Acute Treatment of Migraine with or without Aura MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Product Name: Migraine Sumatriptan Powder Product
Product Code: MSPP
Pharmaceutical Form: Nasal powder
INN or Proposed INN: sumatriptan succinate
CAS Number: 8000080026
Other descriptive name: SUMATRI
Sponsors
OptiNose UK Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult subjects of either gender, aged 18-65 years. 2. A developing or established attack of migraine with or without aura according to the International Headache Society criteria, of moderate (grade 2) or severe (grade 3) intensity and the attack not improving at the time of assessment. 3. Migraine should have been present for at least 1 year and the subject should have a 3-month well-documented retrospective history. 4. The subject should have 48 hours of freedom from headache between attacks of migraine. 5. The subject’s age at first diagnosis of migraine should be less than 50 years. 6. An average of > 1 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. An inability to distinguish other headaches from migraine. 2. Subjects who have other headaches at a frequency of more than 6 days per month. 3. Subjects who use drugs excessively for headache, that is who use medication for acute headache more than 10 days each month. 4. Subjects who are resistant to migraine drugs. 5. Use of ergotamine, ergot-type medications, any 5-HT1 agonist or narcotic analgesics within the previous 24 hours before treatment. 6. Current use of drugs for migraine prophylaxis. Subjects who have used drugs for migraine prophylaxis in the past but have not done so for 1 month prior to the screening may be included. 7. Use of any analgesic within the previous 12 hours before treatment. 8. Subjects undergoing treatment with monoamine oxidase A (MAO-A) inhibitors or attending for treatment within 2 weeks of discontinuation of MAO-A inhibitor therapy. 9. Subjects undergoing treatment with selective serotonin reuptake inhibitors (SSRIs). 10. Subjects who have taken antipsychotics or antidepressant medications (unless for migraine prophylaxis) during the previous 3 months. 11. Subjects who have used a decongestant within 6 hours of their attendance at the clinic on the treatment day. 12. Subjects with hemiplegic or basilar migraine. 13. Subjects with a history, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes. 14. Subjects with uncontrolled hypertension (baseline systolic/diastolic blood pressure >140/95 mm Hg). 15. Subjects with severe hepatic impairment. 16. Subjects with epilepsy. 17. Subjects with any uncontrolled major psychiatric illness. 18. Subjects who abuse alcohol or other drugs. 19. Subjects with any systemic disease which in the opinion of the Investigator would contraindicate participation. 20. Subjects with a history of hypersensitivity or intolerance to sumatriptan, any of its components or sulphonamides. 21. Pregnant or lactating women. 22. Subjects who have taken any investigational medication within 3 months prior to the study drug (Visit 2), or are scheduled to receive an investigational drug other than sumatriptan while participating in the study. 23. Subjects with known nasal obstruction due to nasal deviations, polyposis, severe mucosal swelling or any other reason. 24. Subjects with current uncontrolled nasopharyngeal illness. 25. Subjects with known velum insufficiency, - i.e. those with cleft palate and/or structural abnormalities in the soft palate and nasopharynx. 26. Subjects who have undergone extensive nasal and/or sinus surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of intranasal sumatriptan at a dose of either 10 mg or 20 mg delivered with the OptiNose powder device during a single migraine episode.;Secondary Objective: To evaluate the safety and tolerability of intranasal sumatriptan at a dose of either 10 mg or 20 mg delivered with the OptiNose powder device during a single migraine episode.;Primary end point(s): - Proportion of subjects treated with sumatriptan pain free at 120 minutes post- dose compared to placebo. - Relief of headache at each timepoint. - Time to meaningful relief. - Level of functional disability. - Requirement for rescue medication. - Incidence of associated symptoms. - Sustained pain free. | — |
Countries
Czech Republic
Outcome results
None listed