ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

December 20, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

April 30, 2026

Conditions
HyperphagiaPrader-Willi Syndrome
Interventions
DRUG

Placebo

200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks

DRUG

ARD-101

200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks

Trial Locations (44)

50

NOT_YET_RECRUITING

Ospedale Pediatrico Bambino Gesù IRCCS, Rome

2050

RECRUITING

Royal Prince Alfred Hospital, Camperdown

2145

NOT_YET_RECRUITING

The Children's Hospital at Westmead, Westmead

4101

RECRUITING

Queensland Children's Hospital, South Brisbane

8035

NOT_YET_RECRUITING

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

8208

NOT_YET_RECRUITING

Corporacio Sanitaria Parc Tauli, Sabadell

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

NOT_YET_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

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

RECRUITING

Cook Children's Medical Center, Fort Worth

92024

RECRUITING

Rady Children's Hospital, Encinitas

92868

NOT_YET_RECRUITING

Children's Hospital of Orange Country, Orange

94304

RECRUITING

Stanford Childrens Health Specialty Services, Palo Alto

98105

RECRUITING

Seattle Children's Hospital, Seattle

700125

NOT_YET_RECRUITING

Spitalul Clinic de Urgenta Sfantul Spiridon, Iași

35233-1711

RECRUITING

Children's of Alabama, Birmingham

80045-7106

RECRUITING

Childrens Hospital Colorado, Denver

19803-3607

RECRUITING

Nemours Children Clinic Wilmington, Wilmington

32610-3008

RECRUITING

UF Shands Childrens Hospital, Gainesville

30322-1047

RECRUITING

Emory University School of Medicine, Atlanta

60611-2991

NOT_YET_RECRUITING

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago

21287-0005

NOT_YET_RECRUITING

The Johns Hopkins Hospital, Baltimore

11219-2918

RECRUITING

Maimonides Medical Center, Brooklyn

11501-4077

RECRUITING

NYU Langone Children's Ambulatory Care Center, Mineola

37232-0005

RECRUITING

Vanderbilt University Medical Center, Nashville

78596-7288

WITHDRAWN

Texas Valley Clinical Research, LLC, Weslaco

T3B 6A8

NOT_YET_RECRUITING

Alberta Children's Hospital Research Institute, Calgary

T6G 2B7

NOT_YET_RECRUITING

Li Ka Shing Centre for Health Research Innovation, Edmonton

H3T 1C5

NOT_YET_RECRUITING

Centre Hospitalier Universitaire Sainte-Justine, Montreal

06351

NOT_YET_RECRUITING

Samsung Medical Center, Seoul

LE1 5WW

NOT_YET_RECRUITING

Leicester Royal Infirmary, Leicester

CB21 5EF

NOT_YET_RECRUITING

Fulborn Hospital, Cambridge

G51 4TF

NOT_YET_RECRUITING

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

E1 4NS

NOT_YET_RECRUITING

The Royal London Hospital, London

Sponsors
All Listed Sponsors
lead

Aardvark Therapeutics, Inc.

INDUSTRY