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Modafinil in improving the consciousness level of patients with diffuse axonal injury

Investigating the effectiveness and safety of Modafinil in improving the level of consciousness in patients with diffuse axonal injury: a randomized, double-blind, placebo-controlled clinical trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190810044500N26
Enrollment
60
Registered
2024-08-29
Start date
2024-08-22
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

The consciousness coefficient in patients with axon diffusion. Disorders of multiple cranial nerves

Interventions

Intervention 1: Patients in the intervention group will receive two doses of Modafinil 100 mg (manufactured by Subhan Pharmaceutical Company) daily. Intervention 2: Patients in the control group will

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 75 years Patients who did not have a serious life-threatening illness before the brain injury diagnosed with diffuse axonal damage based on neurosurgery expert diagnosis and imaging findings. patients who are able to receive medication by oral or nasogastric tube.

Exclusion criteria

Exclusion criteria: Lack of informed consent by the patient's first-degree relatives severe intracranial hematoma and Progressing and/or extensive brain contusion with an indication for surgery participation in another clinical trial within the last month spinal cord injury penetrating head injury chronic steroid use history of cerebrovascular injury, brain tumor or previous traumatic brain injury midline change of more than 5 mm and/or bilateral or extensive brain contusion and/or subarachnoid hemorrhage identified on CT scan or MRI failure Kidney pregnancy history of allergy to modafinil drug

Design outcomes

Primary

MeasureTime frame
GCS score and GOS score. Timepoint: Three and six months after head trauma. Method of measurement: Assessment of cognitive level.

Secondary

MeasureTime frame
MMSE score. Timepoint: 0,1,3 and 7 days and discharge day. Method of measurement: MMSE scores are considered as normal cognitive function with a score of 25-30, mild impairment with a score of 20-24, moderate impairment with a score of 10-19, and severe impairment with a score of 0-9.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Fateme Saghafi

Yazd University of Medical Sciences

F.saghafi@ssu.ac.ir+98 38203419

Outcome results

None listed

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