Solvay 3005 - Open Label Study in Subjects with Advanced PD

• Research type

  Research Study

• Full title

  Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies.

• IRAS ID

  43146

• Contact name

  P Limousin

• Sponsor organisation

  Solvay Pharmaceuticals

• Eudract number

  2008-001329-33

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Parkinson's disease (PD) is a disease of the nervous system in which patients lose control of body movement. Clumsiness, slowed movements, being off balance and shaking can be the result of the loss of certain cells in the brain. Past studies have shown that the combination of the two medications, Levodopa and Carbidopa, can be highly effective in easing the symptoms of PD. However, after continuous use of Levodopa-Carbidopa, it may not work as well for patients over a long period of time.This study will examine Levodopa-Carbidopa in a gel form. The gel will be infused from a pump directly into the patients small intestine through a percutaneous endoscopic gastrostomy tube (called a PEG-J tube) passing through their stomach. The two active ingredients are supplied continuously. The goal of delivering the gel directly into the small intestine is to control PD symptoms more consistently than current oral medications might. This study is designed to continue to provide investigational levodopa-carbidopa intestinal gel treatment to those patients diagnosed with advanced Parkinson's disease that have participated in the open label treatment study (S187.3.003 or S187.3.004).

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  11/LO/0110

• Date of REC Opinion

  24 Feb 2011

• REC opinion

  Favourable Opinion