Subcutaneous Levodopa infusion in Parkinson's Disease. V1,19Dec2011

• Research type

  Research Study

• Full title

  Proof of concept trial for subcutaneous Levodopa in Parkinson's disease

• IRAS ID

  41064

• Contact name

  Thomas Warner

• Sponsor organisation

  UCL, Joint Research Office

• Eudract number

  2011-000200-18

• Research summary

  Levodopa has been the gold standard for treatment in Parkinson's disease for many years, but its long-term use is complicated motoflutuations including freezing and abnormal involuntary movements (dyskinesias) due tflutuating levels of levodopa in the blood when taken orally. A more controlled, continuous Levodopa administration in a subcutaneous (under the skin) infusion should result in less variation in plasma levels and more stable clinical responses. However, Levodopa has poor solubility and there is not currently available a commercial product for subcutaneous infusion. We have developed an innovative Levodopa solution and thus aim to conduct the trial with this drug. The drug has been tested in a pre-clinical rodent study demonstrating successful administration via the subcutaneous route. The proposed trial of subcutaneous Levodopa infusion will be conducted in 6-8 symptomatic Parkinson's disease patients whose current treatment regimen does not fully control their symptoms. The primary objective is to assess the safety and tolerability of this mode of administration of the drug. The secondary objective is to assess the clinical efficacy of the subcutaneous infusion, which will be measured using established clinical rating scales for Parkinson's disease. We will also measure the pharmacokinetics of Levodopa subcutaneous infusion through Levodopa plasma level measurements. If the trial demonstrates clinical efficacy and successful delivery of the drug via the subcutaneous route, we plan to patent the innovation and conduct future studies.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/0169

• Date of REC Opinion

  14 Mar 2012

• REC opinion

  Further Information Favourable Opinion