E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Social functioning in Parkinson's disease |
Sozial-kognitive Funktionen bei der Parkinson Erkrankung |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effects of oxytocin in social saliency and emotional perception in healthy controls and patients with Parkinson's disease. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Exploratory study on effects of oxytocin on emotional perception in healthy controls and patients with Parkinson's disease. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |