Migraine with and without aura (G 43.0 and G 43.1)
Conditions
Interventions
Trade Name: Zomig Nasal
Product Name: zolmitriptan
Pharmaceutical Form: Nasal spray*
INN or Proposed INN: ZOLMITRIPTAN
CAS Number: 139264178
Other descriptive name: Zomig Nasal
Concentration unit: mg
Sponsors
Carl Dahlöf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of migraine with or without aura as per IHS guidelines • Men or women aged between 18–65 years. • Naive to zolmitriptan nasal spray. • At least a 1-year history of migraine, with on average 1–4 attacks per month. • Ability to distinguish migraine headaches from other types of headache. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant women, and those likely to become pregnant during the investigation. • Breast-feeding mothers. • Patients with contraindications to receiving zolmitriptan / sumatriptan • History of significant psychiatric illness, or any other illness that may affect the interpretation of the results. • Abuse of ergotamine, triptans, alcohol, or other recreational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare patient preference and efficacy for zolmitriptan nasal spray and sumatriptan RDT 100 mg, and the reasons underlying preference. ;Secondary Objective: ;Primary end point(s): Formulation preferred by the patients. | — |
Countries
Sweden
Outcome results
None listed