What is documented about the use of Sifrol (pramipexole) for restless legs in children?/nA 14-year-

Fråga: What is documented about the use of Sifrol (pramipexole) for restless legs in children?

A 14-year-old otherwise healthy boy has a pronounced problem with restless legs, especially in the evenings.

Sammanfattning: We found only two case reports concerning pramipexole treatment of restless legs or parasomnia in children in the literature. A clinical improvement was documented in both cases.

Svar: Pramipexole is a dopamine receptor agonist often given in combination with levodopa as symtomatic treatment for Parkinsons disease. The drug has high affinity to Dopamin D3, D2-receptors, resulting in improved motor function through dopamin receptor stimulation. Pramipexole is mainly excreted unchanged in the urine (1). Pramipexol has documented effect in the treatment of restless legs in adults (2-5). However, it is not considered to be a first line treatment, based on available data. There is limited documentation concerning its use in children. In one study, 84 children (mean 6.85 years, range 2.1-11) with different treatment for parasomnia were observed. Two children, one with restless legs syndrome (RLS) and one with RLS and periodic limb movement syndrome (PLMD), were treated with pramipexole, 0.125 and 0.25 mg, respectively, at bedtime. A clinical improvement, measured as a reduced number of EEG arousals associated with periodic limb movement per hour, was observed in both children at a six month follow up (6).

The onset of idiopathic RLS can begin at any age, even in infancy and early childhood (7,8). However, no general prevalence data for RLS or PLMD in children, are available. In one study, the prevalence of RLS was found to be 2.7% (95% CI 1.9-3.5) and for PLMD 3.2% (95% CI 2.3-4.1) in teenagers (15-19 years) (9). In children or adolescent RLS can be misdiagnosed as growing pains or hyperactivity disorders (7,10).

No precise etiology for RLS or PLMD is known, but some evidence suggests a central nervous system dysfunction, with involvement of dopaminergic pathways (7). This is supported by an observed improved condition after treatment with dopaminergic agents, dopamine precursors or dopamine agonists such as pramipexole (7,11). 1 FASS 2002 (The Swedish catalogue of approved medical products)

2 Drugline no 18807 (year 2002)
3 Drugline no 18631 (year 2001)
4 Drugline no 18703 (year 2001)

5 Montplaisir J, Denesle R, Petit D. Pramipexole in the treatment of restless legs syndrome: a follow-up study. Eur J Neurol 2000;7(suppl 1):27-31. 6 Guilleminault C, Palombini L, Pelayo R, Chervin RD. Sleepwalking and sleep terrors in prepubertal children: what triggers them? Pediatrics 2003;111:17-25. 7 Glasauer FE. Restless legs syndrome. Spinal Cord 2001;39:125-33. 8 Walters AS, Picchietti DL, Ehrenberg BL, Wagner ML. Restless legs syndrome in childhood and adolescence. Pediatr Neurol 1994;11:241-5. 9 Ohayon MM, Roth T. Prevalence of restless legs syndrome and periodic limb movement disorder in the general population. J Psychosom Res 2002;53:547-54. 10 Drugline no 08746 (year 1992) 11 Walters AS, Mandelbaum DE, Lewin DS, Kugler S, England SJ, et al. Dopaminergic therapy in children with restless legs/periodic limb movements in sleep and ADHD. Pediatr Neurol 2000;22:182-6.