Tic reduction with pergolide in a randomized controlled trial in children.
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.
Gilbert
D L
DL
Division of Neurology, Cincinnati Children's Hospital Medical Center, OH 45229-3039, USA. d.gilbert@chmcc.org
Dure
L
L
Sethuraman
G
G
Raab
D
D
Lane
J
J
Sallee
F R
FR
D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D002908:Chronic Disease; D018491:Dopamine Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D010479:Pergolide / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D013981:Tic Disorders / Q000188:drug therapy*; D005879:Tourette Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome
D018491:Dopamine Agonists; D010479:Pergolide