Parkinson's disease
Conditions
Brief summary
To Evaluate the safety and tolerability of long-term administration of tavapadon in subjects with PD: •Nature, frequency, and temporality of TEAEs (nonserious and serious), including abuse related AEs and AEs related to MHIs •Frequency of discontinuations •QUIP RS •ESS •C-SSRS •SMWQ •Clinical laboratory evaluations •Vital signs •Physical and neurological examinations •ECGs
Detailed description
To Evaluate the effects of tavapadon on PD symptoms during long-term treatment • Change from baseline in the MDS-UPDRS Parts I, II, and III scores • Change from baseline in the Hauser diary (only in subjects who require daily L-Dopa or equivalent therapy for symptom control at the time of enrollment) • Change from baseline in the EQ-5D-5L index and VAS scores, To evaluate the effects of tavapadon on L-Dopa usage: •Change from baseline in L-Dopa usage, To Evaluate speech and facial expression characteristics of subjects with PD: •Exploratory analyses of audio and video data collected from subject administered remote digital testing of speech and facial expressions through an interactive application platform on the subject's personal mobile device may be conducted
Interventions
DRUGTavapadon
Sponsors
Cerevel Therapeutics LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Evaluate the safety and tolerability of long-term administration of tavapadon in subjects with PD: •Nature, frequency, and temporality of TEAEs (nonserious and serious), including abuse related AEs and AEs related to MHIs •Frequency of discontinuations •QUIP RS •ESS •C-SSRS •SMWQ •Clinical laboratory evaluations •Vital signs •Physical and neurological examinations •ECGs | — |
Secondary
| Measure | Time frame |
|---|---|
| To Evaluate the effects of tavapadon on PD symptoms during long-term treatment • Change from baseline in the MDS-UPDRS Parts I, II, and III scores • Change from baseline in the Hauser diary (only in subjects who require daily L-Dopa or equivalent therapy for symptom control at the time of enrollment) • Change from baseline in the EQ-5D-5L index and VAS scores, To evaluate the effects of tavapadon on L-Dopa usage: •Change from baseline in L-Dopa usage, To Evaluate speech and facial expression characteristics of subjects with PD: •Exploratory analyses of audio and video data collected from subject administered remote digital testing of speech and facial expressions through an interactive application platform on the subject's personal mobile device may be conducted | — |
Countries
Bulgaria, Czechia, France, Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed