Topiramate: Long-Term Maintenance of Weight Loss Induced by Low-Calorie Diet in Obese Subjects

NCT02040311 | Terminated Phase 4

• 1 other identifier: PRI/TOP-INT-35
• Study Type: interventional
• Target: 701
• Locations: 1 country
• Sites: 1

Brief 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. The primary efficacy endpoint will be the percent change in body weight from enrollment visit to week 60.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• weight loss

  60 weeks

Secondary Outcomes (1)

• blood lipids

  60 weeks

Study Arms (3)

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

Interventions

Topiramate 96 mg daily DRUG

Topiramate 96 mg daily

Topiramate 192 mg daily DRUG

Topiramate 192 mg daily

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Read and signed the informed consent form after the nature of the study has been fully explained
• 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.
• 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:
• a) A BMI ≥ 30 kg/m\*m and \< 50 kg/m\*m, or 2b) A BMI ≥ 27 kg/m\*m and \< 50 kg/m\*m if any of the following established co-morbidities are present: controlled hypertension or dyslipidemia.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• University of Copenhagen: lead
• R W Johnson Pharmaceutical Research Institute: collaborator

Study Sites (1)

Department of Human Nutrition

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Arne V Astrup, phD.MD

  Department of Human Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ph.D, M.D.

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 20, 2014
• Study Start: August 1, 2000
• Primary Completion: June 1, 2002
• Study Completion: June 1, 2002
• Last Updated: January 20, 2014

Record last verified: 2014-01

Locations

DK (1)