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Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura

Primary Purpose

Migraine With Typical Aura

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Migraid
Sponsored by
Profess Medical Consultancy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With Typical Aura focused on measuring Acute Migraine, Device, Migraid, Treatment, Aura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a current history of migraine with typical aura where the aura is usually followed by headache according to the International Headache Society (IHS) criteria. Patients are male or female. N.B. When female patients are treated for migraine attacks with triptans then the required precautions and safety measures should be taken in order to prevent pregnancy. Patients with an age between 18 and 65 years. Patients must have experienced 1-4 moderate (grade 2) or severe (grade 3) migraine attacks per month for at least two months prior to entry into the study. Patients must be willing to keep their prophylactic drug treatment for migraine unchanged. Patients must be able to distinguish migraine headaches from other headache types (e.g. tension-type headaches) at the onset of a migraine attack. Patients must be able to understand and complete the diary card Patients must be willing and able to give written informed consent prior to entry into the study. Patients must be willing and able to carry the Migraid and, if necessary, apply it in a public place. Exclusion Criteria: Migraine patients with a typical aura but without any migraine headache thereafter. Patients with a history suggestive of ischaemic heart disease (IHD) or any present evidence of ischaemic heart disease (like angina pectoris, previous myocardial infarction, documented silent ischaemia, Prinzmetal's angina), or symptoms consistent with IHD. Patients suffering from coronary vasospasm or any atherosclerotic disease (cerebrovascular disease [CVD], peripheral vascular disease [PVD] or Raynaud's disease) which places them at increased risk of coronary ischaemia. Patients with a history of cerebrovascular accident (CVA) or transient ischaemic attacks (TIA). Patients with a supine diastolic blood pressure of > 95 mm Hg and/or systolic blood pressure > 160 mm Hg (treated or untreated) at Visit 1. Patients with a history of epilepsy or structural brain lesions which lower their convulsion threshold. Patients with tension-type headaches > 15 days/month in either of the two months prior to the study. Current abuse of opioid analgesics or other psychotropic drugs. History (within the past year) or current abuse of ergotamine (abuse as defined as > 10 mg/week). Current abuse of alcohol (according to local recommendations) or other drugs. Patients suffering from any severe concurrent medical condition which may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in a clinical study. Patients with a history of ophthalmoplegic, basilar or hemiplegic migraine. Patients with a history of impaired hepatic or renal function. Patients who have participated in a clinical trial within the previous 3 months or are planning to participate in another clinical research study at any time during this study. Patients with any concurrent medical or psychiatric condition that, in the investigator's opinion, may affect the interpretation of efficacy or safety data or which otherwise contraindicates participation in a clinical trial. Patients cannot be participating investigators, study co-ordinators, employees of investigators, or family members of any of the aforementioned.

Sites / Locations

  • Multicentre study with 21 General practitioners

Outcomes

Primary Outcome Measures

Percentage of attacks that were "pain free" at t = 120 minutes without using rescue medication

Secondary Outcome Measures

Percentage of responders
Percentage of attacks that were "pain free" at t = 30 minutes, t = 60 minutes, t = 90 minutes, t =150 minutes, t =180 minutes and t = 24 hours without using rescue medication
Percentage of attacks that were "sustained pain free" without using rescue medication
Percentage of attacks resulting in "headache relief" at t = 60 minutes, t = 90 minutes, t =120 minutes, t =150 minutes, t =180 minutes and t = 24 hours without using rescue medication
Percentage of attacks resulting in "sustained headache relief" without using rescue medication
Percentage of attacks with relief of nausea and vomiting, photo- and phonophobia at t = 30 minutes, t = 60 minutes, t = 90 minutes, t = 120 minutes, t=180 minutes and t = 24 hours without using rescue medication
Percentage of attacks with return of headache without using rescue medication
Percentage of attacks for which the patient's usual rescue medication is taken
Patient preference, as well as reasons for preference

Full Information

First Posted
July 29, 2005
Last Updated
August 16, 2005
Sponsor
Profess Medical Consultancy
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1. Study Identification

Unique Protocol Identification Number
NCT00126035
Brief Title
Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura
Official Title
Open, Randomised, Multi-Centre, Cross-Over Study to Investigate the Efficacy of the Migraid Device Compared With No Device Treatment in the Acute, Early Treatment of Migraine With Typical Aura
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Profess Medical Consultancy

4. Oversight

5. Study Description

Brief Summary
The purpose of the study was to assess the efficacy of Migraid in terms of preventing headaches in patients with migraine with typical aura. The secondary objectives were to assess whether Migraid is able to achieve pain relief and/or relief of migraine associated symptoms and to evaluate the safety and tolerability of the study treatment.
Detailed Description
Migraid is to be used only once during the aura phase of a migraine attack for a duration of 60 minutes. Reference therapy: No treatment. This means that at random the patient will be allocated to either of the two treatment orders; the first treatment order is to use the Migraid whenever a migraine attack with an aura occurs. During the next migraine attack the Migraid will not be used and vice versa for the other group of patients. Patients will be asked to complete diary cards to record details for each of the two migraine attacks and the severity of the migraine headache at certain points in time: at t = 30 minutes, t = 60 minutes, t= 90 minutes, t =120 minutes, t =150 minutes, t =180 minutes and t = 24 hours. Also, associated symptoms will be asked for. Rescue medication data including name, time taken and amount will also be registered in the diary card. For all primary and secondary variables of efficacy, the following definitions will be used: Grade or score: Pain level: Description 0: None - No pain; Mild - A headache with no remarkable pain that does not hinder you in performing your usual daily activities; Moderate - A headache with pain that hinders you in performing your usual daily activities, but that does necessitate you to go to bed; Severe - A headache with pain that necessitates you to go to or stay in bed. The associated symptoms will be graded as either present or absent. These symptoms are defined to conform to the following table: Symptom: Description Nausea: Sick to the stomach/feel like throwing up; Vomiting: Throwing up or puking; Photophobia: Light bothers or hurts the eyes; Phonophobia: Noise bothers or hurts the ears. A migraine attack is defined as: New onset of migraine pain, preceded by a pain-free period of at least 24-hours duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Typical Aura
Keywords
Acute Migraine, Device, Migraid, Treatment, Aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Migraid
Primary Outcome Measure Information:
Title
Percentage of attacks that were "pain free" at t = 120 minutes without using rescue medication
Secondary Outcome Measure Information:
Title
Percentage of responders
Title
Percentage of attacks that were "pain free" at t = 30 minutes, t = 60 minutes, t = 90 minutes, t =150 minutes, t =180 minutes and t = 24 hours without using rescue medication
Title
Percentage of attacks that were "sustained pain free" without using rescue medication
Title
Percentage of attacks resulting in "headache relief" at t = 60 minutes, t = 90 minutes, t =120 minutes, t =150 minutes, t =180 minutes and t = 24 hours without using rescue medication
Title
Percentage of attacks resulting in "sustained headache relief" without using rescue medication
Title
Percentage of attacks with relief of nausea and vomiting, photo- and phonophobia at t = 30 minutes, t = 60 minutes, t = 90 minutes, t = 120 minutes, t=180 minutes and t = 24 hours without using rescue medication
Title
Percentage of attacks with return of headache without using rescue medication
Title
Percentage of attacks for which the patient's usual rescue medication is taken
Title
Patient preference, as well as reasons for preference

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a current history of migraine with typical aura where the aura is usually followed by headache according to the International Headache Society (IHS) criteria. Patients are male or female. N.B. When female patients are treated for migraine attacks with triptans then the required precautions and safety measures should be taken in order to prevent pregnancy. Patients with an age between 18 and 65 years. Patients must have experienced 1-4 moderate (grade 2) or severe (grade 3) migraine attacks per month for at least two months prior to entry into the study. Patients must be willing to keep their prophylactic drug treatment for migraine unchanged. Patients must be able to distinguish migraine headaches from other headache types (e.g. tension-type headaches) at the onset of a migraine attack. Patients must be able to understand and complete the diary card Patients must be willing and able to give written informed consent prior to entry into the study. Patients must be willing and able to carry the Migraid and, if necessary, apply it in a public place. Exclusion Criteria: Migraine patients with a typical aura but without any migraine headache thereafter. Patients with a history suggestive of ischaemic heart disease (IHD) or any present evidence of ischaemic heart disease (like angina pectoris, previous myocardial infarction, documented silent ischaemia, Prinzmetal's angina), or symptoms consistent with IHD. Patients suffering from coronary vasospasm or any atherosclerotic disease (cerebrovascular disease [CVD], peripheral vascular disease [PVD] or Raynaud's disease) which places them at increased risk of coronary ischaemia. Patients with a history of cerebrovascular accident (CVA) or transient ischaemic attacks (TIA). Patients with a supine diastolic blood pressure of > 95 mm Hg and/or systolic blood pressure > 160 mm Hg (treated or untreated) at Visit 1. Patients with a history of epilepsy or structural brain lesions which lower their convulsion threshold. Patients with tension-type headaches > 15 days/month in either of the two months prior to the study. Current abuse of opioid analgesics or other psychotropic drugs. History (within the past year) or current abuse of ergotamine (abuse as defined as > 10 mg/week). Current abuse of alcohol (according to local recommendations) or other drugs. Patients suffering from any severe concurrent medical condition which may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in a clinical study. Patients with a history of ophthalmoplegic, basilar or hemiplegic migraine. Patients with a history of impaired hepatic or renal function. Patients who have participated in a clinical trial within the previous 3 months or are planning to participate in another clinical research study at any time during this study. Patients with any concurrent medical or psychiatric condition that, in the investigator's opinion, may affect the interpretation of efficacy or safety data or which otherwise contraindicates participation in a clinical trial. Patients cannot be participating investigators, study co-ordinators, employees of investigators, or family members of any of the aforementioned.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joop AM Kuster, MD
Organizational Affiliation
Kennemer Gasthuis Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multicentre study with 21 General practitioners
City
Haarlem
State/Province
Noord Holland
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.migraid.com
Description
new website for the Migraid device

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Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura

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