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Trial record 1 of 4 for:    Intracellular Therapies | Parkinson's
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03257046
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: ITI-214 Other: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 28, 2017
Actual Primary Completion Date : September 6, 2018
Actual Study Completion Date : September 28, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Experimental: 30 mg ITI-214
Administered once daily for 7 days
 Drug: ITI-214
Oral
Experimental: 90 mg ITI-214
Administered once daily for 7 days
 Drug: ITI-214
Oral
Placebo Comparator: Placebo
Administered once daily for 7 days
 Other: Placebo
Oral


Outcome Measures
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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 ]
    Pharmacodynamics


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257046


Locations
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United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
United States, North Carolina
Duke Early Phase Research Unit
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
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Study Director: Kimberly Vanover, PhD Intra-Cellular Therapies, Inc.
More Information
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Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT03257046    
Other Study ID Numbers: ITI-214-105
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases