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Clinical Trials/IRCT20210707051810N2
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)

Tehran University of Medical Sciences0 sites88 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

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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