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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatoid Arthritis, Diabetic Neuropathy, Fibromyalgia, Irritable Bowel Syndrome

Intervention / Treatment
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* Device: DiNaMo Study App
* Device: Placebo App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DiNaMo Study App<br>Randomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App | Device: DiNaMo Study App<br>* Study App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy<br>|
| Placebo Comparator: Digital Control App<br>Randomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App | Device: Placebo App<br>* Placebo App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartphone, RA, diabetic neuropathy, fibromyalgia, IBS