clinical trial of comparison between intravenous sodium valproate and subcutaneous sumatriptan with intramuscular metoclopramide for treatment of acute attacks in patients with migraine headaches
Triptans and Ergot compounds are currently used as first line agents for treatment of moderate to severe migraine headaches, but each of these drugs have their own limitations and complications. Intravenous Sodium Valproate also is a relatively safe , effective and rapidly acting drug for treatment of migraine attacks according to recent preliminary studies.
In this open-label single-centre randomized prospective phase-2 clinical trial, a total of 60 moderate to severe migraine attacks in patients with an established diagnosis of migraine without aura who seek medical care within 72 hours of symptoms onset were administered either single dose 400 mg intravenous valproate diluted in 1oo cc Normal Saline or 10 mg intramuscular metoclopramide followed 10 minutes later by 6 mg subcutaneous Sumatriptan. Exclusion criteria include occurrence serious adverse effects any time during drug administration. Headache severity will be assessed by visual analog scale before treatment, and after 2, 4, and 24 hours of treatment. Potential complications also will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104096154N1
Registration date:2011-06-07, 1390/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-07, 1390/03/17
Registrant information
Name
Babak Bakhshayesh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1776 1031
Email address
bakhshayesh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan university of medical science,Vice chancellor for research
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical trial of comparison between intravenous sodium valproate and subcutaneous sumatriptan with intramuscular metoclopramide for treatment of acute attacks in patients with migraine headaches
Public title
comparison of intravenous sodium valproate versus subcutaneous sumatriptan and intramuscular metoclopramide for treatment of acute migraine attacks
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria include :fulfilling international headache society criteria for migraine without aura; absence of cardiovascular disease; absence of cerebrovascular disease; absence of drug allergy; absence of pregnancy; age between 16 to70 year-old.
Exclusion criteria include :occurrence of serious adverse drug effects at any time during drug administration.
Age
From 16 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan university of medical sciene
Street address
across Alzahra hospital, Namjoo street, Siadati street -
City
Rasht
Postal code
4144665385
Approval date
2011-01-29, 1389/11/09
Ethics committee reference number
12414
Health conditions studied
1
Description of health condition studied
migraine without aura
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
headache severity
Timepoint
before treatment,after 2, 4 , and 24 hours
Method of measurement
visual analog scale
Secondary outcomes
1
Description
side effects profile
Timepoint
before treatment ,after 2 , 4, and 24 hours
Method of measurement
history taking and physical examination
Intervention groups
1
Description
Single dose 10 mg intramuscular Metoclopramide injection followed 10 minutes later by single dose 6 mg subcutaneous Sumatriptan injection
Category
Treatment - Drugs
2
Description
Sodium Valproate 400 mg single dose diluted in 100 cc Normal Saline infusion over 10 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poorsina hospital of Rasht
Full name of responsible person
Dr Hamidreza Hatamian
Street address
Poorsina hospital of Rasht - Neurology department
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Science, Vice chancellor for research
Full name of responsible person
Dr Abdolrasool Sobhani
Street address
Across Alzahra hospitalt, Siadati street, Namjoo street -
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Science, Vice chancellor for research
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
Poorsina hospital of Rasht, Guilan University of Medical Sciences
Full name of responsible person
Dr Hamidreza Hatamian
Position
Neurologist, Associate professor
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, Across Azodi stadium, Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 2444
Fax
Email
babak.bakh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Poorsina hospital, Guilan Uuniversity of Medical Science
Full name of responsible person
Dr Babak Bakhshayesh Eghbali
Position
Assistant professor, Neurologist
Other areas of specialty/work
Street address
Poorsina Hospital
City
Rasht
Postal code
Phone
+98 13 1322 2444
Fax
Email
bakhshayesh@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Poorsina hospital, Guilan university of medical science
Full name of responsible person
Dr Babak Bakhshayesh Eghbali
Position
Neurologist, Assistant professor
Other areas of specialty/work
Street address
Poorsina hospital
City
Rasht
Postal code
Phone
+98 13 1322 2444
Fax
Email
bakhshayesh@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)