Clinical trial NCT05573685: Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training
Official title: A Randomized, Controlled, Single-Blind, Exploratory Basket Study to Evaluate the Effects of a DiNaMo™ Component Training in Adults With Chronic Pain-Related Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Diabetic Neuropathy
Fibromyalgia
Irritable Bowel Syndrome
Keywords: Smartphone, RA, diabetic neuropathy, fibromyalgia, IBS
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: To estimate the effect size for changes in pain experience (interference) in the Treatment App group compared to the Digital Control App group
timeFrame: Change from Baseline to Week 4
Secondary outcomes:
measure: To explore the feasibility of remote digital DiNaMo training Study App in participants with chronic pain
timeFrame: User experience questionnaire of feasibility recorded on baseline and Week 4
measure: To estimate the effect size for changes in attention to pain in the Treatment App group compared to the Digital Control App group
timeFrame: Change from baseline to Week 4
measure: To estimate the effect size for changes in pain catastrophizing in the Treatment App group compared to the Digital Control App group
timeFrame: Change from baseline to Week 4
measure: 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
timeFrame: Change from baseline to Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
affiliation: Click Therapeutics, Inc.
name: Shaheen Lakhan, MD, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References: