Feasibility Pilot for the ReBOO-trial

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: Intragastric botulinum toxin type A

• Registration Number: NCT03079557
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-26
• Study First Submitted QC: 2017-03-08
• Study Start: 2017-03-14
• Study First Posted: 2017-03-14
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intragastric botulinum toxin type A	Intragastric botulinum toxin type A	Botulinum toxin A (Allergan) injected intragastrically in the antrum

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St Olavs Hospital Trondheim University Hospital; 🇳🇴 Trondheim, Norway