An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.

An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. - OSU6162Open1309

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002545-10-SE

Enrollment

240

Registered

2013-11-11

Start date

2014-01-08

Completion date

Unknown

Last updated

2020-12-07

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

Conditions

Parkinsons disease Huntingtons disease Multiple scleros Brain trauma Stroke Myalgic encephalomyelitis Narcolepsy

Interventions

Product Code: OSU6162 similar to (-)-OSU 6162 Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient should sign informed consent. Should be 18-75 years old. Women of child bearing age should be on contraceptives. Patients with brain trauma and stroke should have a minimal time period of 12 months since onset/diagnosis and a minimal of three months fatigue. Patients should fulfil international criterias for one of the diseases listed in the project title. 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 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Patients with unstable medication. Patients with abuse problems. Patients suffering from other serious somatic or psychiatric diseases. Becks depression scale 30 points or more at V1 och V2 Pregnant women (pregnancy test V1 and V7). Breast feeding women. Patients with aberrant laboratory investigations of serious degree. Pathological ECG Maximal QTc on ECG: 450 ms for men and 460 ms for women. Pathological UCG heart. Patients mentally or somatically reduced so they can not participate in ratings or other methods for evaluating effect. Patients receiving therapy with Modiodal, Xyrem , mirtazapin, metabolic enzyme inhibitors, metabolic enzyme inducers and drugs with a narrow therapeutic window (i.e. warfarine, antieoileptics , cyclosporine, tacrolimus, individually dose titrated drugs i.e. lithium) are excluded. Patients should not participate in any other Clinical studies.

Design outcomes

Primary

Measure	Time frame
Main Objective: An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.;Secondary Objective: We will also explore the value of new objective measuring methods concerning movement patterns and level of activitry.;Primary end point(s): Safety of OSU6162. Recording of adverse events on doses between 5 - 90 mg per day in patients with Parkinson's disease, Huntington's disease,multiple sclerosis,brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. ;Timepoint(s) of evaluation of this end point: After three months open study. (6 and 12 months for stroke).	—

Measure

Time frame

Main Objective: An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.;Secondary Objective: We will also explore the value of new objective measuring methods concerning movement patterns and level of activitry.;Primary end point(s): Safety of OSU6162. Recording of adverse events on doses between 5 - 90 mg per day in patients with Parkinson's disease, Huntington's disease,multiple sclerosis,brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. ;Timepoint(s) of evaluation of this end point: After three months open study. (6 and 12 months for stroke).

—

Secondary

Measure	Time frame
Secondary end point(s): We will also explore the value of objective new techniques for measuring movements and activity levels before and after three months treatment (6 and 12 months for stroke).;Timepoint(s) of evaluation of this end point: Three months open study (6 and 12 months for stroke).	—

Countries

Sweden

Contacts

Public ContactC.G. Gottfries

Gottfries Clinic AB

cgg@gottfries.se+46313432397

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 8, 2026