Impact on Tremor in Phase Three Trials of Tavapadon: A Selective D1/D5 Agonist for Treatment of Parkinson’s Disease
Diego Torres-Russotto1, Linda Harmer2, Tracy Nicholson2, Perminder Bhatia3
1Baptist Health South Florida Miami Neuroscience Institute, 2AbbVie, Inc., 3Neuro Pain Medical Center
Objective:
Evaluate the effect of tavapadon on tremor, as assessed by items on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).
Background:
TEMPO-1 (NCT04201093) and TEMPO-2 (NCT04223193) trials demonstrated efficacy and acceptable safety of tavapadon in people with early Parkinson’s disease (PD). Tremor is one of the most bothersome symptoms in early PD. The effects of tavapadon on tremor in early PD have not been evaluated.
Design/Methods:
Participants with early PD (duration <3 years) were randomized to 27-week treatment with tavapadon (TEMPO-1: fixed dose of 5 or 15 mg once daily; TEMPO-2: flexible dose of 5-15 mg once daily) or placebo. This post hoc analysis evaluated the effects of tavapadon on tremor, as measured by MDS-UPDRS Part II Item 10 (patient experiences of tremor) and Part III Items 15A-18 (clinician-assessed postural tremor, kinetic tremor, rest tremor amplitude, and rest tremor consistency).
Results:
Treatment with tavapadon provided significant improvements in patient experiences of tremor (Part II) relative to placebo. In TEMPO-2 (N=304), tavapadon improved tremor scores by 32% at Week 26 versus 6% with placebo (least squares mean [LSM] change from baseline: placebo, 0.0; 5-15 mg tavapadon, −0.4; LSM difference from placebo [95% CI], −0.3 [−0.5, −0.2]; P<0.0001). Of TEMPO-2 participants who experienced baseline impairment due to tremor (ie, score ≥1), ≥1-point improvements at Week 26 were reported in 45.2% of the tavapadon group and 23.3% of the placebo group, with symptom resolution (ie, score of 0) in 26.2% and 7.5% of tavapadon and placebo-treated participants, respectively. Similar trends were observed in TEMPO-1 (N=529). Most clinician-assessed tremor items (Part III) were significantly improved relative to placebo (TEMPO-1: 5/10 items; TEMPO-2: 7/10 items); items that did not reach significance generally had low baseline scores (ie, median score of 0 or 1).
Conclusions:
People with early PD treated with tavapadon experienced improvements across multiple tremor-related assessments.
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