Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00126035
Status:
COMPLETED
Last Update Posted:
2005-08-17
First Post:
2005-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura
Sponsor:
Profess Medical Consultancy
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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;
1. Mild - A headache with no remarkable pain that does not hinder you in performing your usual daily activities;
2. Moderate - A headache with pain that hinders you in performing your usual daily activities, but that does necessitate you to go to bed;
3. 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.
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;
1. Mild - A headache with no remarkable pain that does not hinder you in performing your usual daily activities;
2. Moderate - A headache with pain that hinders you in performing your usual daily activities, but that does necessitate you to go to bed;
3. 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: