drugset / Trial / NCT02006121
Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment. The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.
Timeline
- Start
- 2014-03-03
- Primary completion
- 2016-06-06
- Completion
- 2017-06-08
Publications
- Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Lockhart D, Staines H, Lees A. Long-term safety and efficacy of apomorphine infusion in Parkinson's disease patients with persistent motor fluctuations: Results of the open-label phase of the TOLEDO study. Parkinsonism Relat Disord. 2021 Feb;83:79-85. doi: 10.1016/j.parkreldis.2020.12.024. Epub 2021 Jan 12.
- Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Spivey K, Vel S, Staines H, Lees A. Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2018 Sep;17(9):749-759. doi: 10.1016/S1474-4422(18)30239-4. Epub 2018 Jul 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Apomorphine | Unknown | 3 mg | Subcutaneous |
| Comparator | Apomorphine | Unknown | 8 mg | Subcutaneous |