NCT05573685

Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training

A Randomized, Controlled, Single-Blind, Exploratory Basket Study to Evaluate the Effects of a DiNaMo™ Component Training in Adults With Chronic Pain-Related Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Click Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a multimodal treatment in supplementary or standalone prescription or nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click Therapeutics, Inc. (Click).

Detailed description

The Study App (CT-100-002) contains a class of Digital Neuro-activation and Modulation (DiNaMo™) mechanisms of action that are part of the Click Neurobehavioral Intervention (CNI) Platform™. DiNaMo™ provide interactive, software based therapeutic components that may be included in a multimodal treatment for developing future digital therapeutics. Chronic pain is a transdiagnostic condition which manifests in patients with diverse underlying pathologies such as rheumatoid arthritis, diabetic neuropathy, fibromyalgia, and irritable bowel syndrome. This basket study aims to evaluate the efficacy, safety, and tolerability of CT-100-002 on measures of pain, pain-related functioning, and mood across multiple indications. The study results will further future clinical development of digital therapeutics comprising DiNaMo™ mechanisms of action.

Conditions

• Rheumatoid Arthritis
• Diabetic Neuropathy
• Fibromyalgia
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	DiNaMo Study App	Study App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy
DEVICE	Placebo App	Placebo App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy

Timeline

• Start date: 2022-10-10
• Primary completion: 2023-02-06
• Completion: 2023-02-06
• First posted: 2022-10-10
• Last updated: 2023-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study