Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Percentage of attacks that were "pain free" at t = 120 minutes without using rescue medication
- 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
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||December 2004|
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:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126035
|Multicentre study with 21 General practitioners|
|Haarlem, Noord Holland, Netherlands|
|Principal Investigator:||Joop AM Kuster, MD||Kennemer Gasthuis Hospital|