Determining the effect of Fampridine (4-aminopyridine) on motor and non-motor symptoms of Parkinson's disease in patients referred to the neurology clinic.
Design
Clinical trial with intervention and control group, with parallel groups, double-blind, randomized, phase 3 on 62 patients.
For randomization, block random assignment and the order of assigning each person to each group in a sealed envelope was used.
Settings and conduct
The study will be conducted on Parkinson patients referred to Shahr-e-Kord Neurology Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: known Parkinson's patient (based on symptoms and previous investigations); the presence of Parkinson's symptoms in the patient; the symptoms are not caused by other diseases (such as stroke, trauma, etc.); no interaction with other drugs; no history of seizures.
Exit criteria: unwillingness to cooperate; intervention drug interaction with usual drugs; occurrence of drug side effects; intensification of the patient's symptoms; death of the patient history or occurrence of seizures.
Intervention groups
One group will receive Fampridine tablets (Cinagen Pharmaceutical Company) as the intervention group, and the other group will receive placebo as the control group, and both groups will receive their standard treatment.
Main outcome variables
tremor condition; Brady Kinsey's situation; the state of rigidity; sleep disorder condition; Depressive state; state of anxiety; sexual disorder status; sphincter disorder condition; paresthesia condition of organs; Hypotension orthostatic state; General condition of motor and non-motor disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230905059361N1
Registration date:2023-10-03, 1402/07/11
Registration timing:registered_while_recruiting
Last update:2023-10-03, 1402/07/11
Update count:0
Registration date
2023-10-03, 1402/07/11
Registrant information
Name
Mohammad Shams
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3257 9932
Email address
mohammadsh3428@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2023-10-21, 1402/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Fampridine (4-aminopyridine) on motor and non-motor symptoms of Parkinson: A randomized double blind trial
Public title
Fampridine effect on Parkinson disease symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Known Parkinson's disease
presence of Parkinson's symptoms in the patient
The symptoms are not due to other diseases (such as stroke, trauma, etc.)
No interaction with other drugs
No history of seizures
Exclusion criteria:
Reluctance to cooperate
Interference of the intervention drug with usual drugs
Aggravation of the patient's symptoms
History or occurrence of seizures
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
In order to start the clinical trial study, with the coordination of the supervisor, 62 patients will be randomly selected from among the patients who meet the entry criteria referring to the neurology clinic, according to the sample size if they meet the entry criteria. Then, people will be assigned to two equal intervention and control groups using the random block allocation method with blocks of 2, 4, and 6, and the order of assigning each person to each group is placed in a sealed envelope based on blocks with a random number. The same number of people are assigned to each of the studied groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants do not know whether they are part of the intervention or control group and do not know whether they are taking medicine or placebo.
Medicines and placebos are given to patients by clinical caregivers, and the researcher does not know who received medicine or placebos
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahr-e-Kord University of Medical Sciences
Street address
Rahmatieh
City
Shahr-e-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8841646176
Approval date
2023-08-13, 1402/05/22
Ethics committee reference number
IR.SKUMS.MED.REC.1402.038
Health conditions studied
1
Description of health condition studied
Parkinson disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Motor and non-motor symptoms of Parkinson's disease
Timepoint
Before and after the start of the intervention
Method of measurement
Using the MDS-UPDRS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One group will receive fampridine tablets (Cinagen Pharmaceutical Company) as the intervention group. The new drug will be part of their treatment regimen along with the routine treatment regimen and the new treatment regimen will continue as before. The intervention group will receive fampridine tablets with a dose of 10 mg twice a day (Cinagen Pharmaceutical Company) for one month, which is currently considered as the duration of the study.
Category
Treatment - Drugs
2
Description
Control group: A group with the same size as the intervention group that receives placebo in the same amount and duration as the intervention group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Mohammad Shams
Street address
Shariati Street
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8841646176
Phone
+98 38 3224 2696
Email
Mohammadsh3428@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Arsalan Khaledifar
Street address
Rahmatieh
City
Shahr-e-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8841646176
Phone
+98 38 3333 9940
Email
Mohammadsh3428@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammad Shams
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Rahmatieh
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8841646176
Phone
+98 38 3333 9940
Email
Mohammadsh3428@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nahid Jivad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Rahmatieh
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8841646176
Phone
+98 38 3333 9940
Email
jivad@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammad Shams
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Rahmatieh
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8841646176
Phone
+98 38 3333 9940
Email
Mohammadsh3428@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data of the study before and after the intervention are collected and published to check the results of the intervention
When the data will become available and for how long
The access period starts about 6 months after the publication of the study results
Doctors to use the results of the study in better treatment of the disease
Pharmacists for more effort in improving the quality of this drug
Professors and students to know more about the effect of this medicine
Manufacturing companies to invest in more and better drug production
From where data/document is obtainable
Mohammad Shams Hafshejani
Contact: +989136763428
Email: Mohammadsh3428@gmail.com
What processes are involved for a request to access data/document
After contacting the person with the required information and after confirming the validity of the applicant, the method of obtaining the required information will be announced to the applicant within a few days.