AI-generated depiction. Not a real patient.
TEMPO-3 (with oral levodopa)
Patients experienced significantly more good “On” time* with JUVMO added to oral LD vs oral LD alone1,2
Primary endpoint: Change from baseline to week 26 in total daily good "On" time*
Pinch to zoom
TEMPO-3: Phase 3, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose, 27-week trial in 507 patients with PD experiencing motor fluctuations.1,2
*Good "On" time is defined as "On" time without troublesome dyskinesia (based on the 2-day average of the self-completed Hauser diary).1,2
Post hoc analysis (TEMPO-3)
Mean change in “On” time with no dyskinesia3
LS mean change from baseline to week 26
Data Limitations: Data are from a post hoc analysis and are not adjusted for multiplicity; no conclusions of statistical significance can be drawn due to the exploratory nature of the analysis.
Long-term OLE (TEMPO-4)
Proportion of patients who did not increase their oral levodopa dose after 85 weeks4
of patients taking JUVMO + oral levodopa did not increase their oral levodopa dose after 85 weeks (n=96/103)
TEMPO-4: Phase 3, open-label, 58-week trial of patients with PD who completed TEMPO-3.5
OLE Limitations: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect; data are descriptive in nature, and findings should be interpreted with caution.
These data represent patients who rolled over from TEMPO-3. Patients were on a fixed dose of oral levodopa for the first 27 weeks in TEMPO-3.
TEMPO-3 & TEMPO-4 (with oral levodopa)
Durable good "On" time* through 85 weeks on JUVMO + oral levodopa1,2,4
Pinch to zoom
In the RCT, analyses used the mITT population: randomized subjects with ≥1 dose of study drug and both baseline and postbaseline assessments. In the OLE, analyses used the FAS population: subjects with ≥1 dose of study drug.1,4,6
TEMPO-4: Phase 3, open-label, 58-week trial of patients with PD who completed TEMPO-3.5
OLE Limitations: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect; data are descriptive in nature, and findings should be interpreted with caution.
*Good "On" time is defined as "On" time without troublesome dyskinesia (based on the 2-day average of the self-completed Hauser diary).1,2
AI-generated depiction. Not a real patient.
Find out how to get your patients started on JUVMO today
Post hoc analysis (TEMPO-3 & TEMPO-4)
Continuous hours of good “On” time* per day3
Pinch to zoom
Continuous good “On” time for placebo + oral levodopa at baseline and week 26 were 4.7 hours and 6.8 hours, respectively.3
Data Limitations: Data are from a post hoc analysis and are not adjusted for multiplicity; no conclusions of statistical significance can be drawn due to the exploratory nature of the analysis.
OLE Limitations: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect; data are descriptive in nature, and findings should be interpreted with caution.
*Continuous “On” time defined as the longest stretch of time during the 16-hour waking day during which patients experienced “On” time without troublesome dyskinesia (good).3
TEMPO-4 (with oral levodopa)
Proportion of patients who did not increase their oral levodopa dose after 85 weeks4
In an open-label extension study, an observed
93%
of patients taking JUVMO + oral levodopa did not increase their oral levodopa dose after 85 weeks (n=96/103)
These data represent patients rolled over from TEMPO-3. Patients were on a fixed dose of oral levodopa for the first 27 weeks in TEMPO-3.
TEMPO-4: Phase 3, open-label, 58-week trial of patients with PD including those who completed TEMPO-3.5
OLE Limitations: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect; data are descriptive in nature, and findings should be interpreted with caution.
FAS=full analysis set; LD=levodopa; LS=least squares; mITT=modified intent-to-treat; OLE=open-label extension; PD=Parkinson’s disease; RCT=randomized controlled trial.
