Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome
NCT05198362 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2022-12-13
Summary
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.
Conditions
Interventions
- OTHER
-
Placebo
Inactive comparator
- DRUG
-
Tesomet
Fixed-dose combination
Sponsors & Collaborators
-
Saniona
lead INDUSTRY
Principal Investigators
-
Sophie Guillaume, MS · Saniona
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-28
- Primary Completion
- 2022-12-09
- Completion
- 2022-12-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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