LIDOCAINE HYDROCHLORIDE MONOHYDRATE for Anorexia nervosa

Inclusion criteria

• {"criterion_text":"- Patients must be able to understand the requirements of the study and give written informed consent prior to study start.\n- Female between 18 and 45 years of age (both inclusive).\n- Patients requiring hospitalization and under psychological treatment for anorexia nervosa for at least 3 months.\n- Patient is highly likely to comply with the protocol and complete the study.\n- BMI at baseline ˃13 (moderate-to-severe AN according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n- Classified as restricting and binge-eating/purging types of AN according to DSM-5.\n- Diagnosis of anorexia nervosa according to DSM-5 criteria."}

Exclusion criteria

• {"criterion_text":"- Any contraindication as per summary of product characteristic for the usage of lidocaine.\n- Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.\n- Pregnancy, lactation, or planning to become pregnant during the study. Females of childbearing potential must have a negative pregnancy test prior to starting treatment and practice highly effective methods of birth control throughout the study period (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy). Highly effective contraceptives measures according to CTCG recommendation, version 1.2, 07 March 2024, are: a. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral/intravaginal/transdermal or progestogen-only hormonal contraception associated with inhibition of ovulation: oral/ injectable/ implantable for at least 3 months prior to dosing and continuing through the study completion. b. Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) for at least 3 months prior to dosing and continuing through the study completion. c. Bilateral tubal occlusion. d. Vasectomized partner. e. Sexual abstinence. Note: Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate, history of vasomotor symptoms) or have FSH level of at least 40 U/ml at screening (to confirm menopause) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.\n- Hypersensitivity to the IMP or to any excipients used in the formulation.\n- Any other condition, including but not limited to epilepsy, myasthenia gravis, cardiac conduction disturbances, congestive heart failure, bradycardia, severe shock, impaired respiratory function or impaired renal function with creatinine clearance (CrCl) less than 10 ml/min, which in the opinion of the investigator precludes the patient’s participation in the study.\n- Patients with close affiliation with the Investigator or persons working at the respective study sites or patients who are an employee of the sponsor.\n- History of uncontrolled (at the discretion of the investigator) cardiovascular, renal, hepatic and/or liver failure.\n- History of severe allergic or anaphylactic reactions, especially to local anesthetics.\n- Clinically significant (at the discretion of the investigator) abnormal ECG.\n- Intake of any class 1B antiarrhythmic drugs if used for antiarrhythmic purpose (e.g., lidocaine, mexiletine, phenytoin) and of any class 3 antiarrhythmic drugs - potassium channel blockers (e.g., amiodarone, dronedarone, sotalol, ibutilide, dofetilide, bretylium).\n- Intake of concomitant medication that has an impact on stomach pH like proton pump inhibitors. These compounds may have an impact on the bioavailability of the ORE-001.\n- Significant (at the discretion of the investigator) symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection (especially with need of antibiotic treatment) within the past 2 weeks prior to study medication administration."}

Primary endpoints

• {"endpoint_text":"- Difference between ORE-001 and placebo in change from baseline in VAS scores for satiety sensations on Day 28","definition_or_measurement_approach":"Change from baseline in Visual Analogue Scale (VAS) scores for satiety sensations measured on Day 28; comparison of ORE-001 versus placebo."}

Secondary endpoints

• {"endpoint_text":"- Difference between ORE-001 and placebo in change from baseline in late fullness (prior to lunch) in VAS scores for satiety sensations on Day 28","definition_or_measurement_approach":"Change from baseline in VAS scores for late fullness (prior to lunch) on Day 28; comparison ORE-001 versus placebo."}
• {"endpoint_text":"- Difference between ORE-001 and placebo in change from baseline in VAS score for GI symptoms on Day 28","definition_or_measurement_approach":"Change from baseline in VAS score for gastrointestinal (GI) symptoms on Day 28; comparison ORE-001 versus placebo."}
• {"endpoint_text":"- Difference between ORE-001 and placebo in change from baseline in body weight at Day 28.","definition_or_measurement_approach":"Change from baseline in body weight measured at Day 28; comparison ORE-001 versus placebo."}
• {"endpoint_text":"- Daily change from baseline in the weight of food and calorie intake per meal.","definition_or_measurement_approach":"Daily measurement of weight of food consumed and calorie intake per meal compared to baseline."}
• {"endpoint_text":"- Difference between ORE-001 and placebo in change from baseline in total IEDOQL score on Day 28.","definition_or_measurement_approach":"Change from baseline in total IEDOQL (quality of life) score on Day 28; comparison ORE-001 versus placebo."}
• {"endpoint_text":"- Difference between ORE-001 and placebo in change from baseline in MOS sleep scale on Day 28.","definition_or_measurement_approach":"Change from baseline in MOS sleep scale on Day 28; comparison ORE-001 versus placebo."}
• {"endpoint_text":"- Treatment-Emergent Adverse Events (AE) and serious adverse events (SAE) up to end of study","definition_or_measurement_approach":"Recording and reporting of treatment-emergent adverse events and serious adverse events throughout the study up to end of study."}
• {"endpoint_text":"- Change from Baseline in the levels of biomarkers (Leptin, ghrelin, oxytocin, peptide Y (PYY), and brain-derived neurotropic factor (BDNF)) associated with satiety at End of Treatment","definition_or_measurement_approach":"Change from baseline in blood/plasma levels of listed biomarkers (Leptin, ghrelin, oxytocin, PYY, BDNF) measured at End of Treatment."}

Italy

Earliest CTIS Part Ii Submission Date

17-12-2024

Latest Decision Or Authorization Date

12-02-2025

Processing Time Days

57

Number Of Sites

1

Number Of Participants

18

Primary sponsor

Full Name

Orexa B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands

Third parties

• {"country":"Netherlands","full_name":"Eurofins Bactimm B.V.","duties_or_roles":"microbiological testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Netherlands","full_name":"Ofimedicine B.V.","duties_or_roles":"producer drug substance","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"Contract negotiation","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Synergy Health Utrecht B.V.","duties_or_roles":"stability testing","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"packaging and labelling","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Zwiers Regulatory Consultancy B.V.","duties_or_roles":"pharmacovigilance","organisation_type":"Pharmaceutical company"}