Treatment of obesity in adolescents through stomach injections of botox

Phase 1

Conditions: Obesity
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2016-000326-19-NO

Lead Sponsor: St Olavs Hospital Trondheim University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 140

Inclusion Criteria

adolesent (12-18 years), BMI or ISO-BMI > 35, not having achieved a clinically important, sustainable weight loss in a comprehensive multi-disciplinary lifestyle programme for obesity
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
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

Known hypersensitivity to excipients in IMP, neuromuscular disorders, history of disphagia, history of aspiration tendency or aspiration pneumonia, known lung disease under continuous treatment, congenital of acquired heart disease, previous experience of side effects for injections of BTA, present gastric diseases of dysfunction, previous experience of side effects for BTxA, previous bariatric surgery, history of cancer, serious binge eating disorder, untreated hyperthyroidism, use of aminoglycoside antibiotics or spectinomycin last week, use of any other medicinal products that interfere with neuromuscular transmission (neuromuscular blocking agents), medication known to affect appetite, syndromal obesity, mentally immature to the degree that there is doubt about the subject's ability to consent, issues related to language and culture that may complicate trial participation, pregnant or lactating women.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.The study aims to detect a difference in proportions of treatment responders between the Botox group and placebo group of at least 25%.<br>2.Safety.<br>;Secondary Objective: Secondary:<br>1.Biological and psychological markers<br>2.Economic evaluation<br>3.Patients’ views and experiences<br>;Primary end point(s): Body weight (ISO-BMI);Timepoint(s) of evaluation of this end point: Baseline, 12 months, 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Laboratory: Hb, HbA1c, glucose, C-peptide, Na, K, creatinine, HDL, LDL, total cholesterol, triglycerids, HS-CRP, ALAT.<br>Clinical tests: Blood pressure<br>Anthropometry: Height, weight, BodPod (body composition);Timepoint(s) of evaluation of this end point: Baseline, 12 months, 24 months