Randomized Study of Pergolide in Children With Tourette Syndrome
pergolide
Maladies des ganglions de la base+16
+ Maladies du cerveau
+ Maladies du système nerveux central
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1994
Date à laquelle le premier participant a commencé l'étude.PROTOCOL OUTLINE: This is a three part study: part I is a randomized, double blind, fixed single dose study; part II is a randomized, open label, stratified study; and part III is a randomized, double blind, placebo controlled study. Part I patients are randomized to receive oral pergolide at one of three dose levels or placebo for 10 weeks. Part II patients are randomized to receive either low or high dose pergolide for 4 weeks. Part III patients are randomized to first receive either pergolide or placebo by oral fixed doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after a 2-week placebo run-in. Patients then cross over to receive the other treatment after another 2 weeks of placebo run-in. Total treatment duration is 16 weeks. Patients are followed at 6 months. Completion date provided represents the completion date of the grant per OOPD records
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.74 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 7 à 17 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- DSM IV primary diagnosis of Tourette syndrome (GTS) Multiple Axis I and Axis II diagnoses allowed Tourette symptom severity great enough to warrant medication (CGI severity index at least 4) No chronic motor tic disorder or transient tic disorder, anorexia nervosa, pervasive developmental disorders, substance/alcohol abuse or dependence within the past year, schizophrenia or any psychotic disorder --Prior/Concurrent Therapy-- At least 4 weeks since prior neuroleptic therapy At least 2 weeks since all other prior medications No concurrent neuroleptic therapy or psychotropic therapy (i.e., antidepressant or anticholinergic) No concurrent medication that may alter or interact with pergolide --Patient Characteristics-- Performance status: Outpatient status Hematopoietic: Normal or clinically insignificant values Hepatic: Normal or clinically insignificant values Renal: Normal or clinically insignificant values Cardiovascular: Normal electrocardiogram Other: No serious or unstable medical illness (i.e., diabetes, seizure disorder); Must be able to perform required measurements (i.e., no low I.Q.); Effective contraception required by all fertile patients