ObesityPhase 4TOBESNCT02040311
Topiramate: Long-Term Maintenance of Weight Loss Induced by Low-Calorie Diet in Obese Subjects
A Phase 4 study testing Topiramate 96 mg daily and Topiramate 192 mg daily in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the efficacy and safety of topiramate (96 mg or 192 mg daily) as compared to placebo in maintaining weight loss in obese subjects who participated in an eight week intensive non-pharmacologic weight loss program. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Topiramate 96 mg daily and Topiramate 192 mg daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 701 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2000to Jun 2002
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Read and signed the informed consent form after the nature of the study has been fully explained
- 18 to 75 years og age at enrollment
- subjects must have either:
- A body mass index BMI ≥ 33 kg/m*m and < 50 kg/m*m, or
- A BMI ≥ 30 kg/m*m < 50 kg/m*m if any of the following established co-morbidities are present:
- Controlled hypertension or dyslipidemia. Anti-hypertensive and hypo-lipidemic medication should have been at a stable dose for at least two months prior to enrollment. If subjects are clinically diagnosed with any of these conditions as a result of enrollment assessments, they can only continue in the enrollment phase if in the clinical judgment of the investigator initiation of anti-hypertensive or hypo-lipidemic therapy is not required.
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- Subjects diagnosed with type 2 diabetes by means of OGTT at enrollment visit and not requiring anti diabetic therapy according to the clinical judgement of the investigator.
- Stable weight (varying to more than 3 kg) for at least 3 months prior to enrollment.
- Female subjects must be post menopausal for at least a year or surgically incapable of childbearing, practicing abstinence an acceptable method of birth control. If a female subject of child bearing potential is practicing an acceptable method of birth control, she must have had a negative urine pregnancy test at enrollment, as well as at baseline, prior to receiving study drug.
- Randomization criteria
- Weight reduction of≥ 8% of enrollment body weight at the randomization visit;
- Subjects must have either:
- 2a) A BMI ≥ 30 kg/mm and < 50 kg/mm, or 2b) A BMI ≥ 27 kg/mm and < 50 kg/mm if any of the following established co-morbidities are present: controlled hypertension or dyslipidemia.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participating in the study.
- Prior exposure or known contraindication or hypersensitivity to topiramate;
- Exposure to any other experimental drug or device within 30 days prior to enrollment;
- Pregnancy or nursing or subjects who plan to become pregnant during the study;
- An established diagnosis of diabetes prior to study enrollment;
- History or evidence of clinically significant hepatic disease;
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- Evidence of renal impairment;
- Significant cardiovascular disease;
- Uncontrolled hypertension 180 / 100 mmHg
- Hypertensive subjects on medications must have been on the same dose of the same hypertensive medication for at least 2 months;
- Uncontrolled thyroid disease including hyper- or hypothyroidism or an abnormal TSH-level;
- A history of obesity with a known cause e.g. Cushings disease;
- A history or family history (first degree relatives) of kidney stones;
- Previous gastric restrictive surgery or other surgical procedures to cause weight loss, including liposuction;
- History of gluten or non-gluten induced enteropathy;
- Clinically significant lactose intolerance, in the opinion of the investigator;
- Malignancy or with a history of malignancy within 5 years prior to enrollment, other than basal cell carcinomas of the skin;
- History og seizures or significant CNS disorders;
- History of significant psychiatric disorders including schizophrenia, psychosis and major affective disorders;
- History of anorexia nervosa, bulimia og binge eating disorder;
- A significant change in smoking habit within 2 months of the enrollment visit, in the opinion of the investigator;
- History of drug or alcohol abuse within the previous 2 years;
- Positive results on any urine drug screen at enrollment;
- Use of any weight loss preparations within 30 days prior to enrollment;
- Use of any systemic corticosteroids within 30 days prior to enrollment;
- Clinically significant hematological or immunological disorder;
- Currently receiving psychotropic medications, except episodic use of certain medications;
- Receiving any excluded medication, depending on episodic or chronic use;
- Any significant condition that, in the opinion of the investigator, could interfere with the subjects participation or compliance in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Topiramate in Weight Loss Maintenance in Obese Subjects Following Participation in an Intensive, Non-pharmacologic Weight Loss Program
The purpose of this study is to determine the efficacy and safety of topiramate (96 mg or 192 mg daily) as compared to placebo in maintaining weight loss in obese subjects who participated in an eight week intensive non-pharmacologic weight loss program.
The primary efficacy endpoint will be the percent change in body weight from enrollment visit to week 60.
Read the detailed description
The study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. It was originally designed to last a total of 74 weeks: an 8 week non.pharmacologic low-calorie (800 to 1000 kcl/d) weight loss run-in phase, an 8 week titration phase, 52 week maintenance phase, and 6 week drug taper and follow up phase.
- Conditions
- Obesity
- Being tested
- Topiramate 96 mg daily, Topiramate 192 mg daily, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate 96 mg dailyDrug
Topiramate 192 mg dailyDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Topiramate 96 mg daily | Experimental | Not described Receives: Drug: Topiramate 96 mg daily |
| Topiramate 192 mg daily | Experimental | Not described Receives: Drug: Topiramate 192 mg daily |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 60 weeks
Secondary outcomes (1)
blood lipids
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startAug 2000
- Primary completionJun 2002
- Study completionJun 2002
Why it stopped: Study was terminated early as sponsor wanted to develop an improved formulation.
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.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- R W Johnson Pharmaceutical Research Institute
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne V Astrup, phD.MD, Principal investigator, Department of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040311
- Sponsor's protocol ID
- PRI/TOP-INT-35
- Acronym
- TOBES
- Status last verified
- Jan 2014
- First submitted
- 7 Jan 2014
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Topiramate in Weight Loss Maintenance in Obese Subjects Following Participation in an Intensive, Non-pharmacologic Weight Loss Program
- ClinicalTrials.gov ID
- NCT02040311
- Acronym / sponsor ID
- TOBES / PRI/TOP-INT-35
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early as sponsor wanted to develop an improved formulation.
- Enrolment
- 701 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- R W Johnson Pharmaceutical Research Institute
- Study start
- Aug 2000
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 20 Jan 2014 (estimated)
- 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.
The purpose of this study is to determine the efficacy and safety of topiramate (96 mg or 192 mg daily) as compared to placebo in maintaining weight loss in obese subjects who participated in an eight week intensive non-pharmacologic weight loss program.
The primary efficacy endpoint will be the percent change in body weight from enrollment visit to week 60.
Detailed description
The study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. It was originally designed to last a total of 74 weeks: an 8 week non.pharmacologic low-calorie (800 to 1000 kcl/d) weight loss run-in phase, an 8 week titration phase, 52 week maintenance phase, and 6 week drug taper and follow up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topiramate 96 mg daily | Experimental | Drug: Topiramate 96 mg daily |
| Topiramate 192 mg daily | Experimental | Drug: Topiramate 192 mg daily |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Read and signed the informed consent form after the nature of the study has been fully explained
- 18 to 75 years og age at enrollment
- subjects must have either:
- Controlled hypertension or dyslipidemia. Anti-hypertensive and hypo-lipidemic medication should have been at a stable dose for at least two months prior to enrollment. If subjects are clinically diagnosed with any of these conditions as a result of enrollment assessments, they can only continue in the enrollment phase if in the clinical judgment of the investigator initiation of anti-hypertensive or hypo-lipidemic therapy is not required.
- Subjects diagnosed with type 2 diabetes by means of OGTT at enrollment visit and not requiring anti diabetic therapy according to the clinical judgement of the investigator.
Key exclusion criteria (29 listed)
- Subjects who meet any of the following criteria will be excluded from participating in the study.
- Prior exposure or known contraindication or hypersensitivity to topiramate;
- Exposure to any other experimental drug or device within 30 days prior to enrollment;
- Pregnancy or nursing or subjects who plan to become pregnant during the study;
- An established diagnosis of diabetes prior to study enrollment;
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 |
|---|---|---|
| Topiramate 96 mg daily | Drug | Topiramate 96 mg daily |
| Topiramate 192 mg daily | Drug | Topiramate 192 mg daily |
| Placebo | Drug | placebo |
Primary outcome
weight loss
Time frame: 60 weeks
1 secondary outcome
blood lipids
Time frame: 60 weeks
Results and safety
The study was stopped early (reason given: Study was terminated early as sponsor wanted to develop an improved formulation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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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.
Arne V Astrup, phD.MD principal investigator
Department of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate 96 mg daily and Topiramate 192 mg daily in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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 13 inclusion and 29 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: stopped early, as of the sponsor's last update on 20 Jan 2014. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 stopped early (reason given: Study was terminated early as sponsor wanted to develop an improved formulation.). Results are not available in the source record.
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?
weight loss (time frame: 60 weeks). 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 20 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.