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

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ClinicalTrials.gov Identifier: NCT03149445
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Saniona

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019


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.

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.




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



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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

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


Contacts
Contact: Jorgen Drejer, PhD +45 20289705 jd@saniona.com

Locations
Czechia
Hospital Motol Recruiting
Prague, Czechia
Contact: Stanislava Kolouskova, Dr. med.         
Contact       stanislava.kolouskova@lfmotol.cuni.cz   
Sponsors and Collaborators
Saniona

Responsible Party: Saniona
ClinicalTrials.gov Identifier: NCT03149445     History of Changes
Other Study ID Numbers: TM002
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Prader-Willi Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
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