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Foundation for Prader-Willi Blog | Clinical Trials (2)

Harmony Biosciences Initiates Global Phase 3 Study of Pitolisant: TEMPO!

Harmony Biosciences has initiated its Phase 3 study of Pitolisant and is now enrolling individuals with Prader-Willi syndrome ages 6 and up who struggle with excessive daytime sleepiness. Two clinical trial sites are already open and ready to begin s...

Topics: Clinical Trials

VNS4PWS Clinical Trial Opens for Enrollment

The Foundation for Prader-Willi Research is pleased to announce our VNS4PWS clinical trial is now open and enrolling participants with PWS ages 10-40 who experience disruptive behaviors and temper outbursts.

Topics: Research, Clinical Trials

Acadia Initiates Phase 3 COMPASS PWS Study of Carbetocin

Acadia Pharmaceuticals has initiated its pivotal Phase 3 COMPASS PWS study of carbetocin nasal spray (ACP-101) in the United States. COMPASS PWS is a 12-week study evaluating the efficacy and safety of carbetocin nasal spray for hyperphagia in approx...

Topics: Clinical Trials

Soleno Therapeutics Announces Positive Statistically Significant Top-line Results from Randomized Withdrawal Period of Study C602 of DCCR for Prader-Willi Syndrome

We are excited to share the news that Soleno has announced positive, statistically significant top-line results from the randomized withdrawal period of study c602 of DCCR for Prader-Willi Syndrome. In the study, patients taking DCCR showed a highly ...

Topics: News, Clinical Trials

Aardvark Announces Rare Disease Designation and Expands Ongoing Phase 2 Trial

Aardvark Therapeutics, a clinical stage biopharmaceutical company, has reported receipt of a Rare Pediatric Disease Designation in Prader-Willi Syndrome (PWS) from the FDA for its lead program ARD-101.

Topics: News, Clinical Trials

Harmony Biosciences Announces Phase 3 Study of Pitolisant

Harmony Biosciences has announced plans to begin a Phase 3 study of Pitolisant for individuals with Prader-Willi syndrome ages 6 and up in the 4th quarter of 2023. This announcement is made following a positive end-of-phase 2 meeting with the FDA. Ha...

Topics: Clinical Trials

PWS Clinical Trials Panel [2022 CONFERENCE VIDEO]

In this 1-hour and 7-minute video, FPWR Executive Director Susan Hedstrom presents an overview of current and upcoming PWS clinical trials, and trial representatives provide brief presentations on specific trials.

Topics: Clinical Trials, Family Conference

What Can I Expect if I Participate in the KITE-PWS Clinical Trial?

KITE-PWS is an ongoing Phase II trial of RGH-706 for people with PWS ages 17 and up. The study is sponsored by Gedeon Richter, a Hungarian-based company with 120 years of drug development experience. They have produced more than 200 drugs in over 40 ...

Topics: Clinical Trials

Acadia Announces Phase 3 Study of ACP-101 (Intranasal Carbetocin)

Acadia Pharmaceuticals has announced the addition of a new Phase 3 development candidate to its rare disease portfolio, ACP-101 (intranasal carbetocin), for the treatment of hyperphagia in Prader-Willi syndrome (PWS).

Topics: Clinical Trials