Feasibility Pilot for the ReBOO-trial

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Olavs Hospital
• Collaborator: Norwegian University of Science and Technology
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

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