View clinical trials related to Hyperphagia.
Filter by:This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).
There is no specific treatment for core symptoms of PWS. Regarding behavioral and psychiatric symptoms (hyperphagia, imulsivity and self-mutilations), one of the only drug options consists in antipsychotics, that are not efficient and might be responsible for a worsening of the weight gain (major issue in PWS). An alternative therapeutic approach for behavioral disturbances has been suggested by some authors with topiramate (Epitomax®), an antiepileptic drug that can be used as a mood stabilizer and anti-impulsive. In addition, topiramate is used as a treatment for eating disorders because it induces loss of weight and appetite. This last effect might be useful in the case of SPW. Except for some clinical case reports, the investigators only found one open study for topiramate in SPW 8 patientssuggesting promising effects. There si however no placebo controlled study.. Objective: To evaluate the efficacy of topiramate (200 mg / d) on Eating disorders (E), self Mutilations (M), irritability and Impulsivity (I), metabolic status, and tolerance among of PWS patients. Methodology: This is a multicenter (out-patients in Toulouse, Reims, Nantes and Paris and in-patients in Hendaye) 8 weeks double-blind placebo controlled study . Subjects (n = 125 for 112 analyzable) all having PWS, aged 12 years-old and more should have any of the following symptoms: E, M and U (see above). All subjects will be randomly allocated into two groups one taking a placebo, the other taking topiramate (50mg / day initially, increasing up to 50mg per week 200mg / day). The population of analyzable patients in and out patient will be of equal size (n = 56). The inclusion period is two years.. Are excluded subjects with antipsychotic or mood stabilizer medication or topiramate. The primary endpoint will be the rate of responders, with response defined by obtaining a score of 1 or 2 on the CGI improvement after 8 weeks of treatment Other assessments, secondary endpoints : - Clinic: Weight / Size / Self-injury behavior (french Echelle des Conduites Auto et Hétéro Aggressives, ECAHA)) - Psychometric: C-SHARP and A-SHARP / Conners (Impulsivity) / Dickens (Eating behavior for PWS) - Organic: NFS, serum electrolytes, creatinine, ammonia plasma, serum bicarbonate, AST / ALT / GGT, ghrelin, fasting glucose, lipid profile and insulin, leptin, TG and HbA1c. - Side effects of topiramate: SAPS / SANS and BPRS (hallucinations), anxiety scales and laboratory tests.
Obesity is worldwide a public health problem. According to World Health Organization (WHO), overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million adults die each year. Food addiction is one of the causes of obesity that may benefit from new therapeutic options.
Excessive weight gain is a cardinal feature of Prader-Willi syndrome (PWS) for which there is presently no effective treatment. It is caused by increased appetite, decreased perception of satiety and obsessive and compulsive behaviour towards food. Ghrelin is a powerful appetite-stimulating hormone. Patients with PWS have markedly elevated ghrelin levels, suggesting that it may be responsible for the increased food intake. The goal of the study is to determine whether treatment with somatostatin (Sandostatin), a hormone that inhibits ghrelin, is an effective treatment for the prevention and treatment of weight excess in patients with PWS.