Evaluating the effectiveness of Satinex buccal spray in improving quality of life in patients suffering multiple sclerosis
Design
Double blinded placebo controlled parallel group trial, randomised, phase 2 clinical trial on 60 patients, block randomisation carried out at "sealedenvelope.com" randomisation website
Settings and conduct
This research is going to be conducted on patients who meet inclusion criteria, they are randomly divided in two groups kept blind(patient and doctor don't know that who gets drug and who doesn't),follow up is done every week via telephone call and 2 times by doctor after the first visit
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Informed and written consent of all patients included in the study
Patients diagnosed with multiple sclerosis by a specialist
Stability of patients disease since one month prior to the study being started Patients Disease Modifying Therapy regimen should remain the same during the study
Adults of 18-65 years of age
Exclusion criteria:
A history of Schizophrenia and other serious mental morbidities (Except depression and anxiety due to MS disease)
A history of substance abuse Smoking and generally using cannabis
Taking Botulinum shot since 4 months prior to the study starting date
a history of serious diseases eg. epilepsy; Myocardial Infarction and heart attack and severe renal and hepatic failure
pregnancy and lactation
Taking other investigational drugs
Intervention groups
In this research
a group of patients are told to take Satinex spray prescribed by their doctor
while the placebo group will take a placebo instead (Which is made of ingredients similar to Satinex spray however it does NOT have any Active Pharmaceutical Ingredient in it)
Main outcome variables
Quality of life; Levels of pain; Levels of spasticity; Spasticity frequency; Levels of sleep disorders due to spasticity; Stage of disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046986N1
Registration date:2020-05-03, 1399/02/14
Registration timing:prospective
Last update:2020-05-03, 1399/02/14
Update count:0
Registration date
2020-05-03, 1399/02/14
Registrant information
Name
Saeed Shahbeigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7795 7666
Email address
s_shahbeigi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and effectiveness of Satinex buccal spray for improving quality of life in multiple sclerosis patients
Public title
Safety and effectiveness of Satinex buccal spray
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written Informed consent of all patients included in the study
Patients diagnosed with multiple sclerosis by a specialist
Stability of patients disease since one month before the study being started
Patients Disease Modifying Therapy regimen should remain the same during the study
Exclusion criteria:
A history of Schizophrenia and other serious mental morbidities (Except depression and anxiety due to MS disease)
A history of substance abuse
Smoking and generally using cannabis (since 30 days prior to the study starting date and disability to quit during the study ) and taking any other cannabis based medications (60 days prior to study starting date)
taking Botulinum shot since 4 months prior to the study starting date
a history of epilepsy and repetitive convulsions
a history of MI and serious cardiac arrest
acute liver and renal failure
pregnancy and lactation
Taking other investigational drugs
elective surgeries and blood donation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization method, randomized via "www.sealedenvelope.com" application; blind allocation (concealed allocation type) which means that the person allocating the participant to a group is blinded to which group (treament or control) they are allocating them to.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patient taking drug, and the doctor who diagnoses the patients and measures outcomes, is kept blind while the researcher who analyzes the outcomes is completely aware of the circumstances
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad univesity of Medical Science
Street address
No 16, Azad university of medical science institutional block, western Goleyakh alley, Ayeneh Blvd., Pabarja Ave., Shariati St.
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2019-11-20, 1398/08/29
Ethics committee reference number
IR.IAU.TMU.REC.1398.157
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
quality of life
Timepoint
Filling the MSQOL questionnaire prior to the intervention, At the end of the first, second and third month since the starting point
Method of measurement
MSQOL-54 questionnaire
2
Description
levels of spasticity
Timepoint
At the starting point and at the end of the third month of the research
Method of measurement
Modified Ashworth Scale for grading spasticity
3
Description
levels of pain
Timepoint
At the starting point and at the end of every week from the starting point
Method of measurement
Numerical Rating Scale
4
Description
Spasticity frequency (times per day)
Timepoint
At the starting point and at the end of every week from the starting point
Method of measurement
Visual Analogue Scale
5
Description
levels of sleep disorder due to spasticity
Timepoint
At the starting point and at the end of every week from the starting point
Method of measurement
Visual Analogue Scale
6
Description
disease stage
Timepoint
At the starting point and at the end of the third month of the research
Method of measurement
Expanded Disability Status Scale (EDSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Satinex spray ,chemical ingredients: delta-9-tetrahydrocannabinol or THC (2.7 milligrams in each single 100 microliter) Cannabidiol or CBD (2.5 milligram in each single 100 microliter spray , other ingredients (as exepients : ethanol, propylene glycol, peppermint), Manufacturer: YASDAROU company, route of administration: buccal spray
Category
Treatment - Drugs
2
Description
Control group: Placebo spray (containing every ingredient in Satinex but API : ethanol, propylene glycol, peppermint oil)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shahbeigi neurology clinic
Full name of responsible person
Saeed Shahbeigi
Street address
No 24, Komijani Ave., Hafthowz Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1648894833
Phone
+98 21 7795 7666
Email
s-shahbeigi@yahoo.com
Web page address
http://tazeha.org/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasdaru pharmaceuticals
Full name of responsible person
Gholamreza Amin
Street address
No 8, Hamedan ALY., Northern Karegar St., across from Laleh park, Teharn, Iran
City
Tehran
Province
Tehran
Postal code
1418693883
Phone
+98 21 6657 7724
Email
gh_amin@yahoo.com
Web page address
http://new.yasdaru.co.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?