Tic reduction with pergolide in a randomized controlled trial in children

• Published in: Neurology Vol. 60; no. 4; pp. 606 - 611
• Main Authors: GILBERT, D. L, DURE, L, SETHURAMAN, G, RAAB, D, LANE, J, SALLEE, F. R
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 25-02-2003
• Subjects: Adolescent; Attention Deficit Disorder with Hyperactivity - drug therapy; Biological and medical sciences; Catecholaminergic system; Child; Chronic Disease; Dopamine Agonists - adverse effects; Dopamine Agonists - therapeutic use; Electrocardiography - drug effects; Female; Gastrointestinal Diseases - chemically induced; Headache - chemically induced; Humans; Male; Medical sciences; Neuropharmacology; Neurotransmitters. Neurotransmission. Receptors; Pergolide - adverse effects; Pergolide - therapeutic use; Pharmacology. Drug treatments; Safety; Severity of Illness Index; Sleep Initiation and Maintenance Disorders - chemically induced; Tic Disorders - drug therapy; Tourette Syndrome - drug therapy; Treatment Outcome; Human; Nervous system diseases; Agonist; Prognosis; Hyperactivity; Dopamine receptor; Low dose; Ergot derivatives; Crossover study; Cerebral disorder; Involuntary movement; Tic; Chemotherapy; Pergolide; Randomization; Attentional disorder; Treatment; Central nervous system disease; Dopamine agonist; Gilles de la Tourette syndrome; Degenerative disease; Child
• ISSN: 0028-3878; 1526-632X
• DOI: 10.1212/01.WNL.0000044058.64647.7E

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.
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.
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.
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.
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.