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Lacosamide efficasy and safety on pain in patients with multiple sclerosis: A randomized double_blind clinical trial

Protocol summary

Study aim
Lacosamide efficacy and safety on pain in patients with multiple sclerosis : A randomized double-blind clinical trial
Design
Based on the randomization table (permuted block method in blocks of 4), patients are candidates to receive lacosamide or placebo for 12 weeks. All patients included in the study, who are 56 and placed in parallel groups, will receive a standard treatment regimen.
Settings and conduct
Patients with MS referred to the MS clinic of Bo Ali Sina Educational Center who meet the inclusion criteria and do not have the exclusion criteria are included in the study and are divided into two groups according to the randomization table and are evaluated for 12 weeks. The treating doctor, the patient and the evaluator are unaware of the type of therapeutic intervention.
Participants/Inclusion and exclusion criteria
Adults over 18 years of age and suffering from MS with moderate to high MS pain complaints are included in the study. Pregnant and lactating women, people with severe depression or suicidal thoughts, thyroid disorders, severe anemia, cerebral ischemia or cardiovascular disease, kidney failure, MS attack and corticosteroid pulse within the last month, drug abuse, psychotropic substances and alcohol , liver failure, cardiac arrhythmia or simultaneous use of drugs affecting heart rhythm and drugs affecting pain control,structural disorders affecting pain are excluded from the study.
Intervention groups
lacosamide 100 mg BD for the first week then 150 mg BD for second week after that 200 mg BD
Main outcome variables
Determining the effectiveness of lacosamide in reducing the intensity of pain caused by MS in patients with BPI and NPSI scales. Determining the overall improvement rate of MS patients after taking lacosamide based on (PGIC). Determining the improvement of function and quality of life of patients with MS after taking lacosamide based on (SF_36)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190804044429N8
Registration date: 2022-09-04, 1401/06/13
Registration timing: prospective

Last update: 2022-09-04, 1401/06/13
Update count: 0
Registration date
2022-09-04, 1401/06/13
Registrant information
Name
Monireh Ghazaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 6864
Email address
ghazaeianm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Lacosamide efficasy and safety on pain in patients with multiple sclerosis: A randomized double_blind clinical trial
Public title
Lacosamide efficasy and safety on pain in patients with multiple sclerosis: A randomized double_blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults over the age of 18 and suffering from MS with moderate to high MS pain complaint
Exclusion criteria:
Severe depression or suicidal thoughts Thyroid disorders Severe anemia (Hb<9g/dl) Breast feeding or pregnancy History of cerebral ischemia or cardiovascular disease Having kidney failure (creatinine clearance less than 30 ml/min) Existence of an MS attack during the past month Concomitant use of drugs effective in pain control during the last month History of abuse of drugs, psychotropic substances and alcohol History of liver failure History of cardiac arrhythmia or simultaneous use of drugs affecting heart rhythm Failure to receive corticosteroid pulse within a month before the starting of study Absence of a history of structural disorder affecting the occurrence of pain such as discopathy and other disease affecting the occurrence of neuropathic pain( diabetes, trigeminal neuralgia,...)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method will be used to allocate the samples to two groups. Blocks will be considered as 4 blocks and in each block of 4 people, two people in the intervention group and two people in the control group will be selected. The selection of the order type in each group for each person will be done through second version of random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double_ blind. Outcome elevator and participant are blinded (double blind) and aware from grouping (intervention or placebo)
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran university of medical Sciences
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari town
City
Sari
Province
Mazandaran
Postal code
4816864193
Approval date
2022-08-02, 1401/05/11
Ethics committee reference number
IR.MAZUMS.REC.1401.262

Health conditions studied

1

Description of health condition studied
Pain caused by MS
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Intensity of pain caused by MS
Timepoint
Weeks 0-4-8-12
Method of measurement
Brief pain index (BPI)

2

Description
Intensity of pain caused by MS
Timepoint
Weeks 0-4-8-12
Method of measurement
NPSI (Neuropathic Pain Symptom Inventory )

3

Description
The overall improvement rate of MS patients after taking lacosamide
Timepoint
Weeks 0-4-8-12
Method of measurement
Patient Global Impression of Change (PGIC).

4

Description
The safety of lacosamide in improving pain caused by MS.
Timepoint
Weekly
Method of measurement
Patient tolerability

Secondary outcomes

1

Description
Determining the improvement in function and quality of life of patients with MS following the use of lacosamide
Timepoint
Weeks 0-8-12
Method of measurement
Item Short Form Survey (SF-36)

Intervention groups

1

Description
Intervention group: Half of the patients in the lacosamide group received lacosamide tablets 100 mg twice a day in the first week, and from the second week, the dose was prescribed as 150 mg every 12 hours, and in the third week, 200 mg twice a day if tolerated. In weeks 0, 4, 8 and 12, they are visited by a neurologist.
Category
Treatment - Drugs

2

Description
Control group: Half of the patients in the control group receive a placebo in the form of tablets with the same color, size and packaging as the intervention group and without the active pharmaceutical ingredient every 12 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn Sina hospital
Full name of responsible person
Monireh Ghazaeian
Street address
Ibn Sina hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4800
Fax
+98 11 3335 2725
Email
Ghazaeianm@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Vice chancellor for Research, Mazandaran University of medical Sciences, Joybar 3way, Sari,Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4800
Fax
+98 11 3335 2725
Email
pebrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 33343011
Email
Ghazaeianm@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
Ghazaeianm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
Ghazaeianm@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to the initial outcoms of the study will be shared
When the data will become available and for how long
The data will be available one year after publication
To whom data/document is available
Academic reseachers, medical team and scientific institutes
Under which criteria data/document could be used
Requests for sharing data should be sent to the person responsible for general inquiries
From where data/document is obtainable
Requests for sharing data should be sent to the person responsible for general inquiries. Ghazaeianm@gmail.com
What processes are involved for a request to access data/document
Person in charge of scientific study will reply to the request within 10 days.
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