Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2018-002877-23-AT
• Date of registration: 07/12/2018
• Prospective Registration: Yes
• Primary sponsor: Abteilung für Neurologie der Medizinischen Universität Innsbruck
• Public title: Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD
• Scientific title: Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD
• Date of first enrolment: 21/01/2019
• Target sample size: 76
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002877-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: yes; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria

Contacts

• Name: Clinical Trial Center Neurology
• Affiliation: Medical University Innsbruck

• Name: Clinical Trial Center Neurology
• Affiliation: Medical University Innsbruck

Key inclusion & exclusion 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 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


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

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

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

Intervention(s)

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
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Nasal spray, solution
Route of administration of the placebo: Intranasal use (Noncurrent)

Primary Outcome(s)

Main Objective: To assess the effects of oxytocin in social saliency and emotional perception in healthy controls and patients with Parkinson's disease.

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

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: Screening
Visit 1
Visit 2

Secondary Outcome(s)

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

Secondary ID(s)

1.0

Source(s) of Monetary Support

Medical University Innsbruck

Ethics review

Status: Approved
Approval date: 06/12/2018
Contact: