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.

• Register: EUCTR
• Last refreshed on: 7 December 2020
• Main ID: EUCTR2013-002545-10-SE
• Date of registration: 11/11/2013
• Prospective Registration: Yes
• Primary sponsor: A. Carlsson Research AB
• Public title: 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.
• Scientific title: 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
• Date of first enrolment: 08/01/2014
• Target sample size: 240
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002545-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: open; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Sweden

Contacts

• Name: C.G. Gottfries
• Affiliation: Gottfries Clinic AB

• Name: C.G. Gottfries
• Affiliation: Gottfries Clinic AB

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Intervention(s)

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

Primary Outcome(s)

Secondary Objective: We will also explore the value of new objective measuring methods
concerning movement patterns and level of activitry.

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.

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 Outcome(s)

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).

Secondary ID(s)

OSU6162Open1309

Source(s) of Monetary Support

A. Carlsson Research AB

Ethics review

Status: Approved
Approval date: 02/12/2013
Contact: