IRCT | 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.

Protocol summary

Study aim: Effectiveness of modafinil drug in improving the conscious coefficient in patients with diffuse axonal injury
Design: Patients in the intervention and control groups will receive 100 mg of modafinil and placebo BD, respectively. Mechanical ventilation duration, ICU length of stay, GCS score at baseline and discharge, SOFA and GOS, and the mortality rate will also be calculated and recorded for each patient.
Settings and conduct: Shahid Dr. Rahnamoon Hospital in Yazd
Participants/Inclusion and exclusion criteria: Patients aged 18-75 years and diagnosed with diffuse axonal damage based on neurosurgery expert diagnosis and imaging findings.Patients who didn't have a serious life-threatening illness before the brain injury and patients who can receive medication orally. Exclusion criteria: Lack of informed consent by the patient's first-degree relatives, spinal cord injury, penetrating head injury, chronic steroid use, history of cerebrovascular injury, brain tumor or previous traumatic brain injury, kidney failure, pregnancy, and history of allergy to modafinil drug
Intervention groups: The Intervention group received medafinyl drug and the control group received placebo tablets
Main outcome variables: The consequences of the measurement include GCS Score and Scor GOS are basic, three and six months after head trauma. In Scor GOS, the death of Scor 1 and full scores. Also, for cognitive level assessment, 3 and 6 months after trauma, MINI-MENTAL STATE EXAMINATION (MMSE) is measured

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20190810044500N26

Registration date: 2024-08-29, 1403/06/08

Registration timing: registered_while_recruiting

Last update: 2024-08-29, 1403/06/08

Update count: 0
Registration date: 2024-08-29, 1403/06/08

Registrant information: Name

Fatemeh Saghafi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 35 3820 3419

Email address

f.saghafi@ssu.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-08-22, 1403/06/01
Expected recruitment end date: 2025-02-19, 1403/12/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: 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.

Public title: Modafinil in improving the consciousness level of patients with diffuse axonal injury
Purpose: Treatment
Inclusion/Exclusion 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:

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
Age: From 18 years old to 75 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Care provider
Outcome assessor

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

By using the table of random numbers and using the Random allocation software version 1.0 under Windows, we generate a random sequence using a simple random allocation method. In this table, numbers from 1 to 60 are specified and each number is assigned to an intervention group (A and B).

Blinding (investigator's opinion)

Double blinded

Blinding description

Study participants and the research team remain unaware of which patient has used which type of medication.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

The Ethics Committee of the Faculty of Medicine - Shahid Sadougi University of Medical Sciences, Yaz

Street address

Shahid Sadoughi University of Medical Science, Shohaday Gomnam Blvd,Yazd

City

yazd

Province

Yazd

Postal code

8915173143
Approval date: 2024-07-06, 1403/04/16
Ethics committee reference number: IR.SSU.MEDICINE.REC.1403.057

Health conditions studied

1

Description of health condition studied: The consciousness coefficient in patients with axon diffusion
ICD-10 code: G52.7
ICD-10 code description: Disorders of multiple cranial nerves

Primary outcomes

1

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

Secondary outcomes

1

Description: 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.

Intervention groups

1

Description: Patients in the intervention group will receive two doses of Modafinil 100 mg (manufactured by Subhan Pharmaceutical Company) daily.
Category: Treatment - Drugs

2

Description: Patients in the control group will use a placebo tablet (manufactured by the pharmaceutics laboratory of Yazd University of Medical Sciences) twice a day, which has the same shape and appearance as Modafinil tablets
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Shahid Dr. Rahnemoon hospital Yazd

Full name of responsible person

Nargess Khakzar

Street address

Farokhi street

City

Yazd

Province

Yazd

Postal code

۸۹۱۵۱۷۳۱۴۹

Phone

+98 35 3626 0001

Email

Rahnemoonhospital@ssu.ac.ir

Web page address

https://web.ssu.ac.ir/index.aspx?lang=1&sub=4

1

Sponsor: Name of organization / entity

Yazd University of Medical Sciences

Full name of responsible person

Amin Salehi

Street address

Professor Hesabi Blvd., Yazd Province, Yazd, Iran

City

yazd

Province

Yazd

Postal code

۸۹۱۵۱۷۳۱۴۹

Phone

+98 35 3820 3419

Email

F.saghafi@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Yazd University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Yazd University of Medical Sciences

Full name of responsible person

Dr.Fateme Saghafi

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Medical Pharmacy

Street address

Professor Hesabi Blvd., Yazd Province, Yazd, Iran

City

Yazd

Province

Yazd

Postal code

۸۹۱۵۱۷۳۱۴۹

Phone

+98 38203419

Email

F.saghafi@ssu.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Yazd University of Medical Sciences

Full name of responsible person

Dr Fateme Saghafi

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Medical Pharmacy

Street address

Yazd-Yazd-Shohaday gomnam Blvd-Shahid Sadoughi University of Medical Sciences

City

Yazd

Province

Yazd

Postal code

8915173143

Phone

+98 35 3820 3419

Email

Saghfi.Fa@gmail.comhs

Person responsible for updating data

Contact: Name of organization / entity

Yazd University of Medical Sciences

Full name of responsible person

Dr Fateme Saghafi

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Medical Pharmacy

Street address

Professor Hesabi Blvd., Yazd Province, Yazd, Iran

City

Yazd

Province

Yazd

Postal code

8915173149

Phone

+98 35 3820 3419

Email

F.saghafi@ssu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

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.