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Amantadine and dalfampiridine effects on multiple sclerosis

Comparison of amantadine and dalfampridine efficacy in multiple sclerosis patients with fatigue

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190804044429N2
Enrollment
80
Registered
2020-06-12
Start date
2020-06-09
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Intervention group: dalfampridine 10 m q12 hour for 8 weeks. Intervention 2: Control group: Amantadine 100 mg q 12 hour for 8 weeks.

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients were aged more than 18 years Patients with multiple sclerosis according to Mcdonald criteria 2017 and EDSS less than 5.5 MS patients with at least fatigue score of 33 according to MFIS

Exclusion criteria

Exclusion criteria: Severe depression Hypothyroidism Severe anemia ( Hb‹ 9 g/dl) Pregnancy or breast feeding Ischemic heart disease or cardiovascular disease Renal insufficiency MS exacerbation within 30 days before Uncontrolled blood pressure (BP more than 160/100 mm Hg) use of other effective treatment on fatigue Alcohol, recreational and substance abuse history Monoamine oxidase inhibitors (MAOIs) use Narcolepsy history Psychosis history Seizure history

Design outcomes

Primary

MeasureTime frame
Fatigue improvement. Timepoint: At weeks 4, and 8. Method of measurement: MFIS questionnaire.

Secondary

MeasureTime frame
Quality of life. Timepoint: At weeks 4 , 8. Method of measurement: SF-36 Questionnaire.;Tolerable of therapeutic regimen. Timepoint: Weekly. Method of measurement: History taking.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Ghazaeian

Mazandaran University of Medical Sciences

ghazaeianm@gmail.com+98 11 3334 3011

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026