Not Yet Recruiting
University College London
A randomised, double-blind, placebo-controlled, parallel group study run at a single centre. The active drug is a 2mg, self-administered, sub-cutaneous injection with a 2-year treatment period.
The primary outcome measure is change in the motor function as measured by MDS-UPDRS part 3 in the OFF state between baseline and 96 weeks. Secondary outcome measures are: 1. MDS-UPDRS parts 1,2 and 4 in the ON state; 2. Timed walk assessment both ON and OFF; 3. Montreal cognitive assessment (MOCA); 4. Unified dyskinesia rating scale (UDysRS); 5. Patient health questionnaire-9 (PHQ-9); 6. PD quality of life (PDQ-39); 7. Non-motor symptoms scale (NMSS); 8. Levodopa equivalent dose (LED); 9. Hauser diary (3 day) of PD state; 10. Safety and tolerability. These assessments will also be done at baseline and 96 weeks.
The inclusion criteria are for PwP between the ages of 25 and 80 who are already on dopaminergic therapy. The Hoehn and Yahr stage must be <2.5 in the ON state, thus excluding more advanced patients. Given the comparatively slow degeneration rate in PD, the treatment period of almost 2 years is a positive feature of this study. The success of the trial does, however, assume that the same rate of increase in UPDRS scores in the placebo group seen in the 48-week period in the previous studies will continue over 96 weeks in this one. This study should also show whether the positive impact of exenatide treatment on MDS-UPDRS scores seen in prior work is a short-lived effect that dissipates with time, simply delaying a return to an expected rate of decline; or if the extended treatment may slow a further decline in disability, thus meeting the real need for people with PD, a medicine that slows the progressive development of symptoms.