A Phase 4 interventional study of Topiramate and Placebo in Obesity, Polycystic Ovary Syndrome and Hyperandrogenism, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-07-01.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 4, Interventional, and Treatment
Among 33 studies testing topiramate in Obesity — 3 open to participants now, 4 under way, none of them phase 3. Topiramate · Obesity.
Among the 33 studies testing topiramate in Obesity, this one is the 20th largest by planned enrollment, is one of 2 that started in 2014, is one of 7 in phase 4, and was the 26th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 80 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →3 of the 33 studies testing topiramate in Obesity are open now, in 1 country. Each count lists the studies.
Topiramate: first FDA approval 1996 (TOPAMAX). What it is approved for, and how studies give it, is on its page →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 40 Years · female · no healthy volunteers.
The full table on the hub →33 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 2 started in 2014.
Median enrollment 120 across the 33 interventional studies. Of the 28 that completed or were terminated, 12 (43%) have results posted.
19 of 33 have an industry lead sponsor. The 10 most frequent:
Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
14 studies in Obesity by Hospital de Clinicas de Porto Alegre: 1 open now, 2 under way, none of them phase 3. Of 5 finished, 0 (0%) have results posted.
Among the 14 studies in Obesity by Hospital de Clinicas de Porto Alegre, this one is the 7th largest by planned enrollment, is one of 2 that started in 2014, is the only one in phase 4, and was the 10th registered.
Hospital de Clinicas de Porto Alegre’s Obesity studies by the year they started, since 2007.
2 of the studies testing topiramate in Obesity that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06854614The Cleveland ClinicSequential Therapy Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial) | 2027-04-28 |
| NCT05975580University of California, IrvinePharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery | 2027-07-31 |
Among the 33 studies testing topiramate in Obesity, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Hospital de Clinicas de Porto Alegre’s 14 in Obesity:
Nothing recorded among them since 2026-09-25.
Treatment of obesity related to Polycystic Ovary Syndrome with topiramate or placebo to assess improvement of clinical and laboratory parameters after 6 months of follow-up
Randomized double blind placebo-controlled clinical trial. Polycystic ovary syndrome (PCOS) is a frequent endocrinopathy, affecting more than 10% of women of reproductive age. It is associated with a higher prevalence of obesity and insulin resistance, with a higher risk for diabetes, dyslipidemia and hypertension. Topiramate is a drug used in the treatment of epilepsy and migraine prophylaxis since the 1990s and several studies show an association with weight loss. This medicine is administered in combination with phentermine in other countries, with variable weight loss. Despite evidence of the benefit of topiramate for weight loss, there is still no record of studies evaluating this drug in patients with PCOS for the treatment of obesity. The objective of this project is to evaluate the results of treatment with topiramate in terms of weight reduction, reduction of serum androgens and changes in body composition, in patients with PCOS and obese, associated with a low-calorie diet, over a period of six months. Eighty patients with PCOS (18 to 40 years old) seen at the HCPA Endocrinology Service outpatient clinic who are overweight with a BMI> or = 27 kg / m2 associated with at least one comorbidity or obesity (BMI 30-40) will be included. Patients will be randomized to 2 groups: Topiramate and Placebo and the 2 groups will receive a low-calorie diet.
Anthropometric, clinical, hormonal, nutritional and body composition assessment will be performed before, during and after treatments. It is expected to determine whether the addition of topiramate to dietary treatment can improve metabolic, hormonal and weight loss outcomes in women with PCOS.
Research Objective: General objective: To evaluate the results of treatment with topiramate in patients with PCOS and obese, associated with a low-calorie diet, in six months of treatment.
Specific objectives: To evaluate the response to the proposed treatment in terms of weight reduction and body mass index (BMI), reduction of serum androgens, changes in body composition, in addition to assessing minor psychiatric disorders possibly associated through the Self-Reporting screening questionnaire. Questionnaire (SRQ-20).
Assessment of Risks and Benefits: The risks of the project are mainly related to the use of the drug topiramate. This drug has an extensive list of adverse effects, in addition to the side effect on appetite and weight, the most common are paresthesias, drowsiness, lethargy, attention disorder, mood disorders, depression, taste changes and psychomotor disorders. However, studies show that the majority of adverse reactions were mild to moderate in severity. Other risks inherent to the study are the absence of previous studies in the target population and discomfort in relation to the number of visits, additional tests and blood samples for an extended period of 6 months. The benefits of the study are related to the acquisition of knowledge and the likely positive results may benefit future patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with the same characteristics as the intervention group. Bottles containing 30 white and green tablets are provided to the participants. The number of bottles is anticipated according to the day of the next appointment. Patients should take 2 tablets bedtime with a full glass of water. Bottles are labeled as TPMT100 or TPMT200. The dosage of each tablet is 25 mg, totaling 50 mg / day. The dosage is doubled at 3 months if the patient does not lose at least 3% of the initial weight.
Drug: Placebo
Patients with the same characteristics as the placebo group. Bottles containing 30 white and green tablets are provided to the participants. The number of bottles is anticipated according to the day of the next appointment. Patients should take 2 tablets bedtime with a full glass of water. Bottles are labeled as TPMT100 or TPMT200. The dosage of each tablet is 25 mg, totaling 50 mg / day. The dosage is doubled at 3 months if the patient does not lose at least 3% of the initial weight.
Drug: Topiramate
topiramate 25mg is coated in tablets in an independent laboratory
innocuous substance is coated in tablets in an independent laboratory
Change of Body Mass index (BMi) at 6 months
change of Body Mass index (BMi) in kg/m² from the baseline; weight and height will be combined to report BMI
Time frame: 6 months
change in the modified Ferriman-Gallwey Hirsutism Score (mFG) at 6 months
In the modified method, hair growth is rated from 0 (no growth of terminal hair) to 4 (extensive hair growth) in each of the nine locations (Upper lip, Chin, Chest, Upper back, Lower back, Upper abdomen, Lower abdomen, Upper arms, Thighs). A patient's score may therefore range from a minimum score of 0 to a maximum score of 36. A score of 6 or higher will be adopted as indicative of androgen excess.
Time frame: 6 months
Change of testosterone at 6 months
Change of testosterone (ng/mL) at 6 months from the baseline
Time frame: 6 months
Change of glucose at 6 months
Change of glucose(mg/dL) at 6 months from the baseline
Time frame: 6 months
Change of triglyceride at 6 months
Change of triglyceride (mg/dL) at 6 months from the baseline
Time frame: 6 months
Change of High-density lipoprotein (HDL) at 6 months
Change of HDL cholesterol (mg/dL) at 6 months from the baseline
Time frame: 6 months
Change of total cholesterol at 6 months
Change of total cholesterol (mg/dL) at 6 months from the baseline
Time frame: 6 months
Change of Low-density lipoprotein (LDL) at 6 months
Change of LDL cholesterol (mg/dL) at 6 months from the baseline. LDL cholesterol will be calculated with the Friedewald formula, an estimation of LDL-c level that uses the following levels of total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-c): LDL-c (mg/dL) = TC (mg/dL) - HDL-c (mg/dL) - TG (mg/dL)/5
Time frame: 6 months
Change of homeostatic model assessment (HOMA-IR) at 6 months
Change of HOMA-IR at 6 months from the baseline. HOMA-IR will be calculated according to the formula: fasting insulin (µU/L) x fasting glucose (nmol/L)/22.5.
Time frame: 6 months
change in systolic blood pressure at 6 months
change in systolic blood pressure (mmHg) at 6 months from baseline.
Time frame: 6 months
change in diastolic blood pressure at 6 months
change in diastolic blood pressure (mmHg) at 6 months from baseline.
Time frame: 6 months
change of body composition at 6 months
Change in body composition evaluated through Dual-energy X-ray absorptiometry (DXA) from the baseline
Time frame: 6 months
Change in anxiety score at 6 months
Change in anxiety score, assessed through the self-report questionnaire-20 (SRQ 20), consisting of 20 questions with a yes / no answer, assigning 1 point to the "yes" answer. A cut-off point of 8 or more indicates an anxiety disorder, with a minimum of zero and a maximum of 20 points.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2014 (actual). Primary completion is estimated for Dec 2021, 91 months after the start.
Of 190 non-industry phase 4 interventional studies under Obesity, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 91 months is above that.
Counting every sponsor, half of 210 studies reached it within 31 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Topiramate
Hospital de Clinicas de Porto Alegre →