A Double-Blinded, Placebo-Controlled Exploratory Study to Investigate the Efficacy and Safety of Flexible dosing of Oral Lidocaine (ORE-001) to Reduce Abdominal Discomfort and Prevent Early Satiety in Anorexia Nervosa Patients

You likely can't join if

• Any contraindication as per summary of product characteristic for the usage of lidocaine.
• Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
• 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.
• Hypersensitivity to the IMP or to any excipients used in the formulation.
• 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.
• Patients with close affiliation with the Investigator or persons working at the respective study sites or patients who are an employee of the sponsor.