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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 1 February 2020
Main ID:  EUCTR2016-003694-18-CZ
Date of registration: 04/10/2016
Prospective Registration: Yes
Primary sponsor: Saniona A/S
Public title: Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndrome
Scientific 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) "Second 12 weeks open label extension"
Date of first enrolment: 18/01/2017
Target sample size: 35
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003694-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Czech Republic Hungary
Contacts
Name: Clinical & Regulatory department   
Address:  Baltorpvej 154 DK 2750 Ballerup Denmark
Telephone: +4520289705
Email: jd@saniona.com
Affiliation:  Saniona A/S
Name: Clinical & Regulatory department   
Address:  Baltorpvej 154 DK 2750 Ballerup Denmark
Telephone: +4520289705
Email: jd@saniona.com
Affiliation:  Saniona A/S
Key inclusion & exclusion criteria
Inclusion criteria:
All male and female pediatric subjects with confirmed diagnosis of PWS who completed the double blind phase (12 weeks) and the first OLE, will be invited to participate in the second open label 12 weeks extension phase, if deemed eligible by the Investigators.
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
If subject/parents decide to not participate in OLE II, subject will finish the study based on the Protocol Amendment 1.6.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Prader Willi syndrome (PWS)
MedDRA version: 20.0 Level: PT Classification code 10036476 Term: Prader-Willi syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Intervention(s)

Product Name: Tesofensine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tesofensine
CAS Number: 195875-86-6
Current Sponsor code: NS2330
Other descriptive name: TESOFENSINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-

Trade Name: Metoprololsuccinat ”Orion” 25mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: metoprolol
Other descriptive name: METOPROLOL SUCCINATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 23750-

Primary Outcome(s)
Main Objective: The purpose of this study is to investigate the safety and efficacy of co-administration of tesofensine/metoprolol treatment versus placebo in adult and pediatric subjects with Prader-Willi syndrome. The primary objective is to examine the effect of co-administration of tesofensine/metoprolol on body weight in subjects with PWS in an open
labeled extension study.
Primary end point(s): The primary endpoint for this study is percent change from baseline to end of treatment periods in mean body weight.
Secondary Objective: The secondary objectives are:
1. To establish pharmacokinetic profile of tesofensine and metoprolol in subjects with PWS
2. To examine the change in hyperphagia-related behaviour in subjects with PWS by use of the Hyperphagia Questionnaire for Clinical Trials (HQ-CT)
3. To examine the effect of co-administration of tesofensine/metoprolol on glycaemic control and lipid profile in subjects with PWS
4. To examine the effect of co-administration of tesofensine/metoprolol on HR and BP in subjects with PWS
5. To examine the effects of co-administration of tesofensine/metoprolol on body composition in subjects with PWS
6. To evaluate overall safety and tolerability of co-administration of the tesofensine/metoprolol in subjects with PWS
Timepoint(s) of evaluation of this end point: Day 90, Day 180, Day 270
Secondary Outcome(s)
Secondary end point(s): Secondary endpoints include:
1. Steady state concentrations of tesofensine and metoprolol as measured by trough values
2. Uptake and initial plateau concentrations of metoprolol as measured
by samples taken 2 and 4 hours after dose administration
3. Change from baseline to end of the treatment periods in total HQCT score
4. Change from baseline to end of treatment periods in mean body weight (kg)
5. Change from baseline to end of treatment periods in fat- and fat-free mass (%) by dual X-ray absorptiometry (DXA)
6. Change from baseline to end of treatment periods in HR (bpm), SBP (mmHg), DBP (mmHg)
7. AEs, clinical labs, ECG
There are additional exploratory endpoints:
1. Change from baseline to end of treatment periods in FPG, insulin
2. Change from baseline to end of treatment periods in lipid profile
3. Change from baseline to end of treatment periods in waist circumference (cm)
Timepoint(s) of evaluation of this end point: From baseline to end of study treatment.
Secondary ID(s)
n.a.
TM002
Source(s) of Monetary Support
Saniona A/S
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 04/01/2017
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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