Treatment of Acute Migraine when Pain is Mild versus when Pain is Moderate to Severe: an Almotriptan Parallel, Placebo Controlled Clinical Trial Act when mild?”

Phase 1

• Conditions: Acute treatment of the headache phase of migraine attacks with or without aura; MedDRA version: 7.1 Level: PT Classification code 10027599

• Registration Number: EUCTR2004-005285-20-GB
• Lead Sponsor: Almirall Prodesfarma, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-21
• Study Completion: 2006-05-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 484

Inclusion Criteria

1. Subjects must have a history of a confirmed diagnosis of migraine that meets the IHS diagnosis criteria for the classification 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 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 have had a history of duration of untreated or unsuccessfully treated migraine headache of 4 hours or longer in the past.
5. Patients must be male or female aged 18 to 65 years.
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 trial because of the precautions, warnings or contraindications sections of the almotriptan Summary of Product Characteristics (see Appendix 3 of the protocol).
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 headache (e.g., headaches related to allergies, food, alcohol, and/or medications, sinus headaches, withdrawal headaches related to changes in the normal intake of substances such as caffeine or nicotine, rebound headaches due to overuse of certain headache medications), or tension-type headache for more than four days per month for the past 3 months.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Safety;Primary end point(s): Number and percentage of patients being pain free at 2 hours after IMP administration.;Main Objective: To evaluate the efficacy of Almotriptan in patients with a history of migraine headache pain reaching at least a moderate intensity when treatment is administered while headache pain is still mild (and during the first hour of pain onset) and when treatment is administered while migraine pain has become moderate or severe.