CERE-120 with Best Medical Therapy (BMT) v BMT in Parkinson's Disease

  • Research type

    Research Study

  • Full title

    A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2-Neurturin) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease

  • IRAS ID

    1867

  • Contact name

    Patricia Limousin

  • Contact email

    p.limousin@ion.ucl.ac.uk

  • Sponsor organisation

    Ceregene, Inc.

  • Eudract number

    2007-006721-27

  • ISRCTN Number

    N/A

  • Clinicaltrials.gov Identifier

    N/A

  • Research summary

    The purpose of this study is firstly to see if an experimental drug called CERE-120 is safe when given to people with Parkinson’s disease and secondly to see whether CERE-120 can improve symptoms of Parkinson’s disease . The CERE-120 drug is injected via surgery into small areas of the brain. CERE-120 is made by combining a virus called AAV (adeno-associated virus) that is modified with a gene that makes a protein called neurturin. Once injected in the brain, CERE-120 will get into the brain cells and produce neurturin. Neurturin produced in these cells can help these and other cells around the site of injection, including brain cells that produce dopamine, to become or remain healthy. The company that is developing CERE-120 is called Ceregene, Incorporated.

  • REC name

    London - West London & GTAC Research Ethics Committee

  • REC reference

    GTAC159

  • Date of REC Opinion

    13 Jan 2009

  • REC opinion

    Further Information Favourable Opinion