drugset / Trial / NCT02702076
Apomorphine in Parkinson's Disease Patients With Visual Hallucinations
RandomizedParallel-groupTriple-blindTreatment
Summary
This randomised, double-blind, placebo-controlled trial will evaluate the efficacy of continuous apomorphine infusion compared to placebo in PD patients with visual hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.
Timeline
- Start
- 2017-05
- Primary completion
- 2017-12
- Completion
- 2017-12
Publications
- Results van Laar T, Postma AG, Drent M. Continuous subcutaneous infusion of apomorphine can be used safely in patients with Parkinson's disease and pre-existing visual hallucinations. Parkinsonism Relat Disord. 2010 Jan;16(1):71-2. doi: 10.1016/j.parkreldis.2009.05.006. Epub 2009 Jun 12. No abstract available.
- Results Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
- Results Fenelon G, Alves G. Epidemiology of psychosis in Parkinson's disease. J Neurol Sci. 2010 Feb 15;289(1-2):12-7. doi: 10.1016/j.jns.2009.08.014. Epub 2009 Sep 8.
- Results Goetz CG, Ouyang B, Negron A, Stebbins GT. Hallucinations and sleep disorders in PD: ten-year prospective longitudinal study. Neurology. 2010 Nov 16;75(20):1773-9. doi: 10.1212/WNL.0b013e3181fd6158. Epub 2010 Oct 20.
- Results Gallagher DA, Parkkinen L, O'Sullivan SS, Spratt A, Shah A, Davey CC, Bremner FD, Revesz T, Williams DR, Lees AJ, Schrag A. Testing an aetiological model of visual hallucinations in Parkinson's disease. Brain. 2011 Nov;134(Pt 11):3299-309. doi: 10.1093/brain/awr225. Epub 2011 Sep 15.
- Results Borgemeester RW, Drent M, van Laar T. Motor and non-motor outcomes of continuous apomorphine infusion in 125 Parkinson's disease patients. Parkinsonism Relat Disord. 2016 Feb;23:17-22. doi: 10.1016/j.parkreldis.2015.11.013. Epub 2015 Nov 22.
- Results Garcia Ruiz PJ, Sesar Ignacio A, Ares Pensado B, Castro Garcia A, Alonso Frech F, Alvarez Lopez M, Arbelo Gonzalez J, Baiges Octavio J, Burguera Hernandez JA, Calopa Garriga M, Campos Blanco D, Castano Garcia B, Carballo Cordero M, Chacon Pena J, Espino Ibanez A, Gorospe Onisalde A, Gimenez-Roldan S, Granes Ibanez P, Hernandez Vara J, Ibanez Alonso R, Jimenez Jimenez FJ, Krupinski J, Kulisevsky Bojarsky J, Legarda Ramirez I, Lezcano Garcia E, Martinez-Castrillo JC, Mateo Gonzalez D, Miquel Rodriguez F, Mir P, Munoz Fargas E, Obeso Inchausti J, Olivares Romero J, Olive Plana J, Otermin Vallejo P, Pascual Sedano B, Perez de Colosia Rama V, Perez Lopez-Fraile I, Planas Comes A, Puente Periz V, Rodriguez Oroz MC, Sevillano Garcia D, Solis Perez P, Suarez Munoz J, Vaamonde Gamo J, Valero Merino C, Valldeoriola Serra F, Velazquez Perez JM, Yanez Bana R, Zamarbide Capdepon I. Efficacy of long-term continuous subcutaneous apomorphine infusion in advanced Parkinson's disease with motor fluctuations: a multicenter study. Mov Disord. 2008 Jun 15;23(8):1130-6. doi: 10.1002/mds.22063.
- Results Martinez-Martin P, Reddy P, Antonini A, Henriksen T, Katzenschlager R, Odin P, Todorova A, Naidu Y, Tluk S, Chandiramani C, Martin A, Chaudhuri KR. Chronic subcutaneous infusion therapy with apomorphine in advanced Parkinson's disease compared to conventional therapy: a real life study of non motor effect. J Parkinsons Dis. 2011;1(2):197-203. doi: 10.3233/JPD-2011-11037.
- Results Martinez-Martin P, Reddy P, Katzenschlager R, Antonini A, Todorova A, Odin P, Henriksen T, Martin A, Calandrella D, Rizos A, Bryndum N, Glad A, Dafsari HS, Timmermann L, Ebersbach G, Kramberger MG, Samuel M, Wenzel K, Tomantschger V, Storch A, Reichmann H, Pirtosek Z, Trost M, Svenningsson P, Palhagen S, Volkmann J, Chaudhuri KR. EuroInf: a multicenter comparative observational study of apomorphine and levodopa infusion in Parkinson's disease. Mov Disord. 2015 Apr;30(4):510-6. doi: 10.1002/mds.26067. Epub 2014 Nov 10.
- Results Ellis C, Lemmens G, Parkes JD, Abbott RJ, Pye IF, Leigh PN, Chaudhuri KR. Use of apomorphine in parkinsonian patients with neuropsychiatric complications to oral treatment. Parkinsonism Relat Disord. 1997 Apr;3(2):103-7. doi: 10.1016/s1353-8020(97)00009-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apomorphine | Unknown | 1 mg | Subcutaneous |