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NCT06218719 Clinical Trial

Studying Patterns in Patient Engagement Among Tardive Dyskinesia Patients

Tardive Dyskinesia Clinical Trial

Official title:
Examining Engagement Patterns: An Observational Exploration About Tardive Dyskinesia Clinical Trials

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06218719
Other study ID # 57697757
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2025
Est. completion date February 2027

Study information
Verified date January 2024
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 4159004227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date February 2027
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of patients who decide to enroll in a tardive dyskinesia clinical research. 3 months
Primary Number of tardive dyskinesia study participants who remain in clinical study until completion. 12 months
See also
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Completed NCT01688037 - NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study) Phase 2
Completed NCT01391390 - Melatonin Treatment for Tardive Dyskinesia in Schizophrenia N/A
Withdrawn NCT03254186 - Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia Phase 2/Phase 3
Completed NCT02291861 - Addressing Involuntary Movements in Tardive Dyskinesia Phase 3
Completed NCT02274558 - A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia Phase 3
Completed NCT02198794 - Reducing Involuntary Movements in Participants With Tardive Dyskinesia Phase 3
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Recruiting NCT06011408 - Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes N/A
Recruiting NCT05859698 - Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia Phase 4
Active, not recruiting NCT02252380 - ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders N/A
Terminated NCT00917293 - Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia Phase 2
Completed NCT01543321 - Xenazine in Late Dyskinetic Syndrome With Neuroleptics Phase 3
Completed NCT02405091 - Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia Phase 3
Completed NCT03176771 - Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia Phase 2/Phase 3
Terminated NCT02524886 - Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia N/A
Completed NCT02195700 - Aim to Reduce Movements in Tardive Dyskinesia Phase 2/Phase 3
Completed NCT02736955 - Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia Phase 3
Completed NCT03497013 - Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia N/A