Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Standardized sTudy With Almotriptan in eaRly Treatment of Migraine (START)

This study has been completed.
Sponsor:
Information provided by:
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT00725140
First received: July 29, 2008
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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.


Condition
Migraine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Pain Free [ Time Frame: 2 h from intake ] [ Designated as safety issue: No ]

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

Enrollment: 501
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Following SPC conditions and study requirements, male or female of 18 to 65 years old with a minimum of one year of migraine history (International Headache Society criteria, see criteria attached in the protocol Annex 1) of moderate or severe intensity and with a frequency of 2 to 6 attacks per month for the past 3 months.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725140

Locations
France
28 GPs across France
28, France
Italy
26 GPs across Italy
Diverse, Italy
Spain
26 GP practices across Spain
26, Spain
Sponsors and Collaborators
Almirall, S.A.
Investigators
Study Chair: Michel Lanteri-Minet, Dr Pain Evaluation and Treatment Department, Hopital Pasteur, Nice, France
  More Information

No publications provided by Almirall, S.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlos Vila, International Medical Advisor, GM&MA, Laboratorios Almirall S.A., Laboratorios Almirall, S.A.
ClinicalTrials.gov Identifier: NCT00725140     History of Changes
Other Study ID Numbers: M/31416/51, EudraCT: 2007-003392-39, Spanish AEM: ALM-ALM-2008-01
Study First Received: July 29, 2008
Last Updated: October 7, 2009
Health Authority: Spain: Spanish Agency of Medicines
France: Ministry of Health
Italy: Ministry of Health

Keywords provided by Almirall, S.A.:
Migraine
Early intervention
Primary Care
Almotriptan

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Almotriptan
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on November 20, 2014