Migraine With Typical Aura Clinical Trial
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.
| Status | Completed |
| Enrollment | 134 |
| Est. completion date | December 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Multicentre study with 21 General practitioners | Haarlem | Noord Holland |
| Lead Sponsor | Collaborator |
|---|---|
| Profess Medical Consultancy |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of attacks that were "pain free" at t = 120 minutes without using rescue medication | |||
| Secondary | Percentage of responders | |||
| Secondary | 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 | |||
| Secondary | Percentage of attacks that were “sustained pain free” without using rescue medication | |||
| Secondary | 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 | |||
| Secondary | Percentage of attacks resulting in “sustained headache relief” without using rescue medication | |||
| Secondary | 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 | |||
| Secondary | Percentage of attacks with return of headache without using rescue medication | |||
| Secondary | Percentage of attacks for which the patient’s usual rescue medication is taken | |||
| Secondary | Patient preference, as well as reasons for preference |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03220113 -
Treatment of Chronic Migraine Headaches.
|
Phase 1/Phase 2 |