Social functioning in Parkinson's disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Syntocinon 40 IU/ml nasal spray
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Synthetic Oxytocin
CAS Number: 50-56-6
Other descriptive name: OXYTOCIN SYNTHETIC
Concentra
Sponsors
Abteilung für Neurologie der Medizinischen Universität Innsbruck
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion criteria for participants with PD: 1. Age 30 – 70 years 2. Male 3. Confirmed diagnosis of idiopathic Parkinson’s disease for at least 3 years according to the UK Brain Bank criteria 4. On a stable regimen of anti-parkinson medication (such as L-Dopa, Amantadine, Anticholinergics, COMT inhibitors, dopamine agonists and MAO-B inhibitors) for at least three weeks prior to screening and willing to continue the same doses and regimens during study participation 5. Any other current and allowed prescription/ non prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least three weeks prior to screening, and participants must be willing to continue the same doses and regimens during study participation 6. Able and willing to sign a current IRB-approved informed consent form 7. Acceptable method of contraception Inclusion criteria for healthy controls: 1. Participants without PD or significant neurological disorder 2. Age 30 - 70 years 3. Male 4. Able and willing to sign a current IRB-approved informed consent form 5. Acceptable method of contraception 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) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: Exclusion criteria for participants with PD: 1. Participants taking prostaglandins and/or vasoconstrictors/sympathomimetics (eg. COPD/asthma medication such as salbutamol, fenoterol; inotropics such as dobutamin; rhinitis therapy such as ephedrine), as oxytocin can interact with these drugs 2. Current or recent (within 30 days or 5 half-times of the IMP, prior to screening) participation in another study with an investigational medicinal product 3. Known allergy or hypersensitivity to any component of the IMPs 4. Females 5. Atypical or secondary parkinsonism (such as vascular Parkinsonism, drug induced Parkinsonism, Wilson’s disease, Alzheimer’s disease and Creutzfeld-Jacob disease) 6. Known abnormality in CT or MRI brain imaging which is considered to cause neurological symptoms or deficits 7. Concurrent dementia defined by MMSE =24 8. Presence of an acute or chronic major psychiatric disorder (e.g., hallucinations, agitation, paranoia) 9. History of severe cardiac disease (Angina, myocardial infarction, atrial fibrillation or cardiac surgery in the preceding two years) 10. History of end stage kidney or liver disease 11. Any other uncontrolled disease or any disease considered relevant by the investigator 12. Nicotine consumption of more than 10 cigarettes per day 13. Known allergy or hypersensitivity to latex rubber, due to possible cross-reactions 14. Patient is legally incapacitated or persons held in an institution by legal or official order 15. Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator Exclusion Criteria for healthy controls: 1. Participants taking prostaglandins and/or vasoconstrictors/sympathomimetics (eg. COPD/asthma medication such as salbutamol, fenoterol; inotropics such as dobutamin; rhinitis therapy such as ephedrine), as oxytocin can interact with these drugs 2. Current or recent (within 30 days or 5 half-times of the IMP, prior to screening) participation in another study with an investigational medicinal product 3. Known allergy or hypersensitivity to any component of the IMPs 4. Females 5. Any known neurological disease 6. Known abnormality in CT or MRI brain imaging which is considered to cause neurological symptoms or deficits 7. Concurrent dementia defined by MMSE =24 8. Presence of an acute or chronic major psychiatric disorder (e.g., hallucinations, agitation, paranoia) 9. History of severe cardiac disease (Angina, myocardial infarction, atrial fibrillation or cardiac surgery in the preceding two years) 10. History of end stage kidney or liver disease 11. Any other uncontrolled disease or any disease considered relevant by the investigator 12. Nicotine consumption of more than 10 cigarettes per day 13. Known allergy or hypersensitivity to latex rubber, due to possible cross-reactions 14. Personality change (eg. increased aggression potential, irritability, at risk for substance abuse disorder/impulsive-compulsive behavior) 15. Participantis legally incapacitated or persons held in an institution by legal or official order 16. Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of oxytocin in social saliency and emotional perception in healthy controls and patients with Parkinson's disease.;Secondary Objective: Not applicable;Primary end point(s): •Number of fixations towards social stimuli in naturalistic scenes •Duration of fixations towards social stimuli in naturalistic scenes •Latency to first fixation towards social stimuli •Number of fixations towards the eye region •Duration of fixations towards the eye region •Latency to first fixation towards the eye region •Error rate in recognizing emotions ;Timepoint(s) of evaluation of this end point: Screening Visit 1 Visit 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Changes in reaction times in pro- and antisaccadic tasks (ms) •Changes in errorrates in pro- and antisaccadic tasks •Changes in the score of the Delayed Discounting Test Safety and tolerability endpoints: •Tolerability •Number of subjects (%) who discontinue the study •Number of subjects (%) who discontinue the study due to AE •Safety Measures •Adverse Events (AE) •Clinical assessments •Vital signs;Timepoint(s) of evaluation of this end point: Screening Visit 1 Visit 2 | — |
Countries
Austria
Contacts
Public ContactClinical Trial Center Neurology
Medical University Innsbruck
Outcome results
None listed