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Completed

NCT Number: NCT03079557

Feasibility Pilot for the 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Olavs Hospital Trondheim University Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Mentally immature to a degree that there is doubt about the subject's ability to assent
  • Issues relating to language or culture that may complicate trial participation
  • Pregnancy or breastfeeding

Treatment and study plan

Intragastric botulinum toxin type A

Drug

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

Other names: Allergan

Primary outcomes

  1. BMI

    Time frame: 12 months

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

Secondary outcomes

  1. Injection interval

    Time frame: 12 months

    Patient reports will indicate the appropriate re-injection interval

  2. Patient adherence to treatment

    Time frame: 12 months

    Qualitative data based on interviews with patients and next of kin.

  3. Incidence of treatment-emergent adverse events

    Time frame: 2 years

    All adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) will be evaluated

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Acronym: ReBOO

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 14, 2017
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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