Agression MedDRA version: 20.0 Level: PT Classification code 10001488 Term: Aggression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
Oryzon Genomics S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women 18-85 years of age. 2. Body mass index (BMI) of at least 18.5 kg/m2. 3. Significant or persistent agitation or aggression that was disruptive to patient’s daily living or put the patient in harm´s way for at least 3 days per week for at least 4 weeks prior to screening visit. 4. MMSE score at Screening and Baseline Visits not greater than 16 but able to consent (only applicable to AD and LBD patients). 5. Outpatient consulting a general practitioner, or a psychiatrist/neurologist/geriatrician. 6. A current diagnosis for AD, LBD, ADHD, BPD or ASD according to DSM-5 criteria. 7. Knowledgeable and reliable close relative/caregiver who will accompany the patient to all clinic visits during the study (for all AD and for LBD, ASD patients as necessary based on the criteria of the clinician). 8. Stable pharmacological treatment as per SmPC of AD, LBD, ADHD, BPD or ASD for at least four months (with the same dose for at least two months) prior to screening – including anti-inflammatories. 9. Fertile male and female must use highly efficient contraception, from the Screening Visit until 30 days after last dose of the IMP, defined as: i. A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner) OR ii. The use of two methods of contraception (e.g. one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectable and implants]) 10. Signed informed consent by patient (or legal representative, if applicable) and a close relative/caregiver prior to the initiation of any study specific procedure. 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Failure to perform screening or baseline examinations. 2. Hospitalization or change of concomitant medication two months prior to Screening visit or during Screening Period. 3. Member or immediate family of the study personnel or subordinate (or immediate family of a subordinate) to any of the study personnel. 4. Patient under forced treatment. 5. Positive results for human immunodeficiency virus (HIV), hepatitis C or hepatitis B (hepatitis B surface antigen [HbsAg]) serology at the Screening Visit, or significant medical history, signs and symptoms for tuberculosis (TB) according to the investigator criteria. 6. Clinically significant, advanced or unstable disease that may interfere with evaluation: a. Seizures disorders b. Respiratory insufficiency (partial pressure of oxygen 2mg/dl) e. Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before Screening Visit) f. Hypertension treatment with more than 2 drugs g. Atrioventricular block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males >450 msec and females >470 msec) h. Uncontrolled diabetes (Hb1Ac >7.5) i. Haematological disorders, especially thrombocytopenia (platelets <75 000/mm3) and neutropenia (neutrophils <1 500/mm3) j. Malignant tumours within the last 5 years 7. Disability that may prevent the patients from completing all study requirements; for instance, blindness, deafness, severe language difficulty 8. Chronic drug intake of: a. Acenocoumarol, warfarin or digitoxin b. Antidepressants (other than selective serotonin reuptake inhibitors [SSRIs] or selective serotonin–norepinephrine reuptake inhibitors [SSNRIs]), antipsychotics (other than atypical antipsychotics), mood stabilizers (i.e. lithium or valproic acid). Note: Patients may be included if treated with a stable dose of SSRIs, SSNRIs, bupropion as antidepressants, benzodiazepines, zolpidem, or atypical antipsychotics, for at least four months before Screening Visit. c. Systemic anticholinergics d. Nootropics; for instance, racetams, anphetamines, metylphenidate, levodopa, atomoxetina, preparations containing Gingko biloba or St John's Wort e. Centrally active anti-hypertensive drugs (such as clonidine, a-methyldopa, guanidine, guanfacine) f. Corticosteroids or immunosuppressant (only inhaled or topical suspension are allowed). g. MAO inhibitors h. No regular intake of medications acting directly on central nervous system that investigator consider relevant to the study. 9. Suspected or known drug or alcohol abuse. 10. Enrolment in another investigational study or intake of investigational drug within the previous 3 months. 11. Suicide attempt within the last year or significant risk of suicide (in the opinion of the investigator, defined as a “yes” to suicidal ideation questions 4 or 5, or answering “yes” to suicidal behavior on the Columbia-Suicide Severity Rating Scale within the past 12 months) 12. Any condition that in the opinion of the investigator makes the patient unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of ORY-2001 in adult population with Alzheimer’s Disease (AD), Lewy Body Dementia (LBD), Adult attention deficit hyperactivity disorder (ADHD), Borderline Personality Disorder (BPD), Autism Spectrum Disorder (ASD);Secondary Objective: To investigate the efficacy of ORY-2001 in aggression in adult population with Alzheimer’s Disease (AD), Lewy Body Dementia (LBD), Adult attention deficit hyperactivity disorder (ADHD), Borderline Personality Disorder (BPD), Autism Spectrum Disorder (ASD);Primary end point(s): Primary Endpoints – Safety • Number, frequency and severity of Treatment Emergent Adverse Events (TEAEs) up to Week 8. • Number, frequency and severity of Serious TEAEs up to Week 8. • Number and percentage of withdrawn patients due to TEAEs up to Week 8. • Change from baseline to Week 8 in physical examination, vital signs and ECG parameters. • Frequency of physical examination parameters, vital signs and ECG parameters of potential clinical concern throughout the study period. • Change from baseline to Week 8 in clinical laboratory parameters (hematology, including platelets) and clinical chemistry. • Frequency of clinical laboratory parameters (hematology, including platelets, and clinical chemistry) of potential clinical concern throughout the study period. • Use of concomitant medication throughout the study period;Timepoint(s) of evaluation of this end point: 8 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints– Efficacy • Change from Baseline to Week 8 in the Neuropsychiatric Inventory Questionnaire (NPI) • Change over time in the NPI • Change from Baseline to Week 8 in the CGI-A • Change over time in the CGI-A • Change from Baseline to Week 8 in the Mini-Mental State Examination (MMSE) for AD and LBD patients • Change over time compared in the MMSE for AD and LBD patients • Change from Baseline to Week 8 in the ADHD-RS for ADHD patients • Change over time in the ADHD-RS for ADHD patients • Change from Baseline to Week 8 in the Autism Diagnostic Observation Schedule (ADOS) for ASD patients • Change over time in the ADOS for ASD patients • Change from Baseline to Week 8 in the Borderline Personality Disease Checklist (BPDCL) for BPD patients • Change over time in the BPDCL for BPD patients;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Countries
Spain
Contacts
Public ContactClinical Operations
Oryzon Genomics S.A.
Outcome results
None listed