Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
Status and phase
Completed
Phase 2
Phase 1
Conditions
Parkinson Disease
Treatments
Drug: ITI-214
Other: Placebo
Details and patient eligibility
About
This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ITI-214.
Enrollment
40 patients
Sex
All
Ages
50+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Major Inclusion Criteria:
- Clinical diagnosis of idiopathic Parkinson's disease (PD)
- Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3
- Maintenance on stable PD therapy
Major Exclusion Criteria:
- Clinical signs of dementia
- Suicidal ideation or behavior
- Considered medically inappropriate for study participation
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
40 participants in 6 patient groups, including a placebo group
1 mg ITI-214
Experimental group
Description:
Administered once daily for 7 days
Treatment:
Drug: ITI-214
3 mg ITI-214
Experimental group
Description:
Administered once daily for 7 days
Treatment:
Drug: ITI-214
10 mg ITI-214
Experimental group
Description:
Administered once daily for 7 days
Treatment:
Drug: ITI-214
30 mg ITI-214
Experimental group
Description:
Administered once daily for 7 days
Treatment:
Drug: ITI-214
90 mg ITI-214
Experimental group
Description:
Administered once daily for 7 days
Treatment:
Drug: ITI-214
Placebo
Placebo Comparator group
Description:
Administered once daily for 7 days
Treatment:
Other: Placebo
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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