Trials / Suspended
SuspendedNCT07197034
The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome
- Status
- Suspended
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Aardvark Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS) when used in a long term setting. It will also teach us about the safety of ARD-101. The main questions it aims to answer are: What medical problems do participants have when taking ARD-101 in a long term setting Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? Eligible participants will: Have completed treatment on the AVK-101-301 study through Week 12/End of Treatment Take ARD-101 every day for up to 12 months. Visit the clinic at Months 1, 3, 6 and 12 during dosing and then have tele-visits at Week 2, Months 3 and 9, then 4 weeks after stopping the ARD-101. Patients/Caregivers will keep a daily diary.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ARD-101 | 200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks |
Timeline
- Start date
- 2024-07-23
- Primary completion
- 2027-03-01
- Completion
- 2027-04-01
- First posted
- 2025-09-29
- Last updated
- 2026-03-19
Locations
30 sites across 5 countries: United States, Australia, Canada, South Korea, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07197034. Inclusion in this directory is not an endorsement.