A Phase 1/2 interventional study of ITI-214 and Placebo in Parkinson Disease, sponsored by Intra-Cellular Therapies, Inc.. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-12-20.
Sponsored by Intra-Cellular Therapies, Inc. (part of Johnson & Johnson) · Phase 1/2, Interventional, and Treatment
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Among 1,649 studies in Parkinson Disease with a site in United States — 304 open to participants now, 387 under way, 7 of them phase 3. Parkinson Disease · United States.
Among the 1,649 studies in Parkinson Disease with a site in United States, this one is the 554th largest by enrollment of the 1,256 interventional ones that give a count, is one of 85 that started in 2017, is one of 51 in phase 1/2, and was the 805th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →304 of the 1,649 studies in Parkinson Disease with a site in United States are open now. Recruiting first, the newest first:
The Cleveland Clinic · Sites in United States
Ages 18+
University of Colorado, Denver · Sites in United States
Ages 45–75
University of Minnesota · Sites in United States
Ages 18+
Hoffmann-La Roche · Sites in United States, China, United Kingdom
Ages 40–85
Medical University of South Carolina · Sites in United States
Ages 50–85
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 750 Parkinson Disease studies recruiting now, 312 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 190 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,649 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 226 · Phase 2 304 · Phase 3 145 · Phase 4 75
First in 1991; this study’s year is marked. 85 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is close to the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 36 across the 1,256 interventional studies, 78 across the 379 observational. Of the 1,139 that completed or were terminated, 435 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
470 of 1,649 have an industry lead sponsor. The 10 most frequent:
This study is registered under Intra-Cellular Therapies, Inc., one of the names counted as Johnson & Johnson. Under that name alone:
Intra-Cellular Therapies, Inc. is the lead sponsor of 41 studies on the registry; 12 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
Johnson & Johnson has 2 studies filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
137 of the studies in Parkinson Disease with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06976268Phase 3Biohaven Therapeutics Ltd.A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease | 2027-08 |
| NCT06098612Massachusetts General HospitalPET Imaging Evaluation of [11C]SY08 | 2026-11 |
| NCT06489483University of Texas Southwestern Medical CenterAction Regulation Behavioral | 2026-11 |
| NCT05558189Stanford UniversityVibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients | 2026-11-21 |
| NCT06773962TrueBinding, Inc.A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease | 2026-11-28 |
Add all 137 to your calendar (.ics) → With an account.
Among the 1,649 studies in Parkinson Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Major Inclusion Criteria:
Major Exclusion Criteria:
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Other: Placebo
Oral
Oral
Number of patients with reported or observed treatment-related adverse events
Safety and tolerability
Time frame: 7 days
Maximum Plasma Concentration (Cmax)
Pharmacokinetics
Time frame: 7 days
Area of the Curve (AUC)
Pharmacokinetics
Time frame: 7 days
Motor and non-motor symptoms as assessed by the MDS-UPDRS
Pharmacodynamics
Time frame: 7 days
Exploratory biomarkers
Pharmacodynamics
Time frame: 7 days
Ran from Sep 2017 to primary completion in Sep 2018, 11 months.
Of 55 phase 1/2 interventional studies under Parkinson Disease, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ITI-214
Intra-Cellular Therapies, Inc. →