Evaluating the effect of Fampridine on
- cognitive function
- gait function
- upper limb function
- walking disability self-rating
- Expanded Disability Status Scale (EDSS)
in Multiple Sclerosis patients
Evaluating the relationship of EDSS score with response to Fampridine
Evaluating the relationship of age and sex with response to Fampridine
Design
Phase III double-blinded placebo-controlled randomized trial of 108 patients enrolled between January 2024 and January 2025.
Settings and conduct
Patients are assessed by a neurologist or General practitioner in two hospital MS clinics in Tehran(Imam Khomeini and Imam Hussein hospital) and appropriate tests will be conducted. Patients, their caregivers, interviewer and medical personnel who are involved in the study are all blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: age between 18-60 years, definite Multiple sclerosis diagnosis based on 2017 McDonald criteria, SDMT score below the 20th percentile based on normative values, ability to perform motor tests without help of a person
Exclusion criteria are: History of relapse within 2 months of first visit and during the study; History of seizure; History of Fampridine use within 1 month of first visit; moderate or higher renal dysfunction (GFR lower than 50 mL/min)
Intervention groups
Eligible patients receive appropriate instructions and give permission and consent to enroll in the study. They will be assessed in person at commencement and also after 12 weeks of getting placebo or Fampridine. During each visit, questionnaires and functional tests - cognitive and physical domains - will be completed accordingly. During the study patients will be contacted regularly and will be asked about drug side effects and their drug adherence.
Main outcome variables
Change in SDMT test score after 12 weeks of intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161212031362N4
Registration date:2024-05-10, 1403/02/21
Registration timing:prospective
Last update:2024-05-10, 1403/02/21
Update count:0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Mohammad Hossein Harirchian
Name of organization / entity
Iranian center of neurological research
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 8899
Email address
harirchm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-19, 1403/02/30
Expected recruitment end date
2025-01-09, 1403/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of Fampridine on cognitive outcome measures in multiple sclerosis patients: A double-blind, randomized, placebo-controlled study
Public title
Evaluating the short-term effect of Fampridine on cognitive function in Multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite MS diagnosis according to McDonald 2017 criteria
Age between 18-60 years
SDMT score below the 20th percentile of normative values
Exclusion criteria:
History of relapse within 2 months
History of seizure/epilepsy
History of major depression or psychosis
Reluctance to enroll in the study
Moderate or higher renal dysfunction (eGFR=< 50mL/min/1.73m2)
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the study is achieved by block randomization of patients in to blocks of 12 (6 in Fampridine group and 6 in Placebo group) by Web-based Randomization. each space in any given block is given a code consisting of 3 random digits or letters (fk8 for example). These codes are written on the drug labels as well and are given to patients enrolled in the study. The study coordinators will use a list containing the order of these codes, and according to this list and in sequence of entry into the study, they will deliver the vial to the participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants and other health care providers, including medical staff involved in the study, are blinded to the allocation of patients into either the Fampridine or placebo group. Medications and placebos are administered to patients by a clinical observer who remains unaware of the contents of the medication vials.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Neuroscience Institute , Tehran University of Medical Sciences
Street address
Neuroscience Institute, Imam Khomeini Hospital complex; Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2023-12-16, 1402/09/25
Ethics committee reference number
IR.TUMS.NI.REC.1402.041
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
Change in (SDMT) Symbol Digit Modalities Test score (improvement of equal or greater than 4 points or more than 20% increase compared to baseline score is considered a meaningful change)
Timepoint
First visit (baseline) and 12 weeks after intervention
Method of measurement
SDMT test which is scored based on the number of correct answers in 90 seconds
Secondary outcomes
1
Description
Change in California Verbal Learning Test (CVLT) test score
Timepoint
First visit (baseline) and 12 weeks after intervention
Method of measurement
CVLT test
2
Description
Change in Brief Visuospatial Memory Test (BVMT) test score
Timepoint
First visit (baseline) and 12 weeks after intervention
Method of measurement
BVMT test is performed three times consecutively and the sum of three scores is considered as total BVMT score
3
Description
Change in Twelve Item MS Walking Scale (MSWS-12) test score
Timepoint
First visit (baseline) and 12 weeks after intervention
Method of measurement
MSWS-12 questionnaire
4
Description
Timed 25-Foot Walk (T25-FW) test score improvement
Timepoint
First visit (baseline) and 12 weeks after intervention
Method of measurement
Timed 25-Foot Walk (T25-FW)
5
Description
Improvement in 9-Hole Peg Test (9-HPT) score
Timepoint
First visit (baseline) and 12 weeks after intervention
Method of measurement
9-Hole Peg Test (9-HPT) is performed twice for each hand and mean of 4 tests is considered total score
6
Description
Modified Fatigue Impact Scale (MFIS) score change
Timepoint
First visit (baseline) and 12 weeks after intervention
Change in Insomnia Severity Index (ISI) questionnaire score
Timepoint
First visit (baseline) and 12 weeks after intervention
Method of measurement
Insomnia Severity Index (ISI) questionnaire
8
Description
Change in Hospital Anxiety and Depression Scale (HADS) score
Timepoint
First visit (baseline) and 12 weeks after intervention
Method of measurement
Hospital Anxiety and Depression Scale (HADS) questionnaire
Intervention groups
1
Description
Control group: Patients are given Placebo tablet for 12 weeks which is identical in shape and other physical characteristics as well as packaging. Drugs are instructed to be used every 12 hours, similar to the intervention group. Patients are instructed to take the tablet without food, on an empty stomach
Category
Placebo
2
Description
Intervention group: Patients are given Fampridine 10mg (Dalphyra, Cinnagen) for 12 weeks (instructed to be taken every 12 hours one in the morning and one in the afternoon). Patients are instructed to take the tablet without food, on an empty stomach.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital MS clinic
Full name of responsible person
Sadra Habibi Moini
Street address
MS clinic, Imam Khomeini Hospital, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Hussein hospital MS clinic
Full name of responsible person
Sadra Habibi Moini
Street address
Madani Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian Center of Neurological Research
Full name of responsible person
Prof. Mohammad Hossein Harirchian
Street address
Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 6658 1560
Email
harirchm@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian Center of Neurological Research
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
Tehran University of Medical Sciences
Full name of responsible person
Sadra Hbibi Moini
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
9, Ladan Aly, Valiasr St
City
Tehran
Province
Tehran
Postal code
1961713635
Phone
+98 21 2270 7188
Email
sadrahabibi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Hossein Harirchian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Imam Khomeini hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6694 8899
Fax
+98 21 6658 1558
Email
harirchm@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadra Habibi Moini
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
9, Ladan St, Valiasr St
City
Tehran
Province
Tehran
Postal code
1961713635
Phone
+98 21 2270 7188
Email
sadrahabibi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
There is no further information
When the data will become available and for how long
The access period begins 6 months after publication of results.
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
Email address: harirchm@sina.tums.ac.ir
What processes are involved for a request to access data/document