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

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).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Irritable Bowel Syndrome; Fibromyalgia; Diabetic Neuropathy
• Intervention / Treatment: Device: DiNaMo Study App; Device: Placebo App

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Click Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meets indication-specific eligibility criteria as reported by the study participant with adequate clinical documentation
• Self-reported average pain intensity during the last 7 days of ≥ 3 of 10 on the Numeric rating Scale (NRS scale) associated with the primary indication
• Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form.)
• Willing and able to comply with study protocol and assessments, evidenced by completion of the Screening Survey.
• Lives in the United States.
• Has an active email address and is willing and able to receive email messages.
• Is the sole user of an iPhone with iPhone operating systems (iOS) 14 or later capabilities or a smartphone with an Android operating system (OS) 10 or later capabilities with cellular and/or internet access for the duration of the study period.

Exclusion Criteria:

• Has a comorbid acute pain condition, such as from current injuries
• Participation in a clinical trial (including psychotherapy, mindfulness, cognitive training, or drug treatment) within the last 2 months
• Initiation or change in primary disease-specific medication for 30 days prior to entering the study
• Self-reported substance use disorder within the past 1 year
• Daily use of opioids of 30 MME (Morphine Milligram Equivalents) or more
• Substance use disorder within the past 1 year.
• Initiation or change in central nervous system-active medication (e.g., antidepressants) during the last 2 months.
• Participation in a clinical trial within the last 2 months.
• Planning to introduce new therapies or change therapies during the study duration
• Visual, dexterity or cognitive deficit so severe that precludes the use of an app per investigator judgment.
• Severe psychiatric disorder involving a history of psychosis
• Other significant medical condition that may confound the interpretation of findings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DiNaMo Study App; Randomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App	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
Placebo Comparator: Digital Control App; Randomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate the effect size for changes in pain experience (interference) in the Treatment App group compared to the Digital Control App group	Effect size change as measured by the Numerical Rating Scale (NRS) questionnaire, from the lowest (0) to the highest (10)	Change from Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore the feasibility of remote digital DiNaMo training Study App in participants with chronic pain	Feasibility is measured by using User Experience Questionnaire including engagement and experience with the Study App in participants with chronic pain as measured by metrics such as daily app usage and daily time in the app. The questionnaire will ask questions related to the perceived enjoyment, challenges, and related user experience.	User experience questionnaire of feasibility recorded on baseline and Week 4
To estimate the effect size for changes in attention to pain in the Treatment App group compared to the Digital Control App group	Change is measured by the Pain Vigilance and Awareness Questionnaire (PVAQ), from the lowest (0) to the highest (5).	Change from baseline to Week 4
To estimate the effect size for changes in pain catastrophizing in the Treatment App group compared to the Digital Control App group	Change is measured by the Pain Catastrophizing Scale (PCS) from the lowest (0) to the highest (4).	Change from baseline to Week 4
To estimate the effect size for changes in confidence in dealing with chronic pain in the Treatment App group compared to the Digital Control App group	Change is measured by the Pain Self-efficacy Questionnaire (PSEQ) from the lowest (0) to the highest (6).	Change from baseline to Week 4

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.
• Investigators: Principal Investigator: Shaheen Lakhan, MD, PhD, FAAN, Click Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): February 6, 2023

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Smartphone, RA, diabetic neuropathy, fibromyalgia, IBS
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Endocrine System Diseases; Gastrointestinal Diseases; Diabetes Complications; Diabetes Mellitus; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Diabetic Neuropathies
• Other Study ID Numbers: CT-100-D-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No