Migraine With Typical AuraNCT00126035
Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura
A study testing Migraid in people with Migraine With Typical Aura, run by Profess Medical Consultancy at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine With Typical Aura
- What is being tested?
- Migraid
- Type of treatment
- Medical device
- How many people
- 134 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2004to Dec 2004
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Multicentre study with 21 General practitioners
Haarlem, North Holland
About this study
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
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.
Read the 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.
- Conditions
- Migraine With Typical Aura
- Being tested
- Migraid
- Keywords
- Acute Migraine, Device, Migraid, Treatment, Aura
- Medical subject headings
- Migraine with Aura, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MigraidDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of attacks that were "pain free" at t = 120 minutes without using rescue medication
Secondary outcomes (9)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startFeb 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With Typical AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 134 participants
Sponsor and investigators
- Lead sponsor
- Profess Medical Consultancy
- Sponsor type
- University, hospital or other
- Investigators
- Joop AM Kuster, MD, Principal investigator, Kennemer Gasthuis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126035
- Sponsor's protocol ID
- 03-MIG-01
- Status last verified
- Jul 2005
- First submitted
- 29 Jul 2005
- Last updated
- 17 Aug 2005
- Results posted
- No