Efficacy and safety of extended-versus immediate-release pramipexole in Japanese patients with advanced and L-dopa-undertreated Parkinson disease: A double-blind, randomized trial

Clinical Neuropharmacology

Volumn 35, Issue 4, 2012, Pages 174-181

  Mizuno, Yoshikuni ^a   Yamamoto, Mitsutoshi ^b   Kuno, Sadako ^c   Hasegawa, Kazuko ^d   Hattori, Nobutaka ^e   Kagimura, Tatsuro ^f   Sarashina, Akiko ^f   Rascol, Olivier ^g   Schapira, Anthony H V ^h   Barone, Paolo ⁱ   Hauser, Robert A ^j   Poewe, Werner ^k  

^a KITASATO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b KAGAWA PREFECTURAL CENTRAL HOSPITAL   (Japan)

^c Kyoto Sijyo Hospital   (Japan)

^d SAGAMIHARA NATIONAL HOSPITAL   (Japan)

^e JUNTENDO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f NIPPON BOEHRINGER INGELHEIM CO LTD   (Japan)

^g TOULOUSE UNIVERSITY HOSPITAL   (France)

^h UNIVERSITY COLLEGE LONDON   (United Kingdom)

ⁱ UNIVERSITY OF SALERNO   (Italy)

^j UNIVERSITY OF SOUTH FLORIDA   (United States)

^k INNSBRUCK MEDICAL UNIVERSITY   (Austria)

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Author keywords

bioequivalence; dyskinesia; extended release; immediate release; Parkinson disease; pramipexole; UPDRS

Indexed keywords

AMANTADINE; ENTACAPONE; LEVODOPA; PRAMIPEXOLE; SELEGILINE; THREO 3,4 DIHYDROXYPHENYLSERINE; TRIHEXYPHENIDYL;

ADULT; AGED; ANOREXIA; ARTICLE; CONSTIPATION; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSKINESIA; EXTENDED DRUG RELEASE; FALLING; FEMALE; HUMAN; IMMEDIATE DRUG RELEASE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; ORTHOSTATIC HYPOTENSION; PARKINSON DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SOMNOLENCE; STOMATITIS; UNIFIED PARKINSON DISEASE RATING SCALE; VISUAL HALLUCINATION;

AGED; AGED, 80 AND OVER; ASIAN CONTINENTAL ANCESTRY GROUP; BENZOTHIAZOLES; DELAYED-ACTION PREPARATIONS; DISORDERS OF EXCESSIVE SOMNOLENCE; DIZZINESS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG SUBSTITUTION; FEMALE; HUMANS; LEVODOPA; MALE; MIDDLE AGED; PARKINSON DISEASE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84863984844     PISSN: 03625664     EISSN: 1537162X     Source Type: Journal    
DOI: 10.1097/WNF.0b013e31825f77b9     Document Type: Article

References (16)

1. Fahn S. Description of Parkinson's disease as a clinical syndrome. Ann N Y Acad Sci 2003;991:1-14. (Pubitemid 36793796)
2. Holloway RG, Shoulson I, Fahn S, et al. Parkinson Study Group. Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial. Arch Neurol 2004;61(7):1044-1053. (Pubitemid 38915945)
3. Lieberman A, Ranhosky A, Korts D. Clinical evaluation of pramipexole in advanced Parkinson's disease: results of a double-blind, placebo-controlled, parallel-group study. Neurology 1997;49(1):162-168. (Pubitemid 27328697)
4. Mizuno Y, Yanagisawa N, Kuno S, et al. Japanese Pramipexole Study Group. Randomized, double-blind study of pramipexole with placebo and bromocriptine in advanced Parkinson's disease. Mov Disord 2003;18(10):1149-1156. (Pubitemid 37336939)
5. Möller JC, Oertel WH, Köster J, et al. Long-term efficacy and safety of pramipexole in advanced Parkinson's disease: results from a European multicenter trial. Mov Disord 2005;20(5):602-610. (Pubitemid 40862259)
6. Pinter MM, Pogarell O, Oertel WH. Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study. J Neurol Neurosurg Psychiatry 1999;66(4):436-441. (Pubitemid 29145676)
7. Grosset D, Antonini A, Canesi M, et al. Adherence to antiparkinson medication in a multicenter European study. Mov Disord 2009;24(6):826-832.
8. Nyholm D, Askmark H, Gomes-Trolin C, et al. Optimizing levodopa pharmacokinetics: intestinal infusion versus oral sustained-release tablets. Clin Neuropharmacol 2003;26(3):156-163. (Pubitemid 36676295)
9. Devos D. French DUODOPA Study Group. Patient profile, indications, efficacy and safety of duodenal levodopa infusion in advanced Parkinson's disease. Mov Disord 2009;24(7):993-1000.
10. Koenen-Bergmann M, Haertter S, Schepers C. A multiple rising-dose bioequivalence phase I study with a pramipexole extended release (ER) formulation. Eur J Neurol 2008;15 (Suppl 3):97-98. Abstract P1248.
11. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR (Text Revision). 4th ed. Arlington, VA: American Psychiatric Publishing, Inc; 2000.
12. Clinical Global Impressions. In: Guy W, ed. ECDEU Assessment Manual for Psychopharmacology, revised ed. Rockville, MD: National Institute of Mental Health, Early Clinical Drug Evaluation Unit; 1976:216-220.
13. Singer C, Lamb J, Ellis A, et al. Sumanirole for Early Parkinson's Disease Study Group. A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease. Mov Disord 2007;22(4):476-482. (Pubitemid 46608143)
14. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991;14(6):540-545.
15. Gough K, Hutchison M, Keene O, et al. Assessment of dose proportionality: report from the statisticians in the pharmaceutical industry/pharmacokinetic UK joint working party. Drug Inf J 1995;29:1039-1048.
16. Kimura H, Kurimura M, Wada M, et al. Female preponderance of Parkinson's disease in Japan. Neuroepidemiology 2002;21(6):292-296. (Pubitemid 36151500)