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
A clinical trial with two groups of crossover, non randomized, phase 3 on 73 patients
Settings and conduct
Imam Reza Hospital in Kermanshah - the people who enter the study are among those who go to the hospital with a headache complaint and after screening these people are invited to cooperate if they have the conditions to enter the study. Patients are divided into two groups. 37 people in two The first migraine attack uses Sumatriptan 10 mg nasal spray and the next two attacks use 50 mg Sumatriptan oral tablet.
Washing period: Concomitant use of sumatriptan with a monoamine oxidase is contraindicated.
There should be a 24-hour interval between taking sumatriptan with other headache medications such as ergotamine, dihydroargotamine, and methyl ergonovine to prolong the effects of long-term contraction.
Concomitant use of (SSRI )use of with sumatriptan is not recommended .
Concomitant use of cabergoline and bromocriptine is also contraindicated
Participants/Inclusion and exclusion criteria
inclusion:Individuals with 2 to 8 migraine attacks per month and a history of more than one year of migraine
exclusion: History of congenital heart disease,Cardiovascular and Pulmonary disease, treated cardiac arrhythmias, Angina, Cerebrovascular disease-Pregnant patients, History of hypertension, History of stroke Brain, Sumatriptan allergy, History of coronary artery disease
Intervention groups
Intervention group 1: Use of 10 mg nasal spray in the first two Migraine attacks and use of 50 mg oral tablet in the second two Migraine attacks
Intervention group two: using oral tablet in the first two Migraine attacks and using Sumatriptan nasal spray in the second two Migraine attacks
Main outcome variables
Severity of the headache
Side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180120038450N4
Registration date:2022-04-03, 1401/01/14
Registration timing:retrospective
Last update:2022-04-03, 1401/01/14
Update count:0
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Shahla Mirzaeei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3824 0526
Email address
shahlamirzaeei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
73
More than 1 sample in each individual
Number of samples in each individual:
4
Sumatriptan oral tablets and nasal spray
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofkermanshah University of Medical Sciences
Street address
Central Organization of Kermanshah University of Medical Sciences-Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714858743
Approval date
2022-01-03, 1400/10/13
Ethics committee reference number
IR.KUMS.REC.1400.661
Health conditions studied
1
Description of health condition studied
Acute migraine attack
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Migraine headache condition
Timepoint
Before the intervention and a month later
Method of measurement
Visual Analogue Scale/Headache Impact Test
Secondary outcomes
1
Description
adverse effect
Timepoint
At the onset of a migraine attack up to two hours after taking the drug
Method of measurement
Side effects questionnaire
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
The second group: 36 people are randomly selected and in the first two migraine attacks they use Sumatriptan oral tablet(50mg) and in the next two attacks they use Sumatriptan nasal spray(10mg).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza educational hospital, Kermanshah
Full name of responsible person
Payam sariaslani
Street address
Faculty of Pharmacy-Parstar Blvd-Daneshgah St-Shahid Shiroodi Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3426 6780
Email
Shahlamirzaeei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahla mirzaei
Street address
Faculty of Pharmacy-Parstar Blvd-Daneshgah St-Shahid Shiroodi Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Email
shahlamirzaeei@gmail.com
Grant name
120230000rial
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Azar mollaei
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Bustan Girls' Dormitory 2-Nurse Boulevard, in front of Imam Reza Hospital
City
kermanshah
Province
Kermanshah
Postal code
6714438621
Phone
+98 87 3352 2321
Email
azar_mollaei_98@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
shahla mirzaei
Position
Assistant Professor of Pharmaceutics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy-Parstar Blvd-Daneshgah St-Shahid Shiroodi Blvd
City
kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3426 6780
Email
shahlamirzaeei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Azar mollaei
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Bostan Sisters Dormitory 2-Nurse Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714438621
Phone
+98 87 3352 2321
Email
azar_mollaei_98@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available