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Design, fabrication and evaluation of physical and chemical properties and evaluation of the clinical effect of formulation of targeted cerebral drug delivery system through the nose containing Sumatriptan in acute migraine attacks

Design, fabrication and evaluation of physical and chemical properties and evaluation of the clinical effect of formulation of targeted cerebral drug delivery system through the nose containing Sumatriptan in acute migraine attacks

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180120038450N4
Enrollment
73
Registered
2022-04-03
Start date
2022-02-20
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute migraine attack. Migraine

Interventions

Intervention 1: Group 1: 37 people are non randomized selected and use Sumatriptan nasal spray(10mg) in the first two migraine attacks and Sumatriptan oral tablet (50mg)in the next two attacks. Int

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients with 2 to 8 migraine attacks per month History of more than one year with migraine(with aura or without aura)

Exclusion criteria

Exclusion criteria: Pregnancy History of high blood pressure History of myocardial infarction History of stroke Allergy to sumatriptan History of coronary artery disease History of congenital heart disease Cardiovascular disease Pulmonary disease Cardiac arrhythmias Angina Cerebrovascular disease

Design outcomes

Primary

MeasureTime frame
Migraine headache condition. Timepoint: Before the intervention and a month later. Method of measurement: Visual Analogue Scale/Headache Impact Test.

Secondary

MeasureTime frame
Adverse effect. Timepoint: At the onset of a migraine attack up to two hours after taking the drug. Method of measurement: Side effects questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzar mollaei

Kermanshah University of Medical Sciences

azar_mollaei_98@yahoo.com+98 87 3352 2321

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026