--- title: "Prader-Willi Syndrome TEMPO | Sutter Health" description: "A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients with Prader-Willi Syndrome" url: "https://www.sutterhealth.org/research/clinical-trials/prader-willi-syndrome-tempo-1095733969" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Clinical trials](https://www.sutterhealth.org/research/clinical-trials) / 4. Prader-Willi Syndrome TEMPO # Prader-Willi Syndrome TEMPO **Status:** Open to Enrollment [Email us to enroll](https://www.sutterhealth.org/research/clinical-trials/prader-willi-syndrome-tempo-1095733969#enroll) #### Study details View study details on [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06366464). #### Locations - Sacramento #### Clinical trial FAQs Information for patients and study volunteers, including [frequently asked questions](https://www.sutterhealth.org/research/faqs). This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives include assessing the impact of pitolisant on: - Irritable and disruptive behaviors - Hyperphagia - Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech ![Gnanagurudasan Prakasam, M.D.](https://dyn.mktgcdn.com/p/KZGsi4wXLoBlX4kBmYnknAZObscPAn1UC-XvgSdnKIY/fit=crop,gravity=auto,dpr=2,width=188,height=250,quality=100) Gnanagurudasan Prakasam, M.D. Principal investigator [View profile](https://www.sutterhealth.org/research/investigators/gnanagurudasan-prakasam-md-1049681012) ## Sub-Investigator [Ulhas M Nadgir, M.D.](https://www.sutterhealth.org/research/investigators/ulhas-m-nadgir-md-2011875488) ## Email us to enroll - [Email Sacramento](mailto:ClinicalResearch%40sutterhealth.org?subject=More%20information%20on%20Prader-Willi%20Syndrome%20TEMPO%20in%20Sacramento&body=Please%20be%20aware%20that%20if%20you%20reply%20with%20unencrypted%20email%2C%20this%20increases%20the%20risk%20that%20information%20could%20be%20read%20by%20an%20unauthorized%20third%20party.%20Please%20do%20not%20include%20any%20Protected%20Health%20Information%20in%20your%20email%20response.) ## Related clinical trials [View all clinical trials](https://www.sutterhealth.org/research-search-results?verticalKey=clinical_trial) - 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