Feasibility Pilot for the ReBOO-trial

Study Overview
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Brief Summary
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This is a pilot testing the feasibility of the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' trial (ReBOO-trial). The full-scale ReBOO will further investigate safety and efficacy of intragastric injections of botulinum toxin A into the antrum area of the stomach. These injections will be repeated every six months. The study sample will be adolescents with obesity who have not responded to standard conservative treatment.

Official Title
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A Non-randomised, Open Feasibility Pilot for the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' (ReBOO) Trial

Conditions
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Obesity

Intervention / Treatment
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* Drug: Intragastric botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written (signed) informed consent Age and gender adjusted body mass index (ISO-BMI) ≥ 35 or ISO-BMI > 30 with comorbidities including hypertension, non-alcoholic fatty liver disease, hyperlipidemia or impaired glucose tolerance Having partaken in a comprehensive multi-disciplinary lifestyle treatment for obesity of duration 12 months or more, without achieving a clinically significant weight loss (non-responder) Exclusion Criteria: Known hypersensitivity to excipients in the investigational medicine product (IMP) Neuromuscular disorders History of dysphagia History of aspiration tendency or aspiration pneumonia Known lung disease under continuous treatment Congenital or acquired heart disease Previous experience of side effects to Botulinum toxin type A Present gastric diseases or dysfunction Previous bariatric surgery History of cancer Serious binge eating disorder Untreated hypothyroidism Use of aminoglycoside antibiotics or spectinomycin in the week prior to injection, or any other medicinal product that interfere with neuromuscular transmission (neuromuscular blocking agents) Medication known to affect appetite Syndromic obesity Mentally immature to a degree that there is doubt about the subject's ability to assent Issues relating to language or culture that may complicate trial participation Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intragastric botulinum toxin type A<br>Botulinum toxin A (Allergan) injected intragastrically in the antrum | Drug: Intragastric botulinum toxin type A<br>* 200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months<br>* Other names: Allergan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Proportion of participants reaching a reduction in BMI z-score equal to or more than 1 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection interval | Patient reports will indicate the appropriate re-injection interval | 12 months | 
| Patient adherence to treatment | Qualitative data based on interviews with patients and next of kin. | 12 months | 
| Incidence of treatment-emergent adverse events | All adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) will be evaluated | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Injections, intraperitoneal, Endoscopy, Botulinum Toxins, Type A, OnabotulinumtoxinA