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History of Changes for Study: NCT03257046
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
Latest version (submitted December 18, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 17, 2017 None (earliest Version on record)
2 September 26, 2017 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Oversight
3 October 3, 2017 Study Status
4 April 26, 2018 Arms and Interventions, Study Design and Study Status
5 July 25, 2018 Study Status, Arms and Interventions and Study Design
6 December 18, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT03257046
Submitted Date:  August 17, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: ITI-214-105
Brief Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
Official Title: A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2017
Overall Status: Not yet recruiting
Study Start: October 2017
Primary Completion: May 2018 [Anticipated]
Study Completion: August 2018 [Anticipated]
First Submitted: August 14, 2017
First Submitted that
Met QC Criteria:
August 17, 2017
First Posted: August 22, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
August 17, 2017
Last Update Posted: August 22, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Intra-Cellular Therapies, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Parkinson Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 24 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral
Experimental: 3 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral
Experimental: 10 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral
Placebo Comparator: Placebo
Administered once daily for 7 days
Placebo
Oral
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of patients with reported or observed treatment-related adverse events
[ Time Frame: 7 days ]

Safety and tolerability
Secondary Outcome Measures:
1. Maximum Plasma Concentration (Cmax)
[ Time Frame: 7 days ]

Pharmacokinetics
2. Area of the Curve (AUC)
[ Time Frame: 7 days ]

Pharmacokinetics
3. Motor and non-motor symptoms as assessed by the MDS-UPDRS
[ Time Frame: 7 days ]

Pharmacodynamics
Other Outcome Measures:
1. Exploratory biomarkers
[ Time Frame: 7 days ]

Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Kimberly Vanover, PhD
Telephone: 646-440-9333
Email: itciclinicaltrials@intracellulartherapies.com
Study Officials: Kimberly Vanover, PhD
Study Director
Intra-Cellular Therapies, Inc.
Locations: United States, North Carolina
Duke Early Phase Research Unit
Durham, North Carolina, United States, 27708
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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