Feasibility Pilot for the ReBOO-trial

Obesity Clinical Trial

— ReBOO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079557
• Other study ID #: ESA 17/1878
• Secondary ID: 2016-000326-19
• Status: Completed
• Phase: Phase 2
• Start date: March 14, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2020
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Intragastric botulinum toxin type A
200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months

Locations

Country	Name	City	State
Norway	St Olavs Hospital Trondheim University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Proportion of participants reaching a reduction in BMI z-score equal to or more than 1	12 months
Secondary	Injection interval	Patient reports will indicate the appropriate re-injection interval	12 months
Secondary	Patient adherence to treatment	Qualitative data based on interviews with patients and next of kin.	12 months
Secondary	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