Feasibility Pilot for the ReBOO-trial

St. Olavs Hospital10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Intragastric botulinum toxin type ADRUG

200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written (signed) informed consent 2. 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 3. 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: 1. Known hypersensitivity to excipients in the investigational medicine product (IMP) 2. Neuromuscular disorders 3. History of dysphagia 4. History of aspiration tendency or aspiration pneumonia 5. Known lung disease under continuous treatment 6. Congenital or acquired heart disease 7. Previous experience of side effects to Botulinum toxin type A 8. Present gastric diseases or dysfunction 9. Previous bariatric surgery 10. History of cancer 11. Serious binge eating disorder 12. Untreated hypothyroidism 13. 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) 14. Medication known to affect appetite 15. Syndromic obesity 16. Mentally immature to a degree that there is doubt about the subject's ability to assent 17. Issues relating to language or culture that may complicate trial participation 18. Pregnancy or breastfeeding

Locations (1)

St Olavs Hospital Trondheim University Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

BMI

Proportion of participants reaching a reduction in BMI z-score equal to or more than 1

Time frame: 12 months

Secondary Outcomes

Injection interval

Patient reports will indicate the appropriate re-injection interval

Time frame: 12 months

Patient adherence to treatment

Qualitative data based on interviews with patients and next of kin.

Time frame: 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

Time frame: 2 years

Data from ClinicalTrials.gov

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