- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06218719
Studying Patterns in Patient Engagement Among Tardive Dyskinesia Patients
Examining Engagement Patterns: An Observational Exploration About Tardive Dyskinesia Clinical Trials
The statistical analysis of the collected data aims to reveal the many factors that influence patient involvement in clinical trials. Findings will be disseminated through conferences and scholarly papers to benefit all parties participating in clinical trials.
These findings will help to shape the design of future clinical trials for people with tardive dyskinesia, as well as enhance recruiting techniques and retention rates.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michael B Gill
- Phone Number: 4159004227
- Email: bask@withpower.com
Study Locations
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California
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San Francisco, California, United States, 94107
- Power Life Sciences
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Contact:
- Michael B Gill
- Phone Number: 415-900-4227
- Email: https://www.withpower.com/contact-us@withpower.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of tardive dyskinesia
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- No prior treatment for tardive dyskinesia
Exclusion Criteria:
- Enrolled in another research study
- Inability to provide written informed consent
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients who decide to enroll in a tardive dyskinesia clinical research.
Time Frame: 3 months
|
3 months
|
Number of tardive dyskinesia study participants who remain in clinical study until completion.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Publications and helpful links
General Publications
- Hauser RA, Factor SA, Marder SR, Knesevich MA, Ramirez PM, Jimenez R, Burke J, Liang GS, O'Brien CF. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017 May 1;174(5):476-484. doi: 10.1176/appi.ajp.2017.16091037. Epub 2017 Mar 21.
- Horiguchi J, Watanabe K, Kondo K, Iwatake A, Sakamoto H, Susuta Y, Masui H, Watanabe Y. Efficacy and safety of valbenazine in Japanese patients with tardive dyskinesia: A multicenter, randomized, double-blind, placebo-controlled study (J-KINECT). Psychiatry Clin Neurosci. 2022 Nov;76(11):560-569. doi: 10.1111/pcn.13455. Epub 2022 Sep 17.
- Farrar M, Lundt L, Franey E, Yonan C. Patient perspective of tardive dyskinesia: results from a social media listening study. BMC Psychiatry. 2021 Feb 15;21(1):94. doi: 10.1186/s12888-021-03074-9.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 57697757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Synchroneuron Inc.WithdrawnDrug-induced Tardive DyskinesiaUnited States
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Centre for Addiction and Mental HealthMerck KGaA, Darmstadt, GermanyTerminatedNeuroleptic-induced Tardive DyskinesiaCanada, India
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-
Mitsubishi Tanabe Pharma CorporationCompleted
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-
Shanghai Mental Health CenterUnknownTardive DyskinesiaChina
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Neurocrine BiosciencesEvideraUnknownTardive DyskinesiaUnited States
-
Neurocrine BiosciencesCompletedTardive DyskinesiaUnited States, Puerto Rico