A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome
NCT05153434 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2025-05-09
Summary
A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome
Conditions
Interventions
- DRUG
-
ARD-101
Twice Daily, Oral Administration
Sponsors & Collaborators
-
Children's Hospital Colorado
collaborator OTHER - collaborator OTHER
-
Aardvark Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 17 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-27
- Primary Completion
- 2024-09-24
- Completion
- 2024-09-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of CSTI-500 in Patients With Prader-Willi Syndrome
NCT07348601 ·Status: RECRUITING ·Phase: PHASE2
-
Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial
NCT05032326 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of Pitolisant in Participants With Prader-Willi Syndrome
NCT07219485 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE3
-
Phase II Pilot Study of Aminoimidazole Carboxamide Riboside (AICAR), a Precursor of Purine Synthesis, for Lesch-Nyhan Disease
NCT00004314 ·Status: COMPLETED ·Phase: PHASE2
-
An Open Label Extension Study in Subjects With Fragile X Syndrome
NCT01555333 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome
NCT07281079 ·Status: RECRUITING ·Phase: PHASE3
-
Natural History Study of Serious Medical Events in PWS
NCT03718416 ·Status: COMPLETED
-
An Open-Label Study of Oral NNZ-2591 in Pitt Hopkins Syndrome (PTHS-001)
NCT05025332 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy
NCT03570931 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome
NCT03882918 ·Status: TERMINATED ·Phase: PHASE3
-
A Study With RO4917523 in Patients With Fragile X Syndrome
NCT01015430 ·Status: COMPLETED ·Phase: PHASE2
-
A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Female Participants With Fabry Disease
NCT00304512 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome
NCT03458416 ·Status: TERMINATED ·Phase: PHASE2
-
An Open-Label Study of Oral NNZ-2591 in Phelan-McDermid Syndrome (PMS-001)
NCT05025241 ·Status: COMPLETED ·Phase: PHASE2
-
TPN-101 in Aicardi-Goutières Syndrome (AGS)
NCT05613868 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome
NCT01325740 ·Status: SUSPENDED ·Phase: PHASE2
-
A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome
NCT05504395 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome
NCT01750957 ·Status: COMPLETED ·Phase: PHASE2
-
A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
NCT00965432 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
NCT00002127 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome
NCT05098509 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome
NCT00420459 ·Status: COMPLETED ·Phase: PHASE2
-
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of Oral NNZ-2591 in Angelman Syndrome
NCT05011851 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, PK and PD of FLQ-101 in Premature Neonates
NCT07093255 ·Status: RECRUITING ·Phase: PHASE1
-
Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU)
NCT04085666 ·Status: COMPLETED ·Phase: PHASE1