Feasibility Pilot for the ReBOO-trial (ReBOO)

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

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Intragastric botulinum toxin type A

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs Hospital Trondheim University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intragastric botulinum toxin type A; Botulinum toxin A (Allergan) injected intragastrically in the antrum	Drug: Intragastric botulinum toxin type A; 200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months; Other Names: Allergan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Study Director: Bård Eirik Kulseng, prof, Norwegian University of Science and Technology, Fac MH, IKOM

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2017
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: February 26, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (ACTUAL): March 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Adolescent; Endoscopy; OnabotulinumtoxinA; Botulinum Toxins, Type A; Injections, intraperitoneal
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: ESA 17/1878; 2016-000326-19 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No