Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Completed NCT05525611 - Cabergoline as a Preventive Treatment for Chronic Migraine N/A
Recruiting NCT03832998 - Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine Phase 3
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Not yet recruiting NCT06428838 - Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context Phase 3
Completed NCT06304675 - Manageable Environmental Factors in Migraine
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Recruiting NCT05517200 - Pilot Study for a Machine Learning Test for Migraine
Completed NCT04179474 - Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine Phase 1
Recruiting NCT04603976 - Registry for Migraine - Clinical Core Phase 4
Completed NCT03597529 - CHOCOlate MeLatonin for AdolescenT MigrainE Phase 2
Completed NCT04197349 - Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman Phase 1
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Active, not recruiting NCT05064371 - Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan Phase 3
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Not yet recruiting NCT04859374 - Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach N/A
Not yet recruiting NCT03083860 - Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions. N/A
Completed NCT02905227 - A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder Phase 1
Enrolling by invitation NCT02532023 - The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients Phase 4
Completed NCT02108678 - One-Day Intervention for Depression and Impairment in Migraine Patients N/A