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Now Enrolling: Participate in the TEMPO PWS Study Without Leaving Home

Families can now join the TEMPO PWS clinical trial from home—exploring pitolisant as a treatment for excessive daytime sleepiness in PWS.

Now Enrolling - Participate in the TEMPO PWS Study Without Leaving HomeWe’re excited to share a new opportunity to take part in the TEMPO clinical trial—from the comfort of your own home! Harmony Biosciences has launched a 100% virtual site for the TEMPO study of pitolisant in individuals with Prader-Willi syndrome (PWS). This innovative at-home option makes it easier than ever to join important research, especially for families where travel can be difficult.

What Is the TEMPO Study?

The TEMPO study is a clinical trial evaluating whether pitolisant, a once-daily medication, can help manage excessive daytime sleepiness and other behavioral symptoms associated with PWS. The trial includes a 22-week double-blind study with an optional 52-week open-label extension.

A Convenient At-Home Option

The new TEMPO At-Home site—managed by Science 37, a leader in virtual clinical trials—offers a fully remote experience for families:

  • No travel required

  • Flexible scheduling

  • Study drug shipped directly to your home

  • In-home visits from a clinical study nurse

  • Virtual check-ins with the study team

  • No disruption to your current medical care

Whether you’re in a rural area, have limited access to study sites, or simply prefer the convenience of participating from home, this option makes it easier to contribute to important research.

What to Expect

If your loved one qualifies and you choose to participate in both phases of the study, participation includes:

  • Up to 8 nurse visits in your home

  • Up to 5 virtual visits

  • Blood and urine samples and ECGs collected at in-home visits

  • Use of an app to complete caregiver questionnaires and diaries

All study-related medication and materials are delivered directly to your home. Throughout the study, your current doctor will remain involved in your loved one’s care and will receive updates from the study team.

TEMPO AT HOME

Who Can Participate?

Your loved one may be eligible if they:

  • Are 6 years or older

  • Have a confirmed PWS diagnosis

  • Live in the United States

  • Experience excessive daytime sleepiness

  • Have a consistent caregiver throughout the study

Learn More 

Visit tempopwsstudy.com to learn more about the study and see if it’s a good fit for your family.

You can also reach out to the at-home study team directly:

📧 Email: HarmonyPWS@science37.com
📞 Phone: 310-929-8473

This at-home opportunity reflects a growing movement toward flexible, family-centered research. We’re grateful to Harmony Biosciences and Science 37 for reducing barriers to participation and making it easier for our community to be part of the future of PWS treatment.

PWS Clinical Trials

Topics: Clinical Trials Opportunities

Susan Hedstrom

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Susan Hedstrom is the Executive Director for the Foundation for Prader-Willi Research. Passionate about finding treatments for PWS, Susan joined FPWR in 2009 shortly after her son, Jayden, was diagnosed with Prader-Willi Syndrome. Rather than accepting PWS as it has been defined, Susan has chosen to work with a team of pro-active and tireless individuals to accelerate PWS research in order to change the future of PWS. Inspired by her first FPWR conference and the team of researchers that were working to find answers for the syndrome, she joined the FPWR team in 2010 and led the development of the One SMALL Step walk program. Under Susan’s leadership, over $15 million has been raised for PWS related research.