BEHANDLING AV MENTAL UTTRÖTTBARHET ("HJÄRNTRÖTTHET") EFTER STROKE OCH SKALLSKADA MED DOPAMINSTABILISERAREN OSU6162 – UTÖKNING AV PATIENTANTALET

TREATMENT OF MENTAL FATIGUE ("BRAIN FATIGUE") WITH THE DOPAMINERGIC STABILIZER OSU6162 AFTER STROKE AND MILD/MODERATE TRAUMATIC BRAIN INJURY– INCREASE OF PATIENT NUMBER

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001650-29-SE

Enrollment

Registered

2011-10-06

Start date

2011-12-19

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

Mental fatigue after stroke or mild to moderate head trauma

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 stroke or a head trauma are attended to by the Department of Neurology, Sahlgrenska University Hospital (SU/S) 2. Age 30-65 years 3. 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 25 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 the self assessment questionaire, with focus on the mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a stroke or a head trauma;Secondary Objective: To study effects of OSU 6162 on objective neuropsychological tests, with focus on information processing speed and divided attention in the same patients.;Primary end point(s): To investigate the therapeutic effects of OSU 6162 as measured by a self assessment questionaire with focus on the mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a stroke or a head trauma	—

Measure

Time frame

Main Objective: Investigate the therapeutic effects of OSU 6162 as measured by the self assessment questionaire, with focus on the mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a stroke or a head trauma;Secondary Objective: To study effects of OSU 6162 on objective neuropsychological tests, with focus on information processing speed and divided attention in the same patients.;Primary end point(s): To investigate the therapeutic effects of OSU 6162 as measured by a self assessment questionaire with focus on the mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a stroke or a head trauma

—

Countries

Sweden

Contacts

Public ContactLars Rönnbäck

Sahlgrenska University Hoispital

lars.ronnback@neurogu.se+ 46(0)31342 10 00

Outcome results

None listed

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