IRCT20210707051810N2
Recruiting
Phase 3
Evaluation of the effect of Levetiracetam on cognitive impairment in patients with relapsing- remitting multiple sclerosis (RRMS) based on minimal assessment of cognitive function in multiple sclerosis (MACFIMS)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 88
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with relapsing\-remitting multiplesclerosis age between 18 and 60 years
- •Have a minimum education to perform cognitive tests
- •RRMS (2017 Revisions of the McDonald” Criteria )
- •At least 2 years have passed since the definitive diagnosis of the disease
- •Receiving first\-line injectable and oral disease modifying drugs (interferon beta, glatiramer acetate, triflunomide and dimethyl fumarate)
- •Type and dose of DMD have not changed in the last six months
- •Have not received corticosteroids in last 30 days
- •Have not relapse in the last 60 days
- •Expanded Disability Status Scale (EDSS) scores of 5\.5 or less
- •Voluntarily participated in the present study
Exclusion Criteria
- •History of drug or alcohol abuse in the last six months
- •Pregnancy and lactation
- •Having any acute or major mental disorder that is not under control (type of medication and amount of use in the last three months is constant)
- •Having any seizure disorder
- •History of any suicide attempt
- •Chronic kidney disease (Estimated glomerular filtration rate less than 60 ml / min)
- •Diabetes, hypothyroidism and anemia that is not under control
- •Concomitant use of drugs that may affect cognitive function, such as antipsychotics, modafinil, methylphenidate, amphetamine and amphetamine\-like compounds, tricyclic antidepressants and anticonvulsants other than gabapentin and pregabalin, benzodiazepines other than as sleeping pills Avar (if the dose and method of medication do not change in the last three months and during the study will not be prohibited).
Outcomes
Primary Outcomes
Not specified
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