search
Back to results

Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS) (2016-003694-18)

Primary Purpose

Confirmed Genetic Diagnosis of Prader-Willi Syndrome

Status
Completed
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
Tesofensine/Metoprolol
Placebos
Sponsored by
Saniona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Confirmed Genetic Diagnosis of Prader-Willi Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females
  2. Confirmed genetic diagnosis of Prader-Willi syndrome
  3. Age: Step 1: Adults aged 18-30 b. Step 2: Children aged 12-17

  4. BMI:

    1. Step 1: Adults with ≥25 kg/m2
    2. Step 2: Children with a BMI >85th percentile for the same age and sex
  5. Normal BP or well managed hypertension (only if dose of BP medication(s) has been stable for >2 months)
  6. Normal lipid profile or well managed dyslipidemia (only if dose of lipid-lowering medication(s) has been stable for >2 months)
  7. On stable dose of growth hormone >2 months

Exclusion Criteria:

  1. Hypersensitivity to tesofensine/metoprolol
  2. Type 1 diabetes
  3. Heart failure NYHA level II or greater, decompensated heart failure
  4. Previous myocardial infarction or stroke
  5. Diagnosis of schizophrenia, bipolar disorder, personality disorder or other DSM-III disorders, which in the investigator's opinion will interfere significantly with study compliance

Sites / Locations

  • Hospital Motol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tesofensine/Metoprolol

Tesofensine/Metoprolol placebo

Arm Description

Tesofensine + metoprolol administered once a day, in the morning with a meal

Placebo tablets matching tesofensine + metoprolol administered once a day, in the morning with meal

Outcomes

Primary Outcome Measures

Change from baseline on body weight in subjects with PWS
To examine the effect of co-administration of tesofensine/metoprolol on body weight in subjects with PWS

Secondary Outcome Measures

Full Information

First Posted
April 3, 2017
Last Updated
April 21, 2020
Sponsor
Saniona
search

1. Study Identification

Unique Protocol Identification Number
NCT03149445
Brief Title
Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)
Acronym
2016-003694-18
Official Title
A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Multi-centre Safety and Efficacy Study of Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saniona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.
Detailed Description
Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study. Study medication will be administered for 91 days. The study will be conducted in two steps: Step 1 - 10-15 adult subjects with PWS will be treated. DSMB review and SUKL review - following the completion of the treatment of the adult subjects, unblinded efficacy, safety, PK data as well as all data from the study in subjects with type 2 diabetes (TM001) will be reviewed by an independent Data Safety Monitoring Board (DSMB) and State Institute for Drug Control (SUKL). Following the SUKL's approval the study will proceed to: Step 2 - 10-15 children with PWS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Confirmed Genetic Diagnosis of Prader-Willi Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tesofensine/Metoprolol
Arm Type
Experimental
Arm Description
Tesofensine + metoprolol administered once a day, in the morning with a meal
Arm Title
Tesofensine/Metoprolol placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching tesofensine + metoprolol administered once a day, in the morning with meal
Intervention Type
Drug
Intervention Name(s)
Tesofensine/Metoprolol
Other Intervention Name(s)
Tesofensine, Metoprolol
Intervention Description
Study medication will be administered for 91 days.
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Placebo
Intervention Description
Study medication will be administered for 91 days.
Primary Outcome Measure Information:
Title
Change from baseline on body weight in subjects with PWS
Description
To examine the effect of co-administration of tesofensine/metoprolol on body weight in subjects with PWS
Time Frame
0-91 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females Confirmed genetic diagnosis of Prader-Willi syndrome Age: Step 1: Adults aged 18-30 b. Step 2: Children aged 12-17 BMI: Step 1: Adults with ≥25 kg/m2 Step 2: Children with a BMI >85th percentile for the same age and sex Normal BP or well managed hypertension (only if dose of BP medication(s) has been stable for >2 months) Normal lipid profile or well managed dyslipidemia (only if dose of lipid-lowering medication(s) has been stable for >2 months) On stable dose of growth hormone >2 months Exclusion Criteria: Hypersensitivity to tesofensine/metoprolol Type 1 diabetes Heart failure NYHA level II or greater, decompensated heart failure Previous myocardial infarction or stroke Diagnosis of schizophrenia, bipolar disorder, personality disorder or other DSM-III disorders, which in the investigator's opinion will interfere significantly with study compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Krogsgaard, MD, DMSc
Organizational Affiliation
Saniona
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Motol
City
Prague
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs