Study of NP031112 in Patients with Mild to Moderate PSP.

• Research type

  Research Study

• Full title

  A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112, a GSK-3 Inhibitor, Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy

• IRAS ID

  28544

• Eudract number

  2009-013097-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is being carried out to see if NP031112 is effective, safe and well tolerated in treating Progressive Supranuclear Palsy (PSP). NP031112 is an experimental medicine which is taken as a suspension in water. It is made by Noscira S.A. who are sponsoring this study. Our study will include patients who have mild to moderate PSP and who are aged 40 to 85. 140 patients will be invited to join the study in total, we expect approximately 30 of these patients will be in the UK. The patient will take the study drug once a day in the morning before breakfast for 52 weeks and wait 1 hour afterward before eating. This study is a double blinded trial and that means that neither the patient nor the study doctor will know if the patient is taking active drug or placebo. The patient will have a screening period to determine if they can enter the trial then there will be 9 more visits throughout the study so that the doctor can check their progress. We will monitor the patients for side effects throughout the trial. There will be 2 optional parts of the trial that patients can choose to do (they can choose one or both or neither). The first option is to have 2 additional MRI scans and the second option is to have some Cerebrospinaflud samples taken during a lumbar puncture. The scientific reason for developing NP031112 is based on the Tau protein. Abnormal changes in this protein are considered one of the primary causes of Alzheimer??s disease and other brain disorders such as PSP. A protein in the body called GSK-3 is thought to be responsible for some of these changes. The drug under investigation inhibits the activity of GSK-3 and is intended for treatment of these diseases.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  09/H0907/60

• Date of REC Opinion

  30 Oct 2009

• REC opinion

  Further Information Favourable Opinion