The objective of this study is to compare the efficacy of the new anti-epileptic drug lacosamide when compared with conventional treatment with topiramate for the treatment of young adults with chronic migraine
Design
Quasi experimental interventional study
Settings and conduct
Double blinded with the doctor and patient unaware of the study protocol with the doctor advising the interventional drug to the patient in sealed envelopes from the department
Participants/Inclusion and exclusion criteria
All male and female patients aged 18-30 diagnosed with migraine according to the ICHD 3 criteria and having chronic migraine will be included
Patients with diabetes and hypertension or critical respiratory, renal or cardiac disease, patients with allergy to lacosamide or topiramate and patients unwilling to be included in the study will be excluded
Intervention groups
Two Groups
Group L receiving Oral Lacosamide 150 mg twice a day
Group T recieving Oral Topiramate 50 mg twice a day
Main outcome variables
Frequency of acute attacks in the following three months of therapy and improvement seen by standard Chronic headache quality of life questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230809059091N1
Registration date:2023-08-09, 1402/05/18
Registration timing:registered_while_recruiting
Last update:2023-08-09, 1402/05/18
Update count:0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
Nabeel Butt
Name of organization / entity
Combined Military Hospital Rahim Yar Khan
Country
Pakistan
Phone
+92 313 5969696
Email address
nabeel4allz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-09, 1402/05/18
Expected recruitment end date
2023-11-09, 1402/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARISON OF EFFICACY OF ORAL LACOSAMIDE VERSUS ORAL TOPIRAMATE IN YOUNG ADULTS WITH CHRONIC MIGRAINE
Public title
ORAL LACOSAMIDE AND ORAL TOPIRAMATE IN PREVENTING MIGRAINE ATTACKS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ALL PATIENTS AGED 18-30 YEARS DIAGNOSED WITH MIGRAINE ACCORDING TO THE ICHD 3 CRITERIA
PATIENTS WITH CHRONIC MIGRAINE AS HEADACHE OCCURRING ON 15 OR MORE DAYS PER MONTH FOR MORE THAN THREE MONTHS, WHERE AT LEAST 8 OF THOSE HEADACHE DAYS HAVE MIGRAINE FEATURES
Exclusion criteria:
PATIENTS WITH KNOWN HYPERTENSION, DIABETES OR ADVANCED CARDIAC OR RESPIRATORY DISEASE
PATIENTS WITH ALLERGY TO EITHER LACOSAMIDE OR TOPIRAMATE
PATIENTS WITH AN ACUTE EPISODE OF MIGRAINE IN THE LAST ONE WEEK
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
METHOD OF SAMPLING BETWEEN BOTH GROUPS WAS NON-PROBABILITY CONSECUTIVE SAMPLING BY LOTTERY METHOD
Blinding (investigator's opinion)
Double blinded
Blinding description
SEALED ENVELOPES WITH MEDICATIONS MARKED A AND B GIVEN TO THE PATIENTS WITH NEITHER THE DOCTOR OR THE PATIENT KNOWING WHICH ENVELOPED CONTAINED WHICH DRUG
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical review board CMH RYK
Street address
Chowk Bahadarpur
City
Rahim Yar Khan
Postal code
64200
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
00100
Health conditions studied
1
Description of health condition studied
Chronic migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Frequency of migraine attacks and improvement in quality of life
Timepoint
Three months post-intervention
Method of measurement
Standardized Chronic headache quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group L (Oral Lacosamide)
Category
Treatment - Drugs
2
Description
Intervention group: Group T (Oral Topiramate)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital Rahim Yar Khan
Full name of responsible person
Dr. Nabeel Tahir Butt
Street address
Chowk Bahadarpur
City
Rahim Yar Khan
Postal code
64200
Phone
+92 313 5969696
Email
nabeel4allz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Rahim Yar Khan
Full name of responsible person
Dr. Nabeel Tahir Butt
Street address
Chowk Bhadarpur
City
Rahim Yar Khan
Postal code
64200
Phone
+92 313 5969696
Email
nabeel4allz@gmail.com
Grant name
None
Grant code / Reference number
None
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital Rahim Yar Khan
Full name of responsible person
Dr. Nabeel Tahir Butt
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Chowk Bhadarpur
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
+92 313 5969696
Email
nabeel4allz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Rahim Yar Khan
Full name of responsible person
Dr. Nabeel Tahir Butt
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Chowk Bahadarpur
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
+92 313 5969696
Email
nabeel4allz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
CMH Rahim Yar Khan
Full name of responsible person
Dr. Nabeel Tahir Butt
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Chowk Bhadarpur
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
+92 313 5969696
Email
nabeel4allz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Will only be shared after study peer reviewed and published after approval by the journal
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Available in the text of the article
When the data will become available and for how long
Will be available indefinitely after approval by the journal
To whom data/document is available
Everyone having access to article text
Under which criteria data/document could be used
None
From where data/document is obtainable
Via email provided
What processes are involved for a request to access data/document