ObesityPhase 2ReBOONCT03079557
Feasibility Pilot for the ReBOO-trial
A Phase 2 study testing Intragastric botulinum toxin type A in people with Obesity, run by St. Olavs Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- Intragastric botulinum toxin type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 14 Mar 2017to 30 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Intragastric botulinum toxin type A
- Keywords
- Adolescent, Injections, intraperitoneal, Endoscopy, Botulinum Toxins, Type A, OnabotulinumtoxinA
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intragastric botulinum toxin type ADrug
Also called Allergan
200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months
| Study group | Role | What they receive |
|---|---|---|
| Intragastric botulinum toxin type A | Experimental | Botulinum toxin A (Allergan) injected intragastrically in the antrum Receives: Drug: Intragastric botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Proportion of participants reaching a reduction in BMI z-score equal to or more than 1
Measured: 12 months
Secondary outcomes (3)
Injection interval
Patient reports will indicate the appropriate re-injection interval
Measured: 12 months
Patient adherence to treatment
Qualitative data based on interviews with patients and next of kin.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start14 Mar 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Bård Eirik Kulseng, prof, Study director, Norwegian University of Science and Technology, Fac MH, IKOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079557
- Sponsor's protocol ID
- ESA 17/1878
- Other IDs
- 2016-000326-19, 2016
- Acronym
- ReBOO
- Status last verified
- Sep 2020
- First submitted
- 26 Feb 2017
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomised, Open Feasibility Pilot for the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' (ReBOO) Trial
- ClinicalTrials.gov ID
- NCT03079557
- Acronym / sponsor ID
- ReBOO / ESA 17/1878
- Conditions
- Obesity
- Keywords
- Adolescent, Injections, intraperitoneal, Endoscopy, Botulinum Toxins, Type A, OnabotulinumtoxinA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intragastric botulinum toxin type A | Experimental | Drug: Intragastric botulinum toxin type ABotulinum toxin A (Allergan) injected intragastrically in the antrum |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intragastric botulinum toxin type AAlso: Allergan200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months | Drug | Intragastric botulinum toxin type A |
Primary outcome
BMI
Time frame: 12 months
Proportion of participants reaching a reduction in BMI z-score equal to or more than 1
3 secondary outcomes
Injection interval
Time frame: 12 months
Patient adherence to treatment
Time frame: 12 months
Incidence of treatment-emergent adverse events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bård Eirik Kulseng, prof study director
Norwegian University of Science and Technology, Fac MH, IKOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intragastric botulinum toxin type A in people with Obesity, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.