The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

July 23, 2024

Primary Completion Date

March 31, 2027

Study Completion Date

April 30, 2027

Conditions
HyperphagiaPrader-Willi SyndromeHyperphagia in Prader-Willi Syndrome
Interventions
DRUG

ARD-101

200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks

Trial Locations (36)

2145

NOT_YET_RECRUITING

The Children's Hospital at Westmead, Westmead

4101

NOT_YET_RECRUITING

Queensland Children's Hospital, South Brisbane

11852

NOT_YET_RECRUITING

Institutul National de Endocrinologie C. I. Parhon, Bucharest

16499

NOT_YET_RECRUITING

Ajou University Hospital, Suwon

20132

NOT_YET_RECRUITING

Ospedale San Raffaele S.r.l. - PPDS, Milan

22332

NOT_YET_RECRUITING

Inha University Hospital, Incheon

28041

NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre, Madrid

31059

NOT_YET_RECRUITING

CHU de Toulouse- Hôpital de Rangueil, Toulouse

31300

NOT_YET_RECRUITING

CHU de Toulouse-Hôpital Des Enfants, Toulouse

41408

RECRUITING

"National University Hospital for Children's Neurorehabilitation Dr. Nicolae Robanescu", Bucharest

49933

NOT_YET_RECRUITING

CHU d'Angers, Angers

50139

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN, Florence

55102

NOT_YET_RECRUITING

University of Minnesota Masonic Children's Hospital, Minneapolis

75013

NOT_YET_RECRUITING

AP-HP - Hôpital de la Pitié Salpétrière, Paris

75015

NOT_YET_RECRUITING

AP-HP - Hôpital universitaire Necker-Enfants malades, Paris

76104

NOT_YET_RECRUITING

Cook Children's Medical Center, Fort Worth

92024

NOT_YET_RECRUITING

Rady Children's Hospital, San Diego

94304

NOT_YET_RECRUITING

Stanford Children's Health Specialty Services, Palo Alto

98105

NOT_YET_RECRUITING

Seattle Children's Hospital, Seattle

700125

NOT_YET_RECRUITING

Spitalul Clinic de Urgenta Sfantul Spiridon, Iași

35233-1711

NOT_YET_RECRUITING

Children's of Alabama, Birmingham

80045-7106

NOT_YET_RECRUITING

Children's Hospital Colorado, Denver

19803-3607

NOT_YET_RECRUITING

Nemours Children's Clinic Wilmington, Wilmington

32610-3008

NOT_YET_RECRUITING

UF Shands Children's Hospital, Gainesville

30322-1047

NOT_YET_RECRUITING

Emory University School of Medicine, Atlanta

11219-2918

NOT_YET_RECRUITING

Maimonides Medical Center, Brooklyn

11501-4077

RECRUITING

NYU Langone Children's Ambulatory Care Center, Mineola

37232-0005

NOT_YET_RECRUITING

Vanderbilt University Medical Center, Nashville

00165

NOT_YET_RECRUITING

Ospedale Pediatrico Bambino Gesù IRCCS, Rome

06351

NOT_YET_RECRUITING

Samsung Medical Center, Seoul

08208

NOT_YET_RECRUITING

Corporacio Sanitaria Parc Tauli, Sabadell

08035

NOT_YET_RECRUITING

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

CB21 5EF

NOT_YET_RECRUITING

Fulborn Hospital, Cambridge

G51 4TF

NOT_YET_RECRUITING

Royal Hospital for Children (Glasgow) - PPDS - PIN, Glasgow

LE1 5WW

NOT_YET_RECRUITING

Leicester Royal Infirmary, Leicester

E1 1BB

NOT_YET_RECRUITING

The Royal London Hospital, London

Sponsors
All Listed Sponsors
lead

Aardvark Therapeutics, Inc.

INDUSTRY