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A Long-term Extension Study of ORX750 in Participants with Narcolepsy and Idiopathic Hypersomnia
EU CTIS ID: 2025-522987-34-00
What this study is testing
To evaluate the long-term safety and tolerability of ORX750
- 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
- All Participants: • Participants with narcolepsy (NT1 or NT2) or IH who have completed the full treatment period in Study ORX750-0201. • Participants must be able and willing to participate in all scheduled evaluations and procedures per protocol and must agree to be available to complete all study measurements and comply with study restrictions. • Male and female participants must comply with contraception requirements described in the protocol.
- Returning Participants Only: o 18-65 years of age o BMI ≥17.0 and ≤37 kg/m2 o Estimated glomerular filtration rate ≥60 mL/min/1.73 m2 o Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia o Is willing and able to adhere to additional protocol requirements
- Rollover Participants Only: o Each participant must provide written informed consent by the final treatment visit (Day 42) in Study ORX750-0201, before the performance of any study-related procedures in the LTE study
You likely can't join if
- Returning Participants Only: • Participant has a medical condition(s) other than NT1, NT2, or IH for which excluded medications should not be discontinued. • Participant has participated in a study with an investigational drug other than ORX750 within the previous 30 days or within 5 half-lives of the investigational drug administration, whichever is longer, calculated from the last dose of the investigational drug or any AE related to the prior study to the screening day. • Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease.
- Rollover Participants Only: o Development of any new disease/disorder that in the opinion of the investigator would make the participant unable to continue the study.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. Enter your location above to see the nearest site and check your eligibility.
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.