drugset / Trial / NCT00474058
Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.
Timeline
- Start
- 2007-05
- Primary completion
- 2009-03
- Completion
- 2009-03
Publications
- Results Ghys L, Surmann E, Whitesides J, Boroojerdi B. Effect of rotigotine on sleep and quality of life in Parkinson's disease patients: post hoc analysis of RECOVER patients who were symptomatic at baseline. Expert Opin Pharmacother. 2011 Sep;12(13):1985-98. doi: 10.1517/14656566.2011.604031. Epub 2011 Jul 27.
- Kassubek J, Chaudhuri KR, Zesiewicz T, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Rotigotine transdermal system and evaluation of pain in patients with Parkinson's disease: a post hoc analysis of the RECOVER study. BMC Neurol. 2014 Mar 6;14:42. doi: 10.1186/1471-2377-14-42.
- Swick TJ, Friedman JH, Chaudhuri KR, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Associations between severity of motor function and nonmotor symptoms in Parkinson's disease: a post hoc analysis of the RECOVER Study. Eur Neurol. 2014;71(3-4):140-7. doi: 10.1159/000355019. Epub 2014 Jan 21.
- Trenkwalder C, Kies B, Rudzinska M, Fine J, Nikl J, Honczarenko K, Dioszeghy P, Hill D, Anderson T, Myllyla V, Kassubek J, Steiger M, Zucconi M, Tolosa E, Poewe W, Surmann E, Whitesides J, Boroojerdi B, Chaudhuri KR; Recover Study Group. Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord. 2011 Jan;26(1):90-9. doi: 10.1002/mds.23441. Epub 2010 Nov 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rotigotine | Unknown | 2 mg | Other |
| Subject | Rotigotine | Unknown | 4 mg | Other |
| Subject | Rotigotine | Unknown | 6 mg | Other |
| Subject | Rotigotine | Unknown | 8 mg | Other |
| Subject | Rotigotine | Unknown | 16 mg | Other |