Studying Patterns in Patient Engagement Among Tardive Dyskinesia Patients

NCT06218719 | Not Yet Recruiting

• 1 other identifier: 57697757
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tardive Dyskinesia

Keywords

tardive dyskinesia

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a tardive dyskinesia clinical research.

  3 months

• Number of tardive dyskinesia study participants who remain in clinical study until completion.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tardive dyskinesia patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• 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.

  PMID: 36114799 BACKGROUND

• 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.

  PMID: 28320223 BACKGROUND

• 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.

  PMID: 33588795 BACKGROUND

MeSH Terms

Conditions

Tardive Dyskinesia

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

US (1)