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

Phase 1

• Conditions: Mental fatigue after stroke or mild to moderate head trauma; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001650-29-SE
• Lead Sponsor: A. Carlsson Research AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-06
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

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

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 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