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Long-term open-label study of pramipexole in patients with primary restless legs syndrome.
J Neurol Sci. 2010 Jul 15; 294(1-2):62-6.JN

Abstract

A phase III, open-label, long-term clinical study was performed to evaluate the safety and efficacy of pramipexole in a cohort of 141 Japanese patients with primary restless legs syndrome (RLS). The patients were started on pramipexole 0.25 mg/day and were subsequently maintained on that dose or switched to 0.125, 0.5, or 0.75 mg/day to achieve optimal efficacy and tolerability. The International Restless Legs Syndrome Study Group Rating Scale for restless legs syndrome (IRLS) score improved from 22.3+/-4.7 at baseline to 11.1+/-7.7 at week 8 and 4.9+/-5.9 at week 52. IRLS responders, defined as patients whose IRLS total score decreased by > or =50% from baseline, accounted for 67.4% at week 12 and 86.6% at week 52. Over 90% of patients were Clinical Global Impression-global improvement (CGI-I) and Patient Global Impression (PGI) responders. The Pittsburgh Sleep Quality Index (PSQI) score decreased from 7.9+/-3.1 at baseline to 4.6+/-2.9 at week 52. Similarly, the Japanese version of the Epworth Sleepiness Scale score decreased from 9.3+/-5.2 to 4.9+/-3.8. Baseline IRLS score < or =20 was significantly associated with a complete IRLS response in this long-term study. Adverse events were typical of nonergot dopamine agonists, mild in intensity, and decreased in frequency as the study progressed. RLS augmentation was not observed. Pramipexole 0.25-0.75 mg/day is efficacious, safe, and well tolerated in patients with RLS. Pramipexole showed good efficacy, particularly in patients with an IRLS total score <20.

Authors+Show Affiliations

Japan Somnology Center, Neuropsychiatric Research Institute, Shibuya-ku, Tokyo, Japan. inoue@somnology.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20451927

Citation

Inoue, Yuichi, et al. "Long-term Open-label Study of Pramipexole in Patients With Primary Restless Legs Syndrome." Journal of the Neurological Sciences, vol. 294, no. 1-2, 2010, pp. 62-6.
Inoue Y, Kuroda K, Hirata K, et al. Long-term open-label study of pramipexole in patients with primary restless legs syndrome. J Neurol Sci. 2010;294(1-2):62-6.
Inoue, Y., Kuroda, K., Hirata, K., Uchimura, N., Kagimura, T., & Shimizu, T. (2010). Long-term open-label study of pramipexole in patients with primary restless legs syndrome. Journal of the Neurological Sciences, 294(1-2), 62-6. https://doi.org/10.1016/j.jns.2010.04.003
Inoue Y, et al. Long-term Open-label Study of Pramipexole in Patients With Primary Restless Legs Syndrome. J Neurol Sci. 2010 Jul 15;294(1-2):62-6. PubMed PMID: 20451927.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term open-label study of pramipexole in patients with primary restless legs syndrome. AU - Inoue,Yuichi, AU - Kuroda,Kenji, AU - Hirata,Koichi, AU - Uchimura,Naohisa, AU - Kagimura,Tatsuo, AU - Shimizu,Tetsuo, Y1 - 2010/05/07/ PY - 2009/09/18/received PY - 2010/04/06/revised PY - 2010/04/07/accepted PY - 2010/5/11/entrez PY - 2010/5/11/pubmed PY - 2010/10/22/medline SP - 62 EP - 6 JF - Journal of the neurological sciences JO - J. Neurol. Sci. VL - 294 IS - 1-2 N2 - A phase III, open-label, long-term clinical study was performed to evaluate the safety and efficacy of pramipexole in a cohort of 141 Japanese patients with primary restless legs syndrome (RLS). The patients were started on pramipexole 0.25 mg/day and were subsequently maintained on that dose or switched to 0.125, 0.5, or 0.75 mg/day to achieve optimal efficacy and tolerability. The International Restless Legs Syndrome Study Group Rating Scale for restless legs syndrome (IRLS) score improved from 22.3+/-4.7 at baseline to 11.1+/-7.7 at week 8 and 4.9+/-5.9 at week 52. IRLS responders, defined as patients whose IRLS total score decreased by > or =50% from baseline, accounted for 67.4% at week 12 and 86.6% at week 52. Over 90% of patients were Clinical Global Impression-global improvement (CGI-I) and Patient Global Impression (PGI) responders. The Pittsburgh Sleep Quality Index (PSQI) score decreased from 7.9+/-3.1 at baseline to 4.6+/-2.9 at week 52. Similarly, the Japanese version of the Epworth Sleepiness Scale score decreased from 9.3+/-5.2 to 4.9+/-3.8. Baseline IRLS score < or =20 was significantly associated with a complete IRLS response in this long-term study. Adverse events were typical of nonergot dopamine agonists, mild in intensity, and decreased in frequency as the study progressed. RLS augmentation was not observed. Pramipexole 0.25-0.75 mg/day is efficacious, safe, and well tolerated in patients with RLS. Pramipexole showed good efficacy, particularly in patients with an IRLS total score <20. SN - 1878-5883 UR - https://www.unboundmedicine.com/medline/citation/20451927/Long_term_open_label_study_of_pramipexole_in_patients_with_primary_restless_legs_syndrome_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-510X(10)00162-0 DB - PRIME DP - Unbound Medicine ER -