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The effect of amantadine on cognitive dysfunction and quality of life in adults with traumatic brain injury.

Investigating the effectiveness of amantadine in improving cognitive dysfunction and improving quality of life in adults with moderate traumatic brain injur

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151123025202N50
Enrollment
90
Registered
2026-01-04
Start date
2026-01-21
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Traumatic brain injury. Diffuse traumatic brain injury with loss of consciousness of 30 minutes or less, initial encounter

Interventions

Intervention 1: Intervention group: In addition to routine treatment for traumatic brain injury, they will receive amantadine 200 mg twice daily (oral or via a feeding tube) for 8 weeks. Intervention

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with acute brain injury Glasgow Coma Scale score of 9 to 12 in the first 24 hours of injury Having post-traumatic amnesia and immediately after the accident Having at least mild diffuse axonal damage Age 18 to 75 years

Exclusion criteria

Exclusion criteria: People with a history of underlying cognitive and memory impairment Any central nervous system-related disability that existed before the traumatic brain injury Pregnant women Serious kidney disease (estimated creatinine clearance less than 60 ml/min), Patient with a history of more than one seizure in the previous month History of previous treatment with amantadine and sensitivity to amantadine

Design outcomes

Primary

MeasureTime frame
Changes in cognitive function in the two domains of return to life and ability to take care of oneself. Timepoint: Before treatment and 8 weeks after treatment. Method of measurement: Dementia Rating Scale (DRS).

Secondary

MeasureTime frame
Possible side effects of amantadine treatment. Timepoint: From the beginning of treatment to the end of treatment. Method of measurement: Clinical examination and telephone follow-up.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbbas Moradi

Hamedan University of Medical Sciences

a.moradi@umsha.ac.ir+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026