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

Primary Purpose

Rheumatoid Arthritis, Diabetic Neuropathy, Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DiNaMo Study App

Placebo App

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Smartphone, RA, diabetic neuropathy, fibromyalgia, IBS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Click Therapeutics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DiNaMo Study App

Digital Control App

Arm Description

Randomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

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).

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).

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).

Full Information

NCT ID

NCT05573685

First Posted

October 6, 2022

Last Updated

April 25, 2023

Sponsor

Click Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05573685

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

October 10, 2022 (Actual)

Primary Completion Date

February 6, 2023 (Actual)

Study Completion Date

February 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Click Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Diabetic Neuropathy, Fibromyalgia, Irritable Bowel Syndrome

Keywords

Smartphone, RA, diabetic neuropathy, fibromyalgia, IBS

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Single blind, randomized into 3:1 ratio (3 DiNaMo Study Apps of 4 indications: 1 Digital Control App)

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DiNaMo Study App

Arm Type

Active Comparator

Arm Description

Randomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App

Arm Title

Digital Control App

Arm Type

Placebo Comparator

Arm Description

Randomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App

Intervention Type

Device

Intervention Name(s)

DiNaMo Study App

Intervention Description

Study App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy

Intervention Type

Device

Intervention Name(s)

Placebo App

Intervention Description

Placebo App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy

Primary Outcome Measure Information:

Title

To estimate the effect size for changes in pain experience (interference) in the Treatment App group compared to the Digital Control App group

Description

Effect size change as measured by the Numerical Rating Scale (NRS) questionnaire, from the lowest (0) to the highest (10)

Time Frame

Change from Baseline to Week 4

Secondary Outcome Measure Information:

Title

To explore the feasibility of remote digital DiNaMo training Study App in participants with chronic pain

Description

Time Frame

User experience questionnaire of feasibility recorded on baseline and Week 4

Title

To estimate the effect size for changes in attention to pain in the Treatment App group compared to the Digital Control App group

Description

Change is measured by the Pain Vigilance and Awareness Questionnaire (PVAQ), from the lowest (0) to the highest (5).

Time Frame

Change from baseline to Week 4

Title

To estimate the effect size for changes in pain catastrophizing in the Treatment App group compared to the Digital Control App group

Description

Change is measured by the Pain Catastrophizing Scale (PCS) from the lowest (0) to the highest (4).

Time Frame

Change from baseline to Week 4

Title

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

Description

Change is measured by the Pain Self-efficacy Questionnaire (PSEQ) from the lowest (0) to the highest (6).

Time Frame

Change from baseline to Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaheen Lakhan, MD, PhD, FAAN

Organizational Affiliation

Click Therapeutics, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Click Therapeutics

City

New York

State/Province

New York

ZIP/Postal Code

10013

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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