OBJECTIVE: To determine whether pergolide, a mixed D1/D2/D3 dopamine agonist, is efficacious and safe in the treatment of children with chronic tic disorders and Tourette syndrome. BACKGROUND: Neuroleptics, which block dopamine transmission, are currently used to treat children with severe tics, but major side effects and limited efficacy reduce clinical utility. Prior open-label and crossover studies of pergolide suggest potential benefit. METHODS: The authors enrolled 57 children and adolescents, ages 7 to 17 years, randomizing them in a 2:1 ratio to either pergolide (0.15 to 0.45 mg per day) orplacebo. Tic symptoms had to be >30 on the Yale Global Tic Severity Scale (YGTSS). The primary outcome measure was change in tic severity assessed by YGTSS. RESULTS: Compared to placebo treatment, pergolide treatment was associated with lower tic severity scores (treatment effect 8.8, pergolide vs placebo; 95% CI 0.1 to 17.6; p = 0.05) and attention-deficit hyperactivity disorder symptoms scores (treatment effect 3.8; 95% CI 0.7 to 6.8; p = 0.02). No patient had a serious adverse event and pergolide was well tolerated. CONCLUSIONS: In this randomized, placebo-controlled trial, pergolide appeared to be an efficacious and safe medication for tic reduction in children, and may also improve attention-deficit hyperactivity disorder symptoms.
RCT Entities:
OBJECTIVE: To determine whether pergolide, a mixed D1/D2/D3 dopamine agonist, is efficacious and safe in the treatment of children with chronic tic disorders and Tourette syndrome. BACKGROUND: Neuroleptics, which block dopamine transmission, are currently used to treat children with severe tics, but major side effects and limited efficacy reduce clinical utility. Prior open-label and crossover studies of pergolide suggest potential benefit. METHODS: The authors enrolled 57 children and adolescents, ages 7 to 17 years, randomizing them in a 2:1 ratio to either pergolide (0.15 to 0.45 mg per day) or placebo. Tic symptoms had to be >30 on the Yale Global Tic Severity Scale (YGTSS). The primary outcome measure was change in tic severity assessed by YGTSS. RESULTS: Compared to placebo treatment, pergolide treatment was associated with lower tic severity scores (treatment effect 8.8, pergolide vs placebo; 95% CI 0.1 to 17.6; p = 0.05) and attention-deficit hyperactivity disorder symptoms scores (treatment effect 3.8; 95% CI 0.7 to 6.8; p = 0.02). No patient had a serious adverse event and pergolide was well tolerated. CONCLUSIONS: In this randomized, placebo-controlled trial, pergolide appeared to be an efficacious and safe medication for tic reduction in children, and may also improve attention-deficit hyperactivity disorder symptoms.
Authors: James F Leckman; Michael H Bloch; Megan E Smith; Daouia Larabi; Michelle Hampson Journal: J Child Adolesc Psychopharmacol Date: 2010-08 Impact factor: 2.576
Authors: Lawrence Scahill; Douglas W Woods; Michael B Himle; Alan L Peterson; Sabine Wilhelm; John C Piacentini; Kevin McNaught; John T Walkup; Jonathan W Mink Journal: Mov Disord Date: 2013-05-16 Impact factor: 10.338
Authors: Sabine Wilhelm; Alan L Peterson; John Piacentini; Douglas W Woods; Thilo Deckersbach; Denis G Sukhodolsky; Susanna Chang; Haibei Liu; James Dziura; John T Walkup; Lawrence Scahill Journal: Arch Gen Psychiatry Date: 2012-08
Authors: Lawrence Scahill; Gerald Erenberg; Cheston M Berlin; Cathy Budman; Barbara J Coffey; Joseph Jankovic; Louise Kiessling; Robert A King; Roger Kurlan; Anthony Lang; Jonathan Mink; Tanya Murphy; Samual Zinner; John Walkup Journal: NeuroRx Date: 2006-04