NCT03079557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Mar 2017

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

February 26, 2017

Last Update Submit

September 21, 2020

Conditions

Obesity

Keywords

AdolescentInjections, intraperitonealEndoscopyBotulinum Toxins, Type AOnabotulinumtoxinA

Outcome Measures

Primary Outcomes (1)

  • BMI

    Proportion of participants reaching a reduction in BMI z-score equal to or more than 1

    12 months

Secondary Outcomes (3)

  • Injection interval

    12 months

  • Patient adherence to treatment

    12 months

  • Incidence of treatment-emergent adverse events

    2 years

Study Arms (1)

Intragastric botulinum toxin type A

EXPERIMENTAL

Botulinum toxin A (Allergan) injected intragastrically in the antrum

Drug: Intragastric botulinum toxin type A

Interventions

Intragastric botulinum toxin type ADRUG

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

Also known as: Allergan
Intragastric botulinum toxin type A

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Written (signed) informed consent
  • 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
  • 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)

You may not qualify if:

  • Known hypersensitivity to excipients in the investigational medicine product (IMP)
  • Neuromuscular disorders
  • History of dysphagia
  • History of aspiration tendency or aspiration pneumonia
  • Known lung disease under continuous treatment
  • Congenital or acquired heart disease
  • Previous experience of side effects to Botulinum toxin type A
  • Present gastric diseases or dysfunction
  • Previous bariatric surgery
  • History of cancer
  • Serious binge eating disorder
  • Untreated hypothyroidism
  • 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)
  • Medication known to affect appetite
  • Syndromic obesity
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital Trondheim University Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Obesity

Interventions

Idoxuridine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Bård Eirik Kulseng, prof

    Norwegian University of Science and Technology, Fac MH, IKOM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 14, 2017

Study Start

March 14, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)