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Pharmacokinetic Profiles of Subcutaneous vs. Intravenous Midazolam in Terminally Ill Patients in Palliative Care (PK-MID-PAL-study)
EU CTIS ID: 2025-521082-26-00
What this study is testing
To estimate the bioavailability of SC versus IV administration of midazolam in terminally ill patients
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Terminally ill patients with a life expectancy of less than one month.
- Patients receiving palliative care in the palliative care ward at the study site
- 18 years of age or older, at the time of signing the informed consent
- Capable of giving signed informed consent as described in Appendix 1 at inclusion, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- The attending physician finds the patient eligible for 1 mg of midazolam administered either SC or IV if symptoms commonly treated with parenteral midazolam, such as anxiety, restlessness, agitation, or insomnia, occur
You likely can't join if
- Known hypersensitivity to midazolam other benzodiazepines, or any of the excipients listed in point 6.1 of the SmPC for midazolam 1 mg/ml (B. Braun) (sodium chloride, hydrochloric acid, or water for injections).
- Strong indication for a dose of midazolam other than 1 mg, as judged by the attending physician
- Clear indication for administration of either IV or SC injection (by consensus of two senior consultants in palliative medicine).
- Received midazolam within the past 24 hours before study drug injection.
- No development of symptoms requiring midazolam within 5 days from inclusion.
- RASS PAL score of +3 or higher at the time of intervention, or if the next of kin, treating physician, or study personnel determine at that time that conducting serum measurements would pose a burden, even if consent has not been withdrawn.
See the full eligibility criteria
- Terminally ill patients with a life expectancy of less than one month.
- Patients receiving palliative care in the palliative care ward at the study site
- 18 years of age or older, at the time of signing the informed consent
- Capable of giving signed informed consent as described in Appendix 1 at inclusion, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- The attending physician finds the patient eligible for 1 mg of midazolam administered either SC or IV if symptoms commonly treated with parenteral midazolam, such as anxiety, restlessness, agitation, or insomnia, occur
- Known hypersensitivity to midazolam other benzodiazepines, or any of the excipients listed in point 6.1 of the SmPC for midazolam 1 mg/ml (B. Braun) (sodium chloride, hydrochloric acid, or water for injections).
- Strong indication for a dose of midazolam other than 1 mg, as judged by the attending physician
- Clear indication for administration of either IV or SC injection (by consensus of two senior consultants in palliative medicine).
- Received midazolam within the past 24 hours before study drug injection.
- No development of symptoms requiring midazolam within 5 days from inclusion.
- RASS PAL score of +3 or higher at the time of intervention, or if the next of kin, treating physician, or study personnel determine at that time that conducting serum measurements would pose a burden, even if consent has not been withdrawn.
- Intake of strong CYP3A4 inducers/inhibitors, as defined by the FDA (U.S. Food and Drug Administration, 2023), within the last 7 days or during the 90-minute intervention period..
- Hemoglobin < 9.0 g/dL.
- Acute respiratory depression, defined as a respiratory rate < 8 breaths per minute at the time of intervention
- Withdrawal of consent between inclusion and intervention, or at any other time
- Inability to establish venous access for blood sampling and/or IV injection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.