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Pediatric ObesityPhase 2MAABS ProtocolNCT04572217

Medications After Adolescent Bariatric Surgery

A Phase 2 study testing Topiramate and Phentermine in people with Pediatric Obesity, run by Janey Pratt at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will assess the feasibility to assess practicality of early weight loss medication usage in adolescent patients post-VSG with inadequate weight loss. Participants who enroll in the study will be prescribed off-label use of weight loss medications for a period of up to 1 year. Read more about this study

Who is it for?
Ages 12 to 25 years
Conditions the study is for
Pediatric Obesity
What is being tested?
Topiramate and Phentermine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 1 Jun 2022
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 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Surgical patients in the LPCH/Stanford bariatric and weight management clinics
  • Inadequate weight loss after vertical sleeve gastrectomy

Who cannot join

  • Adequate weight loss after surgery;
  • Unwilling to consent or adhere to safety monitoring plan;
  • Any life-threatening or terminal diseases
  • Currently pregnant, breastfeeding, or thinking of becoming pregnant
  • Allergy or medical contraindication to phentermine or topiramate;
  • History of drug or alcohol abuse;
Show all 9Show fewer
  • No known medication interactions;
  • Significant renal or hepatic impairment;
  • Participation in a study of an investigational medication 30 days prior to screening, while the patient is on study, and for 30 days after their last dose of study treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study

This study will assess the feasibility to assess practicality of early weight loss medication usage in adolescent patients post-VSG with inadequate weight loss. Participants who enroll in the study will be prescribed off-label use of weight loss medications for a period of up to 1 year.

Being tested
Topiramate, Phentermine
Keywords
Adolescent, Bariatric Surgery, Medications, Weight loss
Medical subject headings
Pediatric Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TopiramateDrug

    Topiramate (starting dose 25 mg daily, max dose 100 mg daily)

  • PhentermineDrug

    Phentermine (starting dose 8 mg, max dose 16 mg)

Study groups in NCT04572217
Study groupRoleWhat they receive
Medication GroupExperimentalAdolescent patients post vertical sleeve gastrectomy who have had inadequate weight loss, who consented for use of off-label medications prescribed at the discretion (one or both) of physician. Patients will be followed every 2-12 weeks over one year. All patients in this group will continue to follow the standard of care procedures of our multidisciplinary bariatric clinic, including frequent follow-up appointments, nutrition guidance, vitamin supplementation, exercise instruction, and healthy lifestyle education.
Receives: Drug: Topiramate; Drug: Phentermine
Non-Medication GroupNo interventionAdolescent patients post vertical sleeve gastrectomy who had inadequate weight loss and did not consent for use of off-label medications. All patients in this group will continue to follow the standard of care procedures of our multidisciplinary bariatric clinic, including frequent follow-up appointments, nutrition guidance, vitamin supplementation, exercise instruction, and healthy lifestyle education.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who are able to consent for off-label medication use as a measure of feasibility

    Measured: Up to 1 year

Secondary outcomes (5)

  1. Average daily rate of compliance with medication administration

    Measured: Up to 1 year

  2. Percent change from baseline in % BMI

    Measured: Baseline (initiation of medication), 1 year

  3. Type of weight loss medication prescribed

    Type of weight loss medication prescribed, according to type and dose

    Measured: Up to 1 year

  4. Number of participants experiencing side effects

    Measured: Up to 1 year

  5. Timing of the implementation of off-label medications after vertical sleeve gastrectomy

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2020
  2. Study start1 Jun 2022
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Why it stopped: No available funding

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Pilot feasibility study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04572217
Sponsor's protocol ID
54967
Other IDs
1092951-100- KHAAX
Acronym
MAABS Protocol
Status last verified
May 2025
First submitted
25 Sep 2020
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aldenkamp AP, Baker G, Mulder OG, Chadwick D, Cooper P, Doelman J, Duncan R, Gassmann-Mayer C, de Haan GJ, Hughson C, Hulsman J, Overweg J, Pledger G, Rentmeester TW, Riaz H, Wroe S. A multicenter, randomized clinical study to evaluate the effect on cognitive function of topiramate compared with valproate as add-on therapy to carbamazepine in patients with partial-onset seizures. Epilepsia. 2000 Sep;41(9):1167-78. doi: 10.1111/j.1528-1157.2000.tb00322.x.

    PubMed 10999556

  • Boyer EW, Shannon M. The serotonin syndrome. N Engl J Med. 2005 Mar 17;352(11):1112-20. doi: 10.1056/NEJMra041867. No abstract available.

    PubMed 15784664

  • Chanoine JP, Richard M. Early weight loss and outcome at one year in obese adolescents treated with orlistat or placebo. Int J Pediatr Obes. 2011 Apr;6(2):95-101. doi: 10.3109/17477166.2010.519387. Epub 2010 Sep 22.

    PubMed 20858149

  • Czepiel KS, Perez NP, Campoverde Reyes KJ, Sabharwal S, Stanford FC. Pharmacotherapy for the Treatment of Overweight and Obesity in Children, Adolescents, and Young Adults in a Large Health System in the US. Front Endocrinol (Lausanne). 2020 May 13;11:290. doi: 10.3389/fendo.2020.00290. eCollection 2020.

    PubMed 32477270

  • Doose DR, Wang SS, Padmanabhan M, Schwabe S, Jacobs D, Bialer M. Effect of topiramate or carbamazepine on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in healthy obese and nonobese female subjects. Epilepsia. 2003 Apr;44(4):540-9. doi: 10.1046/j.1528-1157.2003.55602.x.

    PubMed 12681003

  • Hendricks EJ, Srisurapanont M, Schmidt SL, Haggard M, Souter S, Mitchell CL, De Marco DG, Hendricks MJ, Istratiy Y, Greenway FL. Addiction potential of phentermine prescribed during long-term treatment of obesity. Int J Obes (Lond). 2014 Feb;38(2):292-8. doi: 10.1038/ijo.2013.74. Epub 2013 May 17.

    PubMed 23736363

  • Kramer CK, Leitao CB, Pinto LC, Canani LH, Azevedo MJ, Gross JL. Efficacy and safety of topiramate on weight loss: a meta-analysis of randomized controlled trials. Obes Rev. 2011 May;12(5):e338-47. doi: 10.1111/j.1467-789X.2010.00846.x. Epub 2011 Mar 28.

    PubMed 21438989

  • Lewis KH, Fischer H, Ard J, Barton L, Bessesen DH, Daley MF, Desai J, Fitzpatrick SL, Horberg M, Koebnick C, Oshiro C, Yamamoto A, Young DR, Arterburn DE. Safety and Effectiveness of Longer-Term Phentermine Use: Clinical Outcomes from an Electronic Health Record Cohort. Obesity (Silver Spring). 2019 Apr;27(4):591-602. doi: 10.1002/oby.22430.

    PubMed 30900410

  • Ahamada Safna Mariyam M, Sen S, Vijayan K. Topiramate: Safety in migraine patients. J Young Pharm. 2013 Mar;5(1):30-1. doi: 10.1016/j.jyp.2012.12.001. Epub 2013 Mar 6. No abstract available.

    PubMed 24023450

  • Martin R, Kuzniecky R, Ho S, Hetherington H, Pan J, Sinclair K, Gilliam F, Faught E. Cognitive effects of topiramate, gabapentin, and lamotrigine in healthy young adults. Neurology. 1999 Jan 15;52(2):321-7. doi: 10.1212/wnl.52.2.321.

    PubMed 9932951

  • Rich S, Rubin L, Walker AM, Schneeweiss S, Abenhaim L. Anorexigens and pulmonary hypertension in the United States: results from the surveillance of North American pulmonary hypertension. Chest. 2000 Mar;117(3):870-4. doi: 10.1378/chest.117.3.870.

    PubMed 10713017

  • Rissanen A, Lean M, Rossner S, Segal KR, Sjostrom L. Predictive value of early weight loss in obesity management with orlistat: an evidence-based assessment of prescribing guidelines. Int J Obes Relat Metab Disord. 2003 Jan;27(1):103-9. doi: 10.1038/sj.ijo.0802165.

    PubMed 12532161

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topiramate and Phentermine in people with Pediatric Obesity, run by Janey Pratt at 1 site in United States.

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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 31 May 2025. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.

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?

Number of participants who are able to consent for off-label medication use as a measure of feasibility (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04572217, which also lists 12 linked publications.

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 31 May 2025.

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