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Prader-Willi Syndrome TEMPO

Status: Open to Enrollment
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Study details

View study details on clinicaltrials.gov.

Locations

  • Sacramento

Clinical trial FAQs

Information for patients and study volunteers, including frequently asked questions.

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.
Gnanagurudasan Prakasam, M.D.
Principal investigator
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Sub-Investigator

Ulhas M Nadgir, M.D.

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