Feasibility Pilot for the ReBOO-trial

NCT ID: NCT03079557

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-14
• Study Completion Date: 2019-04-30

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intragastric botulinum toxin type A

Botulinum toxin A (Allergan) injected intragastrically in the antrum

Group Type: EXPERIMENTAL

Intragastric botulinum toxin type A

Intervention Type: DRUG

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

Interventions

Intragastric botulinum toxin type A

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

Intervention Type: DRUG

Other Intervention Names

Allergan

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bård Eirik Kulseng, prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology, Fac MH, IKOM

Locations

St Olavs Hospital Trondheim University Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

2016-000326-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ESA 17/1878

Identifier Type: -

Identifier Source: org_study_id