Table 2.
Summary of ongoing phase 3 trials of tavapadon for the treatment of Parkinson’s disease.
| Trial Identifier | Study Design | Key Eligibility Criteria | Outcome Measures | Estimated Completiona |
|---|---|---|---|---|
| TEMPO-1 (NCT04201093) [83] | • Phase 3, double-blind, parallel-group RCT in patients with early PD • 27 weeks of treatment with tavapadon (5 or 15 mg QD) or a placebo |
• Diagnosis of PD for <3 years • Modified Hoehn and Yahr stage 1, 1.5, or 2 • Excludes patients with a history of essential tremors, atypical or secondary parkinsonian syndrome, impulse control disorder, hallucinations, or significant neurological disorder • Excludes patients with a history of nonresponse or insufficient response to levodopa |
• Primary: Change from baseline in MDS-UPDRS Parts II and III combined score • Secondary: PGI-C, MDS-UPDRS Parts I, II, and III combined and individual scores, CGI-S, CGI-I, ESS, QUIP-RS, C-SSRS, TEAEs |
• Primary completion: September 2023 • Study completion: October 2023 |
| TEMPO-2 (NCT04223193) [84] | • Phase 3, double-blind, parallel-group, flexible-dose RCT in patients with early PD • 27 weeks of treatment with tavapadon (titrated to 15 mg QD) or a placebo |
• Diagnosis of PD for <3 years • Modified Hoehn and Yahr stage 1, 1.5, or 2 • Excludes patients with a history of essential tremors, atypical or secondary parkinsonian syndrome, impulse control disorder, hallucinations, or significant neurological disorder • Excludes patients with a history of nonresponse or insufficient response to levodopa |
• Primary: Change from baseline in MDS-UPDRS Parts II and III combined score • Secondary: PGI-C, MDS-UPDRS Parts I, II, and III combined and individual scores, CGI-S, CGI-I, ESS, QUIP-RS, C-SSRS, TEAEs |
• Primary completion: July 2023 • Study Completion: August 2023 |
| TEMPO-3 (NCT04542499) [85] | • Phase 3, double-blind, parallel-group, flexible-dose RCT in levodopa-treated adults with motor fluctuations • 27 weeks of treatment with tavapadon (titrated to 15 mg QD) or a placebo |
• Diagnosis of PD • Modified Hoehn & Yahr stage 2, 2.5, or 3 in the “ON” state • Good response to levodopa and stable dose of at least 400 mg for 4 weeks prior to screening • At least 2.5 hours of daily “OFF” time • Excludes patients with a history of essential tremors, atypical or secondary parkinsonian syndrome, impulse control disorder, hallucinations, or significant neurological disorder • Excludes patients with a history of nonresponse or insufficient response to levodopa |
• Primary: Change from baseline in total “ON” time without troublesome dyskinesia at 27 weeks • Secondary: Change from baseline in total “OFF” time at 27 weeks and other time points, change from baseline in total “ON” time without troublesome dyskinesia at other time points, change from baseline in MDS-UPDRS Parts I, II, and III individual scores |
• Primary completion: February 2023 • Study completion: March 2023 |
| TEMPO-4 (NCT04760769) [86] | • Phase 3, open-label extension trial • 58 weeks of treatment with tavapadon (5-15 mg QD) |
• Prior enrollment in and completion of another TEMPO trial OR • Diagnosis of PD, modified Hoehn and Yahr stage 1, 1.5, 2, 2.5 or 3 • Currently treated with levodopa/ carbidopa • Excludes patients with a history of essential tremor, atypical or secondary parkinsonian syndrome, impulse control disorder, hallucinations, or significant neurological disorder • Excludes patients with a history of nonresponse or insufficient response to levodopa |
• TEAEs, treatment discontinuation • QUIP-RS, ESS, C-SSRS, SMWQ • Change from baseline in MDS-UPDRS parts I, II, and III, Hauser diary, EQ-5D-5L index, and visual analog scores |
• Primary completion: November 2024 • Study completion: December 2024 |
aPer ClinicalTrials.gov as of July 2022.
Abbreviations: CGI-I, Clinical Global Impression-Improvement; CGI-S, Clinical Global Impression-Severity; C-SSRS, Columbia-Suicide Severity Rating Scale; ESS, Epworth Sleepiness Scale; EQ-5D-5L, EuroQol 5 Dimension 5 Level; MDS-UPDRS, Movement Disorder Society - Unified Parkinson’s Disease Rating Scale; PD, Parkinson’s disease; PGI-C, Patient Global Impression-Change; QUIP-RS, Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease-Rating Scale; RCT, randomized controlled trial; SMWQ, Study Medication Withdrawal Questionnaire; TEAE, treatment-emergent adverse event.