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The effect of Gabapentin in traumatic brain injury

The effect of Gabapentin (vs. placebo) in improvement of consciousness level of traumatic brain injury patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201009204786N1
Enrollment
60
Registered
2010-11-12
Start date
2008-03-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Diffuse brain injury. Diffuse brain injury

Interventions

Intervention 1: The intervention group is treated by 300 mg Gabapentin twice daily. Intervention 2: The control group is treated by placebo twice daily.
Treatment - Drugs
Placebo
The intervention group is treated by 300 mg Gabapentin twice daily
The control group is treated by placebo twice daily

Sponsors

Vice chancellery for research, Isfahan university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients who suffered from moderate (9 12) and severe (GCS<9) traumatic brain injury and diffuse axonal injury were included. The exclusion criteria were: the patient death during the study and the patients who did not tolerate gabepentin or present its severe side effects.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Glasgow Coma Scale. Timepoint: before intervention, 1 and 2 weeks after intervention onset, at the first outpatient referral. Method of measurement: Physical examination.;Glasgow outcome scale. Timepoint: before intervention, 1 and 2 weeks after intervention onset, at the first outpatient referral. Method of measurement: Physical examination.

Secondary

MeasureTime frame
Electroencephalography. Timepoint: before intervention, 1 and 2 weeks after intervention onset, at the first outpatient referral. Method of measurement: Electroencephalography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Ali Sonbolestan

Isfahan university of medical sciences

sonbolestan@edc.mui.ac.ir+93 3117922295

Outcome results

None listed

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