Parkinson DiseasePhase 1/2NCT03257046
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
A Phase 1/2 study testing ITI-214 in people with Parkinson Disease, run by Intra-Cellular Therapies, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ITI-214
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2017to 28 Sep 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Duke Early Phase Research Unit
Durham, North Carolina, 27708
About this study
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
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.
- Conditions
- Parkinson Disease
- Being tested
- ITI-214, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-214Drug
Oral
PlaceboOther
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 mg ITI-214 | Experimental | Administered once daily for 7 days Receives: Drug: ITI-214 |
| 3 mg ITI-214 | Experimental | Administered once daily for 7 days Receives: Drug: ITI-214 |
| 10 mg ITI-214 | Experimental | Administered once daily for 7 days Receives: Drug: ITI-214 |
| 30 mg ITI-214 | Experimental | Administered once daily for 7 days Receives: Drug: ITI-214 |
| 90 mg ITI-214 | Experimental | Administered once daily for 7 days Receives: Drug: ITI-214 |
| Placebo | Placebo comparator | Administered once daily for 7 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with reported or observed treatment-related adverse events
Safety and tolerability
Measured: 7 days
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax)
Pharmacokinetics
Measured: 7 days
Area of the Curve (AUC)
Pharmacokinetics
Measured: 7 days
Motor and non-motor symptoms as assessed by the MDS-UPDRS
Pharmacodynamics
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start28 Sep 2017
- Primary completion6 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly Vanover, PhD, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257046
- Sponsor's protocol ID
- ITI-214-105
- Status last verified
- Dec 2018
- First submitted
- 14 Aug 2017
- Last updated
- 20 Dec 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03257046
- Acronym / sponsor ID
- ITI-214-105
- Conditions
- Parkinson Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo
| Arm | Type | Receives |
|---|---|---|
| 1 mg ITI-214 | Experimental | Drug: ITI-214Administered once daily for 7 days |
| 3 mg ITI-214 | Experimental | Drug: ITI-214Administered once daily for 7 days |
| 10 mg ITI-214 | Experimental | Drug: ITI-214Administered once daily for 7 days |
| 30 mg ITI-214 | Experimental | Drug: ITI-214Administered once daily for 7 days |
| 90 mg ITI-214 | Experimental | Drug: ITI-214Administered once daily for 7 days |
| Placebo | Placebo comparator | Other: PlaceboAdministered once daily for 7 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITI-214Oral | Drug | 1 mg ITI-214, 10 mg ITI-214, 3 mg ITI-214, 30 mg ITI-214, 90 mg ITI-214 |
| PlaceboOral | Other | Placebo |
Primary outcome
Number of patients with reported or observed treatment-related adverse events
Time frame: 7 days
Safety and tolerability
3 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: 7 days
Area of the Curve (AUC)
Time frame: 7 days
Motor and non-motor symptoms as assessed by the MDS-UPDRS
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Vanover, PhD study director
Intra-Cellular Therapies, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ITI-214 in people with Parkinson Disease, run by Intra-Cellular Therapies, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with reported or observed treatment-related adverse events (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.