Efficacy and safety of BIA 9-1067 in idiopathic parkinsons disease

• Research type

  Research Study

• Full title

  Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with “wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group,multicentre clinical study.

• IRAS ID

  69725

• Contact name

  Andrew Lees

• Sponsor organisation

  BIAL - Portela & C, S.A

• Eudract number

  2010-022366-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Parkinson's disease (PD) is a neurodegenerative disorder with an estimated incidence of 4.5 to 16 per 100, 000 persons per year. PD affects approximately 1% of people over the age of 60. The main purpose of this study is to investigate the efficacy of 2 different doses of BIA 9-1067 (25 mg and 50 mg),administered once a day, compared with placebo when administered with the existing treatment of L-DOPA plus a dopa decarboxylase inhibitor (DDCI), in patients with PD and end-of-dose motoflutuations. The second objective of this study is to investigate the safety and tolerability of BIA 9-1067 or placebo in addition to the existing treatment of L-DOPA/DDCI Patients will be entered in one of 3 treatment groups: Two BIA 9-1067 groups, each receiving either 25 mg or 50 mg daily and a placebo group. Patients will be in the study for up to 71 weeks. After the double-blind period is finished (up to 15 weeks), patients will have the option to continue in a 1 year extension (open-label period) in which all patients will receive BIA 9-1067. Patients may stay on the study until their disease has become worse, they develop an unacceptable side effect, are no longer able to participate, or decide they no longer want to continue in the study. The trial, funded by the Pharmaceutical company BIAL, will be completed in 12 countries: Estonia, India, Israel, Korea, Russia, S.Africa and UK. Other countries may also participate in this study. Approximately 405 subjects are to be entered in the study; 135 patients is expected to enter each treatment group.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  11/H0502/13

• Date of REC Opinion

  23 Mar 2011

• REC opinion

  Further Information Favourable Opinion