Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT06009003
Eligibility Criteria:
Inclusion Criteria:
* Patients who may potentially benefit from treatment with esmethadone (REL-1017) as determined by the treating physician.
* Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition.
* Are ineligible or unable to participate in any ongoing clinical study of the investigational product.
* Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated risks.
Exclusion Criteria:
* History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
* History of QTc prolongation.
* History of allergy or hypersensitivity to methadone or related drugs.
* Pregnant or planning to become pregnant.
* Breast-feeding or planning to breast-feed.
Sex:
ALL
Study:
NCT06009003
Study Brief:
Protocol Section:
NCT06009003