drugset / Trial / NCT00040404
Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease
Phase 2/3
Terminated
806 enrolled
Cephalon
H. Lundbeck A/S · collabThe Parkinson Study Group · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to establish safety for CEP-1347 and to determine an efficacious dose in the treatment of Parkinson's disease.
Timeline
- Start
- 2002-03
- Primary completion
- 2005-08
- Completion
- 2005-08
Outcome
Missed primary endpoint
Stopped: “Unlikely to provide evidence of significant effect”
paper Mixed lineage kinase inhibitor CEP-1347 fails to delay disability in early Parkinson disease. PMID 17881719 ↗
Publications
- Schwarzschild MA, Schwid SR, Marek K, Watts A, Lang AE, Oakes D, Shoulson I, Ascherio A; Parkinson Study Group PRECEPT Investigators; Hyson C, Gorbold E, Rudolph A, Kieburtz K, Fahn S, Gauger L, Goetz C, Seibyl J, Forrest M, Ondrasik J. Serum urate as a predictor of clinical and radiographic progression in Parkinson disease. Arch Neurol. 2008 Jun;65(6):716-23. doi: 10.1001/archneur.2008.65.6.nct70003. Epub 2008 Apr 14.
- Parkinson Study Group PRECEPT Investigators. Mixed lineage kinase inhibitor CEP-1347 fails to delay disability in early Parkinson disease. Neurology. 2007 Oct 9;69(15):1480-90. doi: 10.1212/01.wnl.0000277648.63931.c0. Epub 2007 Sep 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CEP1347 | Small molecule | 10 mg | — |
| Subject | CEP1347 | Small molecule | 25 mg | — |
| Subject | CEP1347 | Small molecule | 50 mg | — |