Open, Safety and Efficacy of Levodopa-Carbidopa in Advanced Parkinsons

• Research type

  Research Study

• Full title

  An open-label, 12 month safety and efficacy study of levodopa-carbidopa intestinal gel in levodopa-responsive subjects with advanced Parkinson’s disease and severe motor-fluctuations despite optimized treatment with available Parkinson’s disease medications

• Sponsor organisation

  Solvay Pharmaceuticals BV.

• Eudract number

  2006-005186-18

• ISRCTN Number

  .

• Clinicaltrials.gov Identifier

  .

• Research summary

  Solvay Pharmaceuticals, B.V. is carrying out this study to find out how well an investigational medication and delivery system works as treatment for advanced Parkinson's disease (PD). This includes “levodopa-carbidopa intestinal gel” and a pump and tubing. Levodopa-carbidopa intestinal gel is approved for use in many countries in Europe as Duodopa©. Solvay will use the information from this study in its application to the United States Food and Drug Administration (US FDA) in order to allow the medication to be used for the treatment of Parkinson’s Disease in patients in the US. Past studies have shown that the combination of the two common PD 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 over a long period of time. The active ingredients of the study medication are levodopa and carbidopamonohydrate. The other ingredients are carmellose sodium and purified water. Levodopa is transformed in the body to dopamine, a substance present in the brain and in the spinal cord where it assists in the transfer of impulses between the nerve cells. Too little dopamine can give symptoms like those in Parkinson’s disease, for example tremor, rigidity, slow movements, difficulty keeping one’s balance. The treatment with levodopa increases the amount of dopamine and hence reduces these symptoms. Carbidopa is added to improve the effect and reduce the undesirable effects of levodopa. This study will examine these medications in a gel form. The gel will be infused from a pump directly into the small intestine through a percutaneous endoscopic gastrostomy tube (called a PEG-J tube) passing through the stomach. Levodopa and carbidopa are infused continuously. The goal of delivering the gel directly into the intestine is to control PD symptoms more consistently than current available medications might.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  08/H0716/55

• Date of REC Opinion

  19 Nov 2008

• REC opinion

  Further Information Favourable Opinion