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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

Tracking Information
First Submitted Date  ICMJE April 3, 2017
First Posted Date  ICMJE May 11, 2017
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE March 30, 2017
Actual Primary Completion Date January 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Confirmed Genetic Diagnosis of Prader-Willi Syndrome
Intervention  ICMJE
  • Drug: Tesofensine/Metoprolol
    Study medication will be administered for 91 days.
    Other Names:
    • Tesofensine
    • Metoprolol
  • Drug: Placebos
    Study medication will be administered for 91 days.
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Tesofensine/Metoprolol
    Tesofensine + metoprolol administered once a day, in the morning with a meal
    Intervention: Drug: Tesofensine/Metoprolol
  • Placebo Comparator: Tesofensine/Metoprolol placebo
    Placebo tablets matching tesofensine + metoprolol administered once a day, in the morning with meal
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2020)
18
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2017)
15
Actual Study Completion Date  ICMJE June 17, 2019
Actual Primary Completion Date January 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03149445
Other Study ID Numbers  ICMJE TM002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Saniona
Study Sponsor  ICMJE Saniona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kim Krogsgaard, MD, DMSc Saniona
PRS Account Saniona
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP