Evaluation of the effectiveness of liposomal cannabidiol on the improvement of motor symptoms in patients with generalized and focal dystonia compared with placebo
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. stratified randomized ,phase 3 on 60 patients
Settings and conduct
At the Neurology Clinic, after selecting patients, the intervention is performed for 9 weeks.
Before receiving the intervention and then at the end of the third, sixth and ninth week of the intervention, the severity of motor symptoms,It is measured by a researcher who is blind to the type of intervention, based on the corresponding movement scales in two groups.
The intervention is then discontinued for 5 weeks.At the beginning of the second period, the crossover is performed and the control and intervention groups are changed.The measurements will be performed in the same way as the first period.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of generalized or focal dystonia based on clinical signs
Age over 18 years
Lack of complete control of dystonia symptoms with drug therapy
Exclusion criteria:
There is any evidence that dystonia is secondary
Recent stroke or heart attack
High blood pressure
Cognitive impairment
Recorded history of psychiatric disorders
History or current substance abuse
Current use of anticoagulants
History of liver disease
Pregnancy or intent to conceive or breastfeed
History of dystonic surgery
Sensitivity to soy
Intervention groups
Intervention:Liposomal cannabidiol oil at a dose of 10 mg every 6 hours for 9 weeks, starting at a dose of 10 mg every 12 hours and increasing to the target dose within 5 days
Placebo:similar to the intervention group
Main outcome variables
Severity of dystonic motor symptoms, Van Marsden Scale and Global Dystonia Scale,TWSTRS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211019052811N1
Registration date:2021-11-27, 1400/09/06
Registration timing:registered_while_recruiting
Last update:2021-11-27, 1400/09/06
Update count:0
Registration date
2021-11-27, 1400/09/06
Registrant information
Name
zeinab ameli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 6778
Email address
ameliz981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of cannabidiol in the treatment of adult dystonias-a randomized placebo-controlled clinical trial
Public title
Evaluation of the effect of cannabidiol in the treatment of dystonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with focal-generalized dystonia
Failure to improve the patient's dystonic symptoms with previous drug treatments
Exclusion criteria:
Evidence that dystonia is secondary to other diseases
History of liver disease
Pregnancy or intent to conceive or breastfeed
History of dystonic surgery, including deep brain stimulation and destructive surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients in two groups is done using stratified randomization method. Due to the existence of two types of dystonia, we perform the block randomization method within each class. For this purpose, within each class, blocks with size a, b) aabb, abab, abba, baba, bbaa, baab) are randomly selected and patients Will be assigned to treatments according to this random sequence.To match the manual intensity in the treatment groups, for each intensity, a random sequence is created by blocking method with size 2 or 4, and the patients are assigned to the treatment group based on the obtained sequence.We use the tool for block randomization using the sealed envelope site
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients receiving cannabidiol and placebo are blind to receiving the drug and the severity of motor symptoms is assessed by the researcher in relation to the type of blind intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
َAhmad Abad Ave,Hospital Ghaem
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Approval date
2021-10-19, 1400/07/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.461
Health conditions studied
1
Description of health condition studied
dystonia
ICD-10 code
G24
ICD-10 code description
Dystonia
Primary outcomes
1
Description
Intensity of dystonia motion symptoms based on Van Marsden Scale and Global Dystonia Scale and TWSTRS
Timepoint
Before the intervention (0), then 3, 6, and 9 weeks after the start of the intervention or placebo
Method of measurement
Van Marsden Scale and Global Dystonia Scale and TWSTRS
Secondary outcomes
1
Description
Quality of life using SF-36 questionnaire
Timepoint
Before the intervention (0), then 3, 6, and 9 weeks after the start of the intervention or placebo
Method of measurement
SF-36 questionnaire
Intervention groups
1
Description
Intervention group:Liposomal cannabidiol drops are given at a dose of 10 mg every 6 hours. The drug is started with a dose of 10 mg every 12 hours (2 ml) and after 5 days is increased to a dose of 10 mg every 6 hours. Due to the divided dose of the drug, the patient will be more tolerant of the dose of the drug.The patient's previous treatments are reviewed and kept constant from one month before the end of the study.Patients receive the intervention for 9 weeks. Once before receiving the intervention and then at the end of the third, sixth and ninth week of the intervention, the severity of motor symptoms is measured by the researcher, who is blind to the type of intervention, based on the relevant movement scales in both groups.After the first period, it will be August 5 for 5 weeks and the intervention will be stopped in both groups. At the beginning of the second period, crossover is performed and patients who received the main drug in the first period will be assigned to the placebo group and those who received the placebo first will be assigned to the main drug group. The measurements will be performed in the same way as the first period.
Category
Treatment - Drugs
2
Description
Control group:Pharmacopoeia receive exactly the same drug as the main drug in the form of drops with the same color and taste as the main drug.Then, as in the intervention group, other actions are performed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital Clinic
Full name of responsible person
Zeinab Ameli
Street address
Ahmad Abad Ave,Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766991999
Phone
+98 51 3859 6778
Email
zameli_2010@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour
Street address
Daneshgah Ave,Ghoreyshi building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Olfati Nahid
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Ahmad Abad Ave,Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3859 6778
Email
olfatin@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Olfati
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Ahmad Abad Ave,Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
olfatin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zeinab Ameli
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ahmad Abad Ave,Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
zameli-2010@yahoo.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
There is no more information
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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available