Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease

Movement Disorders

Volumn 25, Issue 14, 2010, Pages 2326-2332

  Rascol, Olivier ^a   Barone, Paolo ^b   Hauser, Robert A ^c   Mizuno, Yoshikuni ^d   Poewe, Werner ^e   Schapira, Anthony H V ^f   Salin, Laurence ^g   Sohr, Mandy ^h   Debieuvre, Catherine ^g  

^a TOULOUSE UNIVERSITY HOSPITAL   (France)

^b UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^c UNIVERSITY OF SOUTH FLORIDA   (United States)

^d JUNTENDO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^e INNSBRUCK MEDICAL UNIVERSITY   (Austria)

^f UNIVERSITY COLLEGE LONDON   (United Kingdom)

^g BOEHRINGER INGELHEIM   (France)

^h BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Dopamine agonist; Parkinson's disease; Pramipexole extended release; Switch trial

Indexed keywords

LEVODOPA; PRAMIPEXOLE;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSAGE FORM COMPARISON; FATIGUE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA; PARKINSON DISEASE; PERIPHERAL EDEMA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; SUSTAINED DRUG RELEASE;

AGED; ANTIPARKINSON AGENTS; BENZOTHIAZOLES; CONFIDENCE INTERVALS; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MIDDLE AGED; PARKINSON DISEASE; SEVERITY OF ILLNESS INDEX; TIME FACTORS;

EID: 77958546617     PISSN: 08853185     EISSN: 15318257     Source Type: Journal    
DOI: 10.1002/mds.23262     Document Type: Article

References (25)

1. Holloway RG, Shoulson I, Fahn S, et al, on behalf of the Parkinson Study Group. Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial. Arch Neurol 2004; 61: 1044-1053.
2. Lieberman A, Ranhoski 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: 162-168.
3. Rascol O, Slaoui T, Regragui W, Ory-Magne F, Brefel-Courbon C, Montastruc JL. Dopamine agonists. Handbook of clinical neurology. In: Koller WC, Melamed E, editors, Parkinson's Disease and Related Disorders, Part II, Vol 84 (3rd series). Amsterdam, the Netherlands: Elsevier B.V; 2007: 73-92.
4. Grosset KA, Bone I, Grosset DG. Suboptimal medication adherence in Parkinson's disease. Mov Disord 2005; 20: 1502-1507.
5. Venton BJ, Zhang H, Garris PA, Phillips PE, Sulzer D, Wightman RM. Real-time decoding of dopamine concentration changes in the caudate-putamen during tonic and phasic firing. J Neurochem 2003; 87: 1284-1295.
6. Olanow CW, Obeso JA, Stocchi F. Continuous dopamine-receptor treatment of Parkinson's disease: scientific rationale and clinical implications. Lancet Neurol 2006; 5: 677-687.
7. Koenen-Bergmann M, Schepers C, Haertter S. A multiple rising-dose bioequivalence phase I study with a pramipexole extended release (ER) formulation [Abstract P1248]. Eur J Neurol 2008; 15( Suppl 3): 97.
8. Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology 1967; 17: 427-442.
9. Fahn S, Elton RL, and members of the UPDRS Development Committee. The Unified Parkinson's Disease Rating Scale. In: Fahn S, Marsden CD, Calne DB, Goldstein M, editors. Recent Developments in Parkinson's Disease. New York: Macmillan Healthcare Information; 1987. p 153-163.
10. Guttman M. Double-blind comparison of pramipexole and bromocriptine treatment with placebo in advanced Parkinson's disease.International Pramipexole-Bromocriptine Study Group. Neurology 1997; 49: 1060-1065.
11. Rinne UK, Bracco F, Chouza C, et al. Cabergoline in the treatment of early Parkinson's disease: results of the first year of treatment in a double-blind comparison of cabergoline and levodopa.The PKDS009 Collaborative Study Group. Neurology 1997; 48: 363-368.
12. Ziegler M, Castro-Caldas A, Del Signore S, Rascol O. Efficacy of piribedil as early combination to levodopa in patients with stable Parkinson's disease: a 6-month, randomized, placebo-controlled study. Mov Disord 2003; 18: 418-425.
13. National Institute of Mental Health (NIMH).Early clinical drug evaluation unit (ECDEU). Clinical Global Impressions. In: Guy W, editor. ECDEU Assessment Manual for Psychopharmacology, revised edition. Maryland: NIMH USA; 1976. p 216-222.
14. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991; 14: 540-545.
15. Christenson GA, Faber RJ, de Zwaan M, et al. Compulsive buying: descriptive characteristics and psychiatric comorbidity. J Clin Psychiatry 1994; 55: 5-11.
16. Grant JE, Levine L, Kim D, Potenza MN. Impulse control disorders in adult psychiatric inpatients. Am J Psychiatry 2005; 162: 2184-2188.
17. Adler CH, Sethi KD, Hauser RA, et al. Ropinirole for the treatment of early Parkinson's disease.The Ropinirole Study Group. Neurology 1997; 49: 393-399.
18. Korczyn AD, Brooks DJ, Brunt ER, Poewe WH, Rascol O, Stocchi F. Ropinirole versus bromocriptine in the treatment of early Parkinson's disease: a 6-month interim report of a 3-year study.053 Study Group. Mov Disord 1998; 13: 46-51.
19. Rascol O, Brooks DJ, Brunt ER, Korczyn AD, Poewe WH, Stocchi F. Ropinirole in the treatment of early Parkinson's disease: a 6-month interim report of a 5-year levodopa-controlled study.056 Study Group. Mov Disord 1998; 13: 39-45.
20. Barone P, Bravi D, Bermejo-Pareja F, et al. Pergolide monotherapy in the treatment of early PD: a randomized, controlled study.Pergolide Monotherapy Study Group. Neurology 1999; 53: 573-579.
21. Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A;Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord 2006; 21: 2110-2115.
22. Schrag A, Sampaio C, Counsell N, Poewe W. Minimal clinically important change on the unified Parkinson's disease rating scale. Mov Disord 2006; 21: 1200-1207.
23. Stocchi F, Hersh BP, Scott BL, Nausieda PA, Giorgi L;Ease-PD Monotherapy Study Investigators. Ropinirole 24-hour prolonged release and ropinirole immediate release in early Parkinson's disease: a randomized, double-blind, non-inferiority crossover study. Curr Med Res Opin 2008; 24: 2883-2895.
24. Rascol O. Defining a minimal clinically relevant difference for the Unified Parkinson's rating scale: an important but still unmet need. Mov Disord 2006; 21: 1059-1061.
25. Goetz CG, Tilley BC, Shaftman SR, et al; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord 2008; 23: 2129-2170.