Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery

Официальное название

Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery

Обзор

This study is testing whether oxytocin can help lessen pain by changing how people process emotions and social experiences. The goal is to better understand how the brain links emotions, relationships, and pain, and whether this connection can be used to improve pain treatment.

Подробное описание

This study employs a randomized, double-blind, placebo-controlled design to evaluate the efficacy of an intranasal oxytocin formulation, TNX-1900, on pain management, neural functioning, and socio-emotional health in patients undergoing pituitary surgery. Participants will be randomized into 3 groups: One group will receive low-dose oxytocin (6 IU), one group will receive high-dose oxytocin (24 IU), and one group will receive a matching placebo formulation. Participants will administer their nasal spray (blinded) daily for 7 days leading up to, and including the day of surgery, and 7 days following the surgery. Assessments (surveys and EEG/ERP) will be included throughout the protocol.

Вмешательства

• Препарат Oxytocin (Low dose)
  The dosage for low -dose intranasal oxytocin is set at 6 International Units (IU) per day, divided into two administrations of 3IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
• Препарат Oxytocin (High dose)
  The dosage for high-dose intranasal oxytocin is set at 24 International Units (IU) per day, divided into two administrations of 12 IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
• Препарат Placebo (saline)
  Placebo nasal spray (no study medication, magnesium only). The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.

Первичные конечные точки

• Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS) [Срок оценки: Pre-op up to 8 weeks after last drug administration]
• Change in post-operative pain measured by monitoring of pain medication usage [Срок оценки: Pre-op up to 8 weeks after last drug administration]

Вторичные конечные точки (5)

• Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II) [Срок оценки: Pre-op up to 8 weeks after last drug administration]
• Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI) [Срок оценки: Pre-op up to 8 weeks after last drug administration]
• Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7 [Срок оценки: Pre-op up to 8 weeks after last drug administration]
• Changes in participant reported depression as measured by the Patient Health Questionnaire-9 [Срок оценки: Pre-op up to 8 weeks after last drug administration]
• Change in neural functioning measured by Electroencephalography (EEG)/Event-Related Potential (ERP) [Срок оценки: Pre-op and the last day of drug administration, approximately 14 days]

Критерии участия

Критерии включения

• Age: Between 30 to 75 years old.
• Consent: Ability to give informed consent.
• Language: Proficiency in the English language.
• Medical Condition: Diagnosed with a pituitary lesion requiring surgery.
• Menopausal Status: Post-menopause for women (at least 1 year since last menstrual period).

Критерии исключения

• Medication: Individuals on stable doses of psychotropic medication for at least the past six weeks are eligible, excluding those with changes in medication within that timeframe.
• Neurological Conditions: A history of seizures, current use of anticonvulsants.
• Pregnancy: Currently pregnant, currently lactating, or up to 1-year post partum.
• Any history of renal impairment (serum creatinine >1.2 x ULN)
• Any history of hepatic impairment (AST and/or ALT >2 x ULN)
• Surgical History: Any history of previous pituitary surgery procedures
• Subjects who require 24-hour coverage with NSAIDs, e.g., arthritis, should not be included in the study.
• Any known hypersensitivity to TNX-1900

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Yale University — New Haven

Идентификаторы

NCT: NCT07730294 · 2000042469

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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