We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149445
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Saniona

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.

Condition or disease Intervention/treatment Phase
Confirmed Genetic Diagnosis of Prader-Willi Syndrome Drug: Tesofensine/Metoprolol Drug: Placebos Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
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)
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : January 4, 2019
Actual Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Tesofensine/Metoprolol
Tesofensine + metoprolol administered once a day, in the morning with a meal
 Drug: Tesofensine/Metoprolol
Study medication will be administered for 91 days.
Other Names:
  • Tesofensine
  • Metoprolol
Placebo Comparator: Tesofensine/Metoprolol placebo
Placebo tablets matching tesofensine + metoprolol administered once a day, in the morning with meal
 Drug: Placebos
Study medication will be administered for 91 days.
Other Name: Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change from baseline on body weight in subjects with PWS [ Time Frame: 0-91 days ]
    To examine the effect of co-administration of tesofensine/metoprolol on body weight in subjects with PWS


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149445


Locations
Layout table for location information
Czechia
Hospital Motol
Prague, Czechia
Sponsors and Collaborators
Saniona
Investigators
Layout table for investigator information
Study Director: Kim Krogsgaard, MD, DMSc Saniona
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Saniona
ClinicalTrials.gov Identifier: NCT03149445    
Other Study ID Numbers: TM002
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action