1. Home
  2. Approved trials
  3. » فارسی

Investigation of the prophylactic effects of lisinopril in comparison to placebo on chronic migraine

Protocol summary

Summary
In this study we aim at investigating efficacy of prophylactic Lisinopril, an inhibitor ACE, in comparison with placebo in the alleviation of migraine headaches in patients with chronic migraine in a randomized, double-blind. The main objective of the study is to explore the effects of prophylactic Lisinopril vs. placebo in reducing the frequency and severity of chronic headache in migraineurs referred to specialized clinics. Other study objectives include comparing the effects of Lisinopril and placebo in reducing the use of medications during attacks, remission from chronic migraine to episodic migraine, improving migraine associated complications, and improving quality of life in the patients. 112 patients with chronic migraine will be recruited in a randomized double-blind clinical trial. After obtaining the informed consent form from patients, they will be randomly allocated to placebo group or Lisinopril 10 mg taking group. Patients will be included in the study due to the following inclusion Criteria: having ≥ 15 headache days per month for at least 3 months, history of migraine for at least 1 year, age 18-45 years, systolic blood pressure between 110-140 mmHg and taking a large amount of abortive drugs. . The exclusion criteria were as follows: having psychiatric illness, having major neurological disorders and / or other chronic or systemic diseases, being pregnant or have a planned pregnancy, breastfeeding, taking prophylactic medications in the last 4 weeks, suffering from impaired liver function or kidney disorders, allergies to ACE inhibitors, history of angionearotic edema and suffering from secondary headaches. will be asked not to continue any previous medication for migraine . At the same time with prophylactic treatment (lisinopril or placebo) in both groups, 4 capsules of Celebrex 100-milligram per day, thereafter the dosage will be reduced by 100-mg (1 capsule) each 5-day to zero over the first 20 days of the study. Duration of the study will be 12 weeks and headache characteristics as well as drug response and quality of life will be assessed in the second week and at the end of each month during the study.

General information

Acronym
Prophylactic effects of lisinopril on chronic migraine
IRCT registration information
IRCT registration number: IRCT201701089157N5
Registration date: 2017-06-14, 1396/03/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Prof Mansoureh Togha
Name of organization / entity
Neurology department, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 2052
Email address
toghae@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iranian Center of Neurological Research, Tehran University of Medical Sciences
Expected recruitment start date
2017-06-20, 1396/03/30
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the prophylactic effects of lisinopril in comparison to placebo on chronic migraine
Public title
Investigation of the prophylactic effects of lisinopril on chronic migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Patients will be included in the study due to the following inclusion Criteria: having ≥ 15 headache days per month for at least 3 months, history of migraine for at least 1 year, age 18-45 years, systolic blood pressure between 110-140 mmHg Taking a large amount of abortive drugs. The exclusion criteria were as follows: having psychiatric illness, having major neurological disorders and / or other chronic or systemic diseases, being pregnant or have a planned pregnancy, breastfeeding, taking prophylactic medications in the last 4 weeks, suffering from impaired liver function or kidney disorders, allergies to ACE inhibitors, history of angionearotic edema suffering from secondary headaches.
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qhods St., Keshavarz Boulevard
City
tehran
Postal code
Approval date
2017-01-07, 1395/10/18
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1418

Health conditions studied

1

Description of health condition studied
migraine
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
migraine headache severity
Timepoint
first month, second month, third month
Method of measurement
Visual Analog Scale (VAS)

2

Description
Migraine headache duration
Timepoint
first month, second month, third month
Method of measurement
Migraine headache diary

3

Description
Migraine headache frequency
Timepoint
first month, second month, third month
Method of measurement
Migraine headache diary

Secondary outcomes

1

Description
Remission from Chronic Migraine to Episodic Migraine
Timepoint
first week, second month
Method of measurement
physical examination, headache diary

Intervention groups

1

Description
After the eligibility criteria will be applied, 112 chronic migraineurs will be selected and randomly allocated to placebo or intervention groups. Upon admission, a headache questionnaire will be given to all patients to fill out the characteristics of headaches experienced in the past month (including severity and duration of each attack). Also they will be asked not to take any medication for migraine prophylaxis and or analgesic drugs. Patients in the intervention group (n=56) will be instructed to take a tablet of Lisinopril 5 mg per day at the first week and to use 1 tablet each 12-hour thereafter (2 tablets per day from the second week to the end of the 12th week). At the same time from the beginning of the study, 4 capsules of Celebrex 100-milligram per day, thereafter the dosage will be reduced by 100-mg (1 capsule) each 5-day to zero over the first 20 days of the study. In the second week of the study the patients will be physically examined. Duration of the study will be 12 weeks and headache characteristics as well as drug response and quality of life will be assessed at the end of each month during the study.
Category
Treatment - Drugs

2

Description
After the eligibility criteria will be applied, 112 chronic migraineurs will be selected and randomly allocated to placebo or intervention groups. Upon admission, a headache questionnaire will be given to all patients to fill out the characteristics of headaches experienced in the past month (including severity and duration of each attack). Also they will be asked not to take any medication for migraine prophylaxis and or analgesic drugs. Patients in the placebo group (n=56) will be instructed to take a tablet of placebo per day at the first week and to use 1 tablet each 12-hour thereafter (2 tablets per day from the second week to the end of the 12th week). At the same time from the beginning of the study, 4 capsules of Celebrex 100-milligram per day, thereafter the dosage will be reduced by 100-mg (1 capsule) each 5-day to zero over the first 20 days of the study. In the second week of the study the patients will be physically examined. Duration of the study will be 12 weeks and headache characteristics as well as drug response and quality of life will be assessed at the end of each month during the study.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital, headache clinic
Full name of responsible person
Prof. Mansoureh Togha
Street address
Sina hospital, Hasan bad Sq, Imam Khomeini Ave,Tehran Iran
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian Center of Neurological Research, Tehran University of Medical Sciences,
Full name of responsible person
Mrs. Bahareh Pourghaz
Street address
Imam Khomeini Hospital, Iranian Center of Neurological Research, Tehran University of Medical Sciences,
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian Center of Neurological Research, Tehran University of Medical Sciences,
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Prof. Mansoureh Togha
Position
Professor of Neurology
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
tehran
Postal code
1136746911
Phone
+98 21 6670 2052
Fax
+98 21 6634 8553
Email
toghae@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sina Hospital, Iranian Center of Neurological Research,Tehran University of Medical Sciences
Full name of responsible person
Prof. Mansoureh Togha
Position
Professor of Neurology
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
tehran
Postal code
1136746911
Phone
+98 21 6670 2052
Fax
+98 21 6634 8553
Email
toghae@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sina hospital , Iranian Center of Neurological Research,Tehran University of Medical Sciences
Full name of responsible person
Prof. Mansoureh Togha
Position
Professor of Neurology
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
tehran
Postal code
Phone
+98 21 6670 2052
Fax
+98 21 6634 8553
Email
toghae@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...