Feasibility Pilot for the ReBOO-trial

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03079557

Acronym

ReBOO

Enrollment

Registered

2017-03-14

Start date

2017-03-14

Completion date

2019-04-30

Last updated

2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Adolescent, Injections, intraperitoneal, Endoscopy, Botulinum Toxins, Type A, OnabotulinumtoxinA

Brief summary

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.

Interventions

DRUGIntragastric botulinum toxin type A

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026