Investigating the effect of ondansetron on Levodopa-induced dyskinesia in patients with Parkinson's disease
Providing scientific evidence regarding the effectiveness of amantadine replacement therapy in controlling levodopa-induced dyskinesia in patients with Parkinson's disease
Design
Phase 3 randomized clinical trial with parallel groups, with a control group, double-blind, will be conducted on 32 patients. For randomization, 16 blocks will be selected using the random number table (blocks of 4) so that the sample size reaches 32 people.
Settings and conduct
The research setting includes the neurology clinic of Vali Asr Medical Training Center in Zanjan and the research community includes all people with levodopa induced dyskinesia who refer to the center. Individuals will be selected by the available method and then randomly assigned to the intervention group, Ondansetron, and the control group, placebo. In this study, doctor and patients will be blinded.
Participants/Inclusion and exclusion criteria
patients can participate in study:
People with Parkinson's Stage 3, 4 based on Hoehn and Yahr scale
Age over 18 years
Having dyskinesia caused by levodopa
Patient satisfaction
patients must not participate in study:
Allergy to ondansetron (rash, itching)
Concomitant use of apomorphine in patients in off episodes
pregnancy
breastfeeding
occurrence of any unpredictable complications
The patient's unwillingness to continue participating in study
Intervention groups
The intervention group will take ondansetron tablets 8 mg daily orally in the first week and then 12 mg daily (8 mg in the morning and 4 mg at night) from the second to the eighth week for two months and the control group will receive a placebo with the same prescription. Effects will be evaluated at weeks zero, four and eight.
Main outcome variables
levodopa induced dyskinesia 's severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190427043389N5
Registration date:2023-12-11, 1402/09/20
Registration timing:prospective
Last update:2023-12-11, 1402/09/20
Update count:0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Hamed Ghavimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 3635
Email address
ghavimih@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of ondansetron on Levodopa-induced dyskinesia in patients with parkinson's disease
Public title
Investigating the effect of ondansetron on Levodopa-induced dyskinesia in patients with parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with Parkinson's disease stages 3, and 4 based on Hoehn and Yahr scale
age over 18 years
patients with levodpa induced dyskinesia
Patient satisfaction
Exclusion criteria:
Allergy to ondansetron (rash, itching)
Concomitant use of apomorphine in patients with off episodes
pregnancy
breastfeeding
The patient's unwillingness for participation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible people will be selected from the usual referrals to the neurology clinic of Vali Asr Zanjan educational center by the available method and then will be allocated to two groups by random block method (blocks of 4). The first group will receive oral tablets of ondansetron and the second group will receive placebo. For this purpose, blocks of 4 will be selected using a table of random numbers in the size of 16 blocks so that the sample size reaches 32 people. Blocking will be done by a person not involved in sampling. Each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. Finally, the lids of the envelopes will be glued and placed inside a box. At the start of the intervention to identify the order of the participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people will be assigned to two groups by random block method (blocks of 4). Patients will be blinded in this study. One group will receive standard treatment along with ondansetron tablets, while the other group will receive standard treatment along with a placebo. Placebo tablets are very similar to ondansetron tablets in terms of color, shape and size, but do not contain the active drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Zanjan University of Medical Science
Street address
Jomhouri Street, Azadi Boulevard, University Headquarters, 1st floor, Deputy of Research and Technology, Zanjan University of Medical Science
City
Zanjan
Province
Zanjan
Postal code
451561391
Approval date
2023-10-31, 1402/08/09
Ethics committee reference number
IR.ZUMS.REC.1402.205
Health conditions studied
1
Description of health condition studied
levodopa-induced dyskinesia
ICD-10 code
G21.11
ICD-10 code description
Neuroleptic induced parkinsonism
Primary outcomes
1
Description
Levodopa induced dyskinesia score in Unified Dyskinesia Rating Scale questionnare
Timepoint
Before intervention, one and two months after starting intervention
Method of measurement
Unified Dyskinesia Rating Scale questionnare
Secondary outcomes
1
Description
Levodopa-induced dyskinesia 's severity
Timepoint
Before starting intervention, one and two months after starting intervention
Method of measurement
Unified Dyskinesia Rating Scale questionnare
Intervention groups
1
Description
Intervention group: will take ondansetron tablets in the form of 8 mg daily orally in the first week and then in the form of 12 mg daily (8 mg in the morning and 4 mg at night) from the second to the eighth week for two months.
Category
Treatment - Drugs
2
Description
Control group: will receive the placebo in the order of the first week, two in the morning, and then, from the second to the eighth week, two in the morning and one in the evening.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Neurology clinic
Full name of responsible person
Hamed Ghavimi
Street address
Sheikh fazlolah Nori Ave, Valiasr square
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3373 9011
Fax
+98 24 3373 9026
Email
valiasr@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Jomhouri Street, Azadi Boulevard, University Headquarters, 1st floor, Deputy of Research and Technology, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3347 3635
Fax
+98 24 3347 3639
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan University of Medical Science
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
Zanjan University of Medical Sciences
Full name of responsible person
Hamed Ghavimi
Position
academic member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Gavazang Road, next to ayatollah mousavi hospital, Faculty of Pharmacy, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
0098 24 334736354
Email
Hamed.ghavimi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Hamed Ghavimi
Position
academic member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Gavazang Road, Next to Ayatollah Mousavi Hospital, Faculty of Pharmacy, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3347 3635
Email
Hamed.ghavimi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sama Arjmandikia
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 33, North Shariati Ave, Baharestan Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5157667431
Phone
+98 41 3331 1281
Email
samaarjmandikia@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
3 months
To whom data/document is available
Researchers
Under which criteria data/document could be used
A person can access the data after requesting the person in the charge of the trial and checking her reliability.
From where data/document is obtainable
Central Library of Zanjan University of Medical Science
What processes are involved for a request to access data/document
A person can access the data after requesting the person in the charge of the trial and checking her reliability.