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
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Dyskinesias
• Tardive Dyskinesia

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