Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592352
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-03
Brief Title:
MODAFIMS A Trial to Evaluate Predictors of Response to MODAFinil in Patients With Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MODAFIMS An Open-label Single-center Clinical Trial to Evaluate Predictors of Response to MODAFinil in the Treatment of Cognitive Deficits in Patients With Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MODAFIMS
Brief Summary:
This is a phase IIexploratory clinical trial with a single-center open-label design to evaluate the effect of modafinil on cognitive deficits in adult patients with multiple sclerosis and identify predictors of response using functional Magnetic Resonance Imaging fMRI
Detailed Description:
Multiple sclerosis MS is a neurodegenerative disease that affects the central nervous system There are no commercially authorized therapeutic options available for the treatment of cognitive impairment in patients with multiple sclerosis It is then necessary to conduct robust clinical trials to select better therapies
Modafinil is a drug approved by INFARMED and European Medicines Agency EMA for the treatment of excessive sleepiness associated with narcolepsy Modafinil has been tested in 5 clinical trials in patients with multiple sclerosis and the results indicated a potential improvement in cognitive deficits in tasks that measure executive function verbal memory andor working memory performance
Despite encouraging results there is a huge variation in its effect in individual patients and a significant proportion of sub-optimalnon-responders Therefore it is important to identify personalized predictors of response to best tailor the treatment to each patient
This is a phase IIexploratory clinical trial with a single-center open-label design to evaluate the effect of modafinil on cognitive deficits in adult patients with multiple sclerosis and identify predictors of response using functional Magnetic Resonance Imaging fMRI
The primary objective of the clinical trial is to identify fMRI markers of response to modafinil In other words our aim is to analyse brain activity using fMRI before and after modafinil intake and select the features that can better differentiate between responders and non-responders These patient groups will be determined according to the improvement rate in the Symbol digit modalities test SDMT - which will be evaluated at screening baseline and at the end of treatment
The clinical trial will be conducted at Centro Clínico Académico - Braga Associação 2CA-Braga Unidade Local de Saúde de Braga ULS Braga EPE Participants will be recruited at the outpatient unit of the Neurology department of ULS de Braga
A total of 64 eligible patients will be enrolled to receive modafinil at a dose 200 mg 2 tablets of 100 mg once per day in the morning for 3 months
Modafinil is a drug approved by INFARMED and European Medicines Agency EMA for the treatment of excessive sleepiness associated with narcolepsy Modafinil has been tested in 5 clinical trials in patients with multiple sclerosis and the results indicated a potential improvement in cognitive deficits in tasks that measure executive function verbal memory andor working memory performance
Despite encouraging results there is a huge variation in its effect in individual patients and a significant proportion of sub-optimalnon-responders Therefore it is important to identify personalized predictors of response to best tailor the treatment to each patient
This is a phase IIexploratory clinical trial with a single-center open-label design to evaluate the effect of modafinil on cognitive deficits in adult patients with multiple sclerosis and identify predictors of response using functional Magnetic Resonance Imaging fMRI
The primary objective of the clinical trial is to identify fMRI markers of response to modafinil In other words our aim is to analyse brain activity using fMRI before and after modafinil intake and select the features that can better differentiate between responders and non-responders These patient groups will be determined according to the improvement rate in the Symbol digit modalities test SDMT - which will be evaluated at screening baseline and at the end of treatment
The clinical trial will be conducted at Centro Clínico Académico - Braga Associação 2CA-Braga Unidade Local de Saúde de Braga ULS Braga EPE Participants will be recruited at the outpatient unit of the Neurology department of ULS de Braga
A total of 64 eligible patients will be enrolled to receive modafinil at a dose 200 mg 2 tablets of 100 mg once per day in the morning for 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None