An Investigation of PYM50028 a Novel Therapy for Parkinson's Disease

• Research type

  Research Study

• Full title

  A Phase II, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of Cogane™ (PYM50028), a Novel, Orally Active Neurotrophic Factor Inducer, in Male and Female Subjects with Early-Stage Parkinson’s Disease When Administered Once Daily for 28 Weeks

• IRAS ID

  61929

• Contact name

  Anthony Schapira

• Sponsor organisation

  Phytopharm Plc

• Eudract number

  2010-018534-44

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT01060878

• Research summary

  Parkinson's disease is the most common movement disorder (globally it is estimated to affect 120-180 per 100 000 of the population) and is a progressive, degenerative disorder. The development of a therapy that slows or stops disease progression and prevents the development of disability would represent a major advance in the treatment of Parkinson's disease. This study is being conducted to investigate the potential benefits and safety of a new drug in early stage Parkinson's Disease. PYM50028 (Cogane?½) is an orally bioavailable, small molecule with the ability to modulate neurotrophic factors (including GDNF and BDNF) which are essential for the survival, function and recovery of nerve cells. It is possible that these neurotrophic factors could slow or even reverse the progression of Parkinson's disease. PYM50028 has the advantage that, unlike the neurotrophic factors, it can be taken by mouth and transported through the blood-brain barrier into the brain. This study will enrol adult patients aged 35 to 75 years old (inclusive) who have been diagnosed with early-stage idiopathic Parkinson's disease. The study will be conducted at up to 75 sites globally, and at 9 centres in the UK. Participants will take PYM50028 daily for 28 weeks and will be on the study for approximately 34 weeks, during which time they will be required to visit their study doctor 10 times. At these visits, a number of assessments will be performed e.g. general physical examination, neurological examination, measurement of vital signs, ECG, collection of blood and urine samples for laboratory analysis, completion of questionnaires and assessments of quality of life, disease status and changes in mood and behaviour.Phytopharm plc is the sponsor of this study.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/75

• Date of REC Opinion

  22 Oct 2010

• REC opinion

  Favourable Opinion