.A.

Official(s) and/or principal investigator(s):
Michel Lanteri-Minet, Dr, Study Chair, Affiliation: Pain Evaluation and Treatment Department, Hopital Pasteur, Nice, France

Overall contact:
Carlos - Vila, Dr., Phone: (+34) 93 291 34 90, Ext: -, Email: carlos.vila@almirall.es

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.

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

Study design: Cohort, Prospective

Primary outcome: Pain Free

Secondary outcome:

Sustained Pain Free

SNAE (Sustained pain free and No Adverse Events)

Relapse

Second tablet / rescue medication use

Associated symptoms presence evolution: Nausea, Vomiting, Photophobia, Phonophobia.

Migraine attack duration

Time loss (functional disability)

Patients' satisfaction:

Adverse Events

Consistency of response to treatment between attacks (2 h PF in 2/3 attacks)

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:

1. Influence of an educational intervention on the early intake of the treatment

2. Influence of medication history or concomitant medication on treatment results

3. Influence of migraine triggers on treatment results

4. Influence of stress on treatment results

5. Tolerability profile validation

6. Patients' satisfaction

7. Reasons for delaying migraine treatment intake

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. 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. Migraine headache frequency of 2 to 6 per month for the past 3 months.

4. Male or female aged 18 to 65 years.

5. 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.

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.

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.

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.

Carlos - Vila, Dr., Phone: (+34) 93 291 34 90, Ext: -, Email: carlos.vila@almirall.es

28 GPs across France, 28, France; Recruiting

26 GPs across Italy, Diverse, Italy; Recruiting

26 GP practices across Spain, 26, Spain; Recruiting
26 GPs 26 GPs, Principal Investigator

Starting date: June 2008
Ending date: April 2009
Last updated: July 29, 2008