A head-to-head trial with
oral IR CD/LD

Study Design1-3

VYALEV was studied in a phase 3, 12-week, randomized, double-blind, double-dummy, active-controlled, multicenter study in patients with advanced PD. In the study, 141 levodopa-responsive patients were randomized 1:1 and received either 24-hour/day continuous subcutaneous administration of VYALEV plus oral placebo capsules (n=74) or 24-hour/day continuous subcutaneous administration of placebo solution plus oral encapsulated IR carbidopa/levodopa tablets (n=67).*†‡

Oral IR CD/LD Stabilization Period (14-21 Days)

All LD-containing medications and COMT inhibitors were converted to an IR CD/LD dose.

7-14 Days of Stabilization
+ 7 Days of No Change

R.

Double-blind Treatment Period (12 Weeks)

VYALEV Treatment Group (n=74)§:
VYALEV + Oral Placebo Capsules

28-day VYALEV Optimization Phase||

56-day
Maintenance Phase

Oral IR CD/LD Treatment Group (n=67)§:
Oral Encapsulated IR CD/LD + CSCI Placebo Solution

28-day Placebo CSCI Optimization Phase||

56-day
Maintenance Phase

*Analyzed by mixed model for repeated measures (MMRM).2

†Of the 141 patients who were randomly assigned in the trial, 110 completed the study. Of the 74 patients randomized to receive VYALEV, 48 completed the study and 26 discontinued treatment. Of the 67 patients randomized to receive oral IR CD/LD, 62 completed the study and 5 discontinued treatment.2

‡Study population included levodopa-responsive PD patients whose motor fluctuations were inadequately controlled by their current medications and who experienced a minimum of 2.5 hours of “Off” time per day as assessed using a PD diary. Daily normalized "Off" and "On" times are averaged over valid PD diary days for each visit to obtain the average daily normalized times.1

§Concomitant PD medications were allowed during the study; however, no changes were permitted. Use of rescue oral IR CD/LD was allowed.2

||Doses of VYALEV and placebo CSCI were titrated only during the Optimization Phase.2

Endpoints1

Primary endpoint

Mean change from baseline to week 12 in total daily mean “On” time without troublesome dyskinesia

Key secondary endpoint

Mean change from baseline to week 12 in total daily mean “Off” time

Endpoints were normalized to a daily 16-hour awake period and averaged over valid PD diary days for each visit.

“On” time without troublesome dyskinesia was defined as the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia.1

Key eligibility criteria3

Select inclusion criteria:

  • ≥30 years old
  • Diagnosed with levodopa-responsive idiopathic PD
  • Currently taking ≥400 mg/day of LD equivalents (from LD-containing medications and COMT inhibitors)
  • Motor fluctuations that were inadequately controlled with current therapy
  • Minimum daily average “Off” time of 2.5 hours per day as assessed using a PD diary
  • MMSE score ≥24

Select exclusion criteria:

  • Low vitamin B12 level (<200 pg/mL) or low-normal vitamin B12 level (<300 pg/mL) with elevated methylmalonic acid (MMA >0.41 μmol/L)#
  • Received DBS, CD/LD enteral suspension, or any other PD medication as a continuous daily infusion
  • History of significant skin conditions or disorders**

#Retesting was allowed during the screening period.4

**Including psoriasis, atopic dermatitis or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that would interfere with treatment.3

With VYALEV, more “On” time without troublesome dyskinesia may be possible.1

Explore efficacy results

CD=carbidopa; COMT=catechol-O-methyltransferase; CSCI=continuous subcutaneous infusion; DBS=deep brain stimulation; IR=immediate release; LD=levodopa; MMSE=Mini-Mental State Examination; PD=Parkinson’s disease.