Newron phase 1 study treating patients with Parkinson's Disease
Research type
Research Study
Full title
A phase 1, multicentre, randomised, double-blind study to assess safety and tolerability of repeated intracerebroventricular administration of sNN0031 infusion solution to patients with Parkinson’s disease
IRAS ID
145958
Contact name
K Ray Chaudhuri
Contact email
Sponsor organisation
Newron Sweden AB
Eudract number
2012-000107-32
Research summary
The purpose of this trial is to evaluate the tolerability and safety of a new treatment for Parkinson’s disease. Twenty patients will be recruited over five hospitals in Europe, two in Sweden (Lund and Stockholm), two in the UK (London and Oxford) and one in Germany (Bremerhaven).
The study drug (sNN0031) is a growth factor called PDGF-BB, that will be administered directly into the fluid-filled cavities in the brain via a pump infusion system with two treatment periods over three and a half months. The drug is produced by the Swedish biopharmaceutical company Newron Sweden AB who sponsor this study.
The study drug, sNN0031 is a protein, a growth factor known as PDGF-BB, which is found naturally in the body. One function of PDGF-BB is to promote wound healing and it plays a role in the formation of new blood vessels. In laboratory tests, it has been shown that it can stimulate renewal of nerve cells and other brain cells, which could lead to improvement in diseases caused by destruction of nerve cells, such as Parkinson’s disease. In animal models of Parkinson’s disease, delivery of sNN0031 infusion solution (PDGF-BB) to one of the fluid filled cavities in the brain resulted in an improvement in motor symptoms.
The pump infusion system are currently in routine use to administer drugs into the spinal cord region in patients diagnosed with other diseases of the central nervous system. The pump system is not approved for use with sNN0031 infusion solution for Parkinson’s disease as an indication. One aim of the study is to obtain data for approval.
REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/1125
Date of REC Opinion
22 Oct 2014
REC opinion
Further Information Favourable Opinion