Safinamide in Parkinson's disease-Settle Open Label Extension Study

• Research type

  Research Study

• Full title

  Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson’s Disease Patients

• IRAS ID

  33197

• Contact name

  David Burn

• Sponsor organisation

  Sponsor UK Contact: Quintiles.ltd

• Eudract number

  2008-005492-94

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The 28850 trial is an open label extension to the current active 27919 Parkinson's Disease trial (PD). This is a 3-year, single arm, open-label, multi-center, multinational trial of Safinamide (50-100 mg/day) in subjects which have completed the previous safinamide clinical study (27919) and who meet all inclusion/exclusion criteria.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  09/H0907/72

• Date of REC Opinion

  9 Dec 2009

• REC opinion

  Further Information Favourable Opinion