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Effects of rimonabant (Acomplia) on obesity in adults with Prader-Willi Syndrome

Effects of rimonabant (Acomplia) on obesity in adults with Prader-Willi Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006305-25-SE
Enrollment
Unknown
Registered
2008-01-03
Start date
2008-02-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese adults with Prader Willi Syndrome MedDRA version: 9.1 Level: LLT Classification code 10036476 Term: Prader-Willi syndrome MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity

Interventions

Trade Name: ACOMPLIA 20 mg film-coated tablets Pharmaceutical Form: Film-coated tablet

Sponsors

Karolinska University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Genetically verified Prader-Willi syndrome diagnosis Age between 18 and 50 years BMI>28 Patients that have signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Serious depression Malignancy Increased liver enzymes (ASAT or ALAT >2.5 normal range) Pregnant or lactating women Medication with antidepressants Medication inhibiting CYP3A Significant reduction in kidney function Patients with epilepsia

Design outcomes

Primary

MeasureTime frame
Main Objective: To explore the effects of rimonabant in adults with prader willi syndrome by measuring weight reduction and body composition.;Primary end point(s): Body weight BMI Waist/hip ratio Body composition (measured by Bio-impedance) 3-days food recall, including VAS rating of hunger Blood lipids (total, HDL, LDL, cholesterol, Lp(a), triglycerides) P-glucose, insulin, HOMA-index ;Secondary Objective: The secondary objectives will be to evaluate the effect of rimonabant on metabolic parameters (blood glucose, insulin, blood lipids, adipoectin, leptin and grehlin) and insulin resistance (HOMA-index). In addition a decrease in appetite and food intake will be recorded. Safety will be measured by analyse of liver enzymes (ASAT, ALAT) repeated measurements of blood pressure and pulse, and by responses to questionnaires concerning wellbeing, and by evaluating adverse events.—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026