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Setmelanotide in the ROHHAD-syndrome (ROH-SET study)
EU CTIS ID: 2024-516753-45-00
What this study is testing
To evaluate the effect of setmelanotide on hypothalamic dysfunction in 5 patients with the ROHHAD syndrome after 16 weeks, 32 weeks and 52 weeks
- 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
- Patient is diagnosed with ROHHAD syndrome by a pediatric endocrinologist
- Aged 4 years and older at time of enrolment
- Ability to communicate well with the Investigator, understand and sign the written informed consent and/or assent for patients aged <18 years, a parent/legal guardian that can sign.
You likely can't join if
- Patients with hypothalamic dysfunction attributable to other conditions (eg suprasellar tumor)
- Patients with obesity attributable to other genetic or syndromic conditions (eg, PPL [POMC, PCSK1, LEPR, collectively], BBS, Prader-Wili syndrome)
- History or close family history (parents or siblings) of skin cancer or melanoma (not including noninvasive, infiltrative basal or squamous cell lesion), or patient history of ocular-cutaneous albinism.
- Inability to comply with once daily (QD) injection regimen.
- Pregnant and/or breastfeeding or desiring to become pregnant during this study.
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, 0-17 years, 18-64 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.