A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients With Prader-Willi Syndrome

Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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). It will also teach us about the safety of ARD-101. The main questions it aims to answer are: * Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? * What medical problems do participants have when taking ARD-101? Researchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects. Eligible participants will: * Take ARD-101 or a placebo every day for 12 weeks. * Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo. * Patients/Caregivers will keep a daily diary. Participants who complete the study may be eligible to enter an open-label extension study where everyone will receive ARD-101.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Healthy Volunteers: f
View:

• Documented confirmation of Prader-Willi Syndrome (PWS)

• Stable care setting with same, single designated caregiver for at least 6 months prior to Visit 1

Locations
United States
Alabama
Children's of Alabama
RECRUITING
Birmingham
California
Rady Children's Hospital
RECRUITING
Encinitas
Children's Hospital of Orange Country
NOT_YET_RECRUITING
Orange
Stanford Childrens Health Specialty Services
RECRUITING
Palo Alto
Colorado
Childrens Hospital Colorado
RECRUITING
Denver
Delaware
Nemours Children Clinic Wilmington
RECRUITING
Wilmington
Florida
UF Shands Childrens Hospital
RECRUITING
Gainesville
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago
NOT_YET_RECRUITING
Chicago
Maryland
The Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
Minnesota
University of Minnesota Masonic Children's Hospital
RECRUITING
Minneapolis
New York
Maimonides Medical Center
RECRUITING
Brooklyn
NYU Langone Children's Ambulatory Care Center
RECRUITING
Mineola
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Cook Children's Medical Center
RECRUITING
Fort Worth
Texas Valley Clinical Research, LLC
WITHDRAWN
Weslaco
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Queensland Children's Hospital
RECRUITING
South Brisbane
The Children's Hospital at Westmead
NOT_YET_RECRUITING
Westmead
Canada
Alberta Children's Hospital Research Institute
NOT_YET_RECRUITING
Calgary
Li Ka Shing Centre for Health Research Innovation
NOT_YET_RECRUITING
Edmonton
Centre Hospitalier Universitaire Sainte-Justine
NOT_YET_RECRUITING
Montreal
France
CHU d'Angers
NOT_YET_RECRUITING
Angers
AP-HP - Hôpital de la Pitié Salpétrière
NOT_YET_RECRUITING
Paris
AP-HP - Hôpital universitaire Necker-Enfants malades
NOT_YET_RECRUITING
Paris
CHU de Toulouse- Hôpital de Rangueil
NOT_YET_RECRUITING
Toulouse
CHU de Toulouse-Hôpital Des Enfants
NOT_YET_RECRUITING
Toulouse
Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
NOT_YET_RECRUITING
Florence
Ospedale San Raffaele S.r.l. - PPDS
NOT_YET_RECRUITING
Milan
Ospedale Pediatrico Bambino Gesù IRCCS
NOT_YET_RECRUITING
Rome
Republic of Korea
Inha University Hospital
NOT_YET_RECRUITING
Incheon
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Ajou University Hospital
NOT_YET_RECRUITING
Suwon
Romania
Institutul National de Endocrinologie C. I. Parhon
NOT_YET_RECRUITING
Bucharest
National University Hospital for Children's Neurorehabilitation Dr. Nicolae Robanescu
NOT_YET_RECRUITING
Bucharest
Spitalul Clinic de Urgenta Sfantul Spiridon
NOT_YET_RECRUITING
Iași
Spain
Hospital Universitario Vall d'Hebron - PPDS
NOT_YET_RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Corporacio Sanitaria Parc Tauli
NOT_YET_RECRUITING
Sabadell
United Kingdom
Fulborn Hospital
NOT_YET_RECRUITING
Cambridge
Royal Hospital for Children (Glasgow) - PPDS - PIN
NOT_YET_RECRUITING
Glasgow
Leicester Royal Infirmary
NOT_YET_RECRUITING
Leicester
The Royal London Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Robin Schmidt, MS
Info@AardvarkTherapeutics.com
(858) 225-7696
Time Frame
Start Date: 2024-12-20
Estimated Completion Date: 2026-04
Participants
Target number of participants: 90
Treatments
Experimental: Treatment Arm A
ARD-101
Placebo_comparator: Treatment Arm B
Placebo for ARD-101
Related Therapeutic Areas
Sponsors
Leads: Aardvark Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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