Standardized sTudy With Almotriptan in eaRly Treatment of Migraine

Completed

• Conditions: Migraine

• Registration Number: NCT00725140
• Lead Sponsor: Almirall, S.A.

Brief 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.

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

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-29
• Study First Posted: 2008-07-30
• Primary Completion: 2009-04
• Study Completion: 2009-07
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Free	2 h from intake

Secondary Outcome Measures

Name	Time	Method
Sustained Pain Free	24 h
SNAE (Sustained pain free and No Adverse Events)	24 h
Time loss (functional disability)	24 h
Consistency of response to treatment between attacks (2 h PF in 2/3 attacks)	2 months
Associated symptoms presence evolution: Nausea, Vomiting, Photophobia, Phonophobia.	Basal - 2h - 24h
Migraine attack duration	24 h
Adverse Events	From recruitment to study end or AE resolution
Second tablet / rescue medication use	24 h
Relapse	24 h
Patients' satisfaction:	Basal - After each attack

Trial Locations

Locations (3)

26 GPs across Italy; 🇮🇹 Diverse, Italy

26 GP practices across Spain; 🇪🇸 Diverse, Spain

28 GPs across France; 🇫🇷 Diverse, France