Evaluation of the effect of riluzole in improving the condition of patients with severe traumatic brain injury

Evaluation of Riluzole efficacy on cognitive and functional outcome of severe traumatic brain injury patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191104045328N6

Enrollment

Registered

2021-04-30

Start date

2021-05-05

Completion date

Unknown

Last updated

2021-05-26

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

Interventions

Intervention 1: Intervention group: The treatment protocol includes administration of the drug (riluzole) for 2 weeks, at a dose of 500 mg every 12 hours, preferably during the first 12 hours after tr

Eligibility

Sex/Gender

All

Age

16 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with severe traumatic brain injury Impenetrable brain injury Age over 16 years Ability to receive medication through the mouth or nasogastric tube Glasgow Coma Scale (GCS) less than 9 Having informed consent by family members primarily to participate in the study

Exclusion criteria

Exclusion criteria: Kidney and liver failure History of severe brain injury (tumor or stroke) Unidentifiable patients Pregnancy

Design outcomes

Primary

Measure	Time frame
Glasgow Coma Scale. Timepoint: Upon arrival of the patient, after initial resuscitation, third day, seventh day. Method of measurement: Glasgow Coma Scale Checklist.;4 score. Timepoint: Upon arrival of the patient, after initial resuscitation, third day, seventh day day. Method of measurement: 4 score checklist.;Glasgow outcome scale. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: glasgow outcome scale checklist.;Karnovsky performance status. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Karnovsky performance status checklist.;Mini Mental State Test. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Mini Mental State Test.;Disability Rating Scale. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Disability Rating Scale.	—

Measure

Time frame

Glasgow Coma Scale. Timepoint: Upon arrival of the patient, after initial resuscitation, third day, seventh day. Method of measurement: Glasgow Coma Scale Checklist.;4 score. Timepoint: Upon arrival of the patient, after initial resuscitation, third day, seventh day day. Method of measurement: 4 score checklist.;Glasgow outcome scale. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: glasgow outcome scale checklist.;Karnovsky performance status. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Karnovsky performance status checklist.;Mini Mental State Test. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Mini Mental State Test.;Disability Rating Scale. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Disability Rating Scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohsen Dalvandi

Arak University of Medical Sciences

dalvandi@arakmua.ac.ir+98 86 3222 2003

Outcome results

None listed

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