Prader-Willi Syndrome Clinical Trial
— PWSOfficial title:
A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi Syndrome
Verified date | December 2022 |
Source | Saniona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 9, 2022 |
Est. primary completion date | December 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 65 Years |
Eligibility | Key Inclusion Criteria: - Subject and their legally authorized representative must be willing to provide informed consent - Confirmed genetic diagnosis of PWS - Body mass index (BMI) within the following range at Screening: 1. Female and male subjects 18 to 65 years of age: 27 to 60 kg/m2; or 2. Female and male subjects 13 to 17 years of age with BMI that is at least 85th percentile for age and sex; - Female subjects must be of non-child-bearing potential - Documented stable body weight - Moderate hyperphagia at Screening and at Baseline - Participants must have a reliable and stable caregiver who should be able to spend an adequate amount of time with the participants to be able to address behaviors, activities and symptoms - Male subjects who are sexually active must be surgically sterile Key Exclusion Criteria: - Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study - Sitting BP that meets the following criteria after 5 minutes of rest at Screening: 1. Adult subjects with systolic BP >/=145 mmHg or <100 mmHg; or 2. Adult subjects with diastolic BP >/=95 mmHg or <70 mmHg; or 3. Adolescent subjects with a systolic or diastolic BP that is 95th percentile or greater for age and sex - Type 1 diabetes mellitus - History of dementia (eg, Alzheimer's disease, Parkinson's disease) - History of bulimia or anorexia nervosa - History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder), or symptoms of delusions, hallucinations, or mania/hypomania within 90 days prior to Screening, as described by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) - Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism) - Medical condition or recent systemic infection that, in the opinion of the Investigator, could impact the safety of the subject - Use of prohibited medications, including current use of SSRIs/SNRIs |
Country | Name | City | State |
---|---|---|---|
United States | Sparrow Clinical Research Institute | Lansing | Michigan |
Lead Sponsor | Collaborator |
---|---|
Saniona |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hyperphagia | Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score | Baseline to Week 16 | |
Secondary | Change in Body Weight | Percentage change in body weight | Baseline to Week 16 | |
Secondary | Hyperphagia Severity (Caregiver) | Change in caregiver rating of hyperphagia severity | Baseline to Week 16 | |
Secondary | Hyperphagia Change (Caregiver) | Proportion of caregiver responses for change in subject's hyperphagia | Week 16 | |
Secondary | PWS Severity (Clinician) | Change in clinician rating of the subject's PWS severity | Baseline to Week 16 | |
Secondary | Overall Status Change (Clinician) | Proportion of clinician responses for change in subject's overall clinical status | Week 16 |
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