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Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)

NCT03149445 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-02-26

Study results available
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Summary

Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study followed by two open label extension periods.

Conditions

  • Confirmed Genetic Diagnosis of Prader-Willi Syndrome

Interventions

DRUG

Tesofensine/Metoprolol

Study medication will be administered for 91 days.

DRUG

Placebos

Study medication will be administered for 91 days.

Sponsors & Collaborators

  • Saniona

    lead INDUSTRY

Principal Investigators

  • Kim Krogsgaard, MD, DMSc · Saniona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2019-07-22
Completion
2019-07-22

Countries

  • Czechia
  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03149445 on ClinicalTrials.gov