Standardized sTudy With Almotriptan in eaRly Treatment of Migraine

Migraine Clinical Trial

— START  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725140
• Other study ID #: M/31416/51
• Secondary ID: EudraCT: 2007-00
• Status: Completed
• Phase: N/A
• First received: July 29, 2008
• Last updated: May 29, 2015
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: May 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesFrance: Ministry of HealthItaly: Ministry of Health
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Locations

Country	Name	City	State
France	28 GPs across France	Diverse
Italy	26 GPs across Italy	Diverse
Spain	26 GP practices across Spain	Diverse

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Countries where clinical trial is conducted

France,  Italy,  Spain, 

Outcome

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