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

2017-05-12 13:38:21 | BioPortfolio

Summary

Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.

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

Conditions

Confirmed Genetic Diagnosis of Prader-Willi Syndrome

Intervention

Tesofensine/Metoprolol, Placebos

Location

Hospital Motol
Prague
Czechia

Status

Recruiting

Source

Saniona

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-05-12T13:38:21-0400

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Medical and Biotech [MESH] Definitions

An autosomal dominant disorder caused by deletion of the proximal long arm of the paternal chromosome 15 (15q11-q13) or by inheritance of both of the pair of chromosomes 15 from the mother (UNIPARENTAL DISOMY) which are imprinted (GENETIC IMPRINTING) and hence silenced. Clinical manifestations include MENTAL RETARDATION; MUSCULAR HYPOTONIA; HYPERPHAGIA; OBESITY; short stature; HYPOGONADISM; STRABISMUS; and HYPERSOMNOLENCE. (Menkes, Textbook of Child Neurology, 5th ed, p229)

Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.

Production of new arrangements of DNA by various mechanisms such as assortment and segregation, CROSSING OVER; GENE CONVERSION; GENETIC TRANSFORMATION; GENETIC CONJUGATION; GENETIC TRANSDUCTION; or mixed infection of viruses.

The fundamental tenet of modern medicine that certain diseases are caused by microorganisms. It was confirmed by the work of Pasteur, Lister, and Koch.

The discipline studying genetic composition of populations and effects of factors such as GENETIC SELECTION, population size, MUTATION, migration, and GENETIC DRIFT on the frequencies of various GENOTYPES and PHENOTYPES using a variety of GENETIC TECHNIQUES.

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