The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
Public ClinicalTrials.gov record NCT07197034. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07197034
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 19 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 23, 2024 (Actual)
- Primary completion
- Apr 15, 2026 (Actual)
- Completion
- Apr 15, 2026 (Actual)
- Last update posted
- Jun 30, 2026
2024 – 2026
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233-1711 | — |
| Children's Hospital of Orange Country | Orange | California | 92868 | — |
| Stanford Children's Health Specialty Services | Palo Alto | California | 94304 | — |
| Rady Children's Hospital | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Denver | Colorado | 80045-7106 | — |
| Nemours Children's Clinic Wilmington | Wilmington | Delaware | 19803-3607 | — |
| UF Shands Children's Hospital | Gainesville | Florida | 32610-3008 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322-1047 | — |
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611-2991 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287-0005 | — |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55102 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219-2918 | — |
| NYU Langone Children's Ambulatory Care Center | Mineola | New York | 11501-4077 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-0005 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07197034, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07197034 live on ClinicalTrials.gov.