A study of the effects of OSU6162 on chronic fatigue in patients who suffered a mild traumatic brain injury

Phase 1

• Conditions: Mental fatigue after traumatic brain injury; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004990-10-SE
• Lead Sponsor: Sahlgrenska Academy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-19
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients who > 12 months earlier suffered a traumatic brain injury are attended to the Department of Neurorehabilitation, Northern University Hospital.
2. Age 18-65.
Glasgow Outcome Scale (extended), moderate disability (appr 5) or better recovery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Significant co-morbidity including psychiatric or neurological disorder.
2. Women of childbearing potential not on contraceptives.
3. Pregnant women.
4. Alcohol or drug abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the therapeutic effects of OSU 6162 as measured by self assessment questionnaire, with focus on mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a traumatic brain injury.;Secondary Objective: To study the effects of OSU 6162 on objective measures such as neuropsychological testing and functional magnetic resonance imaging, with focus on mental fatigue, and cognitive capacity in patients with mental fatigue who suffered a traumatic brain injury.;Primary end point(s): Investigate the therapeutic effects of OSU 6162 as measured by self assessment questionnaire, with focus on mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a traumatic brain injury.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To study the effects of OSU 6162 on objective measures such as neuropsychological testing and functional magnetic resonance imaging, with focus on mental fatigue, and cognitive capacity in patients with mental fatigue who suffered a traumatic brain injury.