PYM50028: multi dose study in volunteers and Parkinson's patients

• Research type

  Research Study

• Full title

  A randomised, double-blind, multiple dose-ascending, placebo-controlled study in healthy volunteers and Parkinson’s disease patients to assess the safety, tolerability and pharmacokinetics of daily oral administration of PYM50028 (Cogane™) over one month

• IRAS ID

  9968

• Sponsor organisation

  Phytopharm plc.

• Eudract number

  2008-005938-71

• ISRCTN Number

  N/A

• Research summary

  The study treatment, Cogane?½ has been shown in preclinical studies to reverse the changes in the area of the brain involved in Parkinson's Disease by inducing the body's own production of proteins known as neurotrophic factors. In addition, preclinical studies have suggested that Cogane?½ reduces the Parkinson's disability and increases muscle strength and coordination.Cogane?½ has been shown to be safe and well tolerated when given orally to healthy human adults and patients with Alzheimer??s disease. The sponsor (Phytopharm plc) has now developed an oral formulation of Cogane?½ that's more suitable for the patient population and for dosing over longer periods of time. Healthy human volunteers and Parkinson's patients participation in the study; involving visits to the clinic at LCG Bioscience will be about 9 days over a period of approximately 10 weeks.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/21

• Date of REC Opinion

  31 Mar 2009

• REC opinion

  Further Information Favourable Opinion