Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura
|First Received Date ICMJE||July 29, 2005|
|Last Updated Date||August 16, 2005|
|Start Date ICMJE||February 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Percentage of attacks that were "pain free" at t = 120 minutes without using rescue medication|
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00126035 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura|
|Official Title ICMJE||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|
|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.|
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;
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Migraine With Typical Aura|
|Intervention ICMJE||Device: Migraid|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||December 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Netherlands|
|Removed Location Countries|
|NCT Number ICMJE||NCT00126035|
|Other Study ID Numbers ICMJE||03-MIG-01|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Profess Medical Consultancy|
|Collaborators ICMJE||Not Provided|
|PRS Account||Profess Medical Consultancy|
|Verification Date||July 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP