Status:
Not Yet Recruiting
Clinicaltrials.gov identifier:
Sponsor:
University College London
Enrollment:
200
Study Design:
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.
Rationale:
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.
Comments:
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.
