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

Double-blind placebo controlled study of the effects of OSU6162 on chronic fatigue in patients who suffered a mild traumatic brain injury

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004990-10-SE

Enrollment

Registered

2011-10-19

Start date

2012-01-09

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

Mental fatigue after traumatic brain injury

Interventions

Product Code: OSU 6162 similar to (-)-OSU 6162 Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Countries

Sweden

Outcome results

None listed

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