Rheumatoid ArthritisNCT05573685
Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training
A study testing DiNaMo Study App in people with Rheumatoid Arthritis and Diabetic Neuropathy, run by Click Therapeutics, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis, Diabetic Neuropathy, Fibromyalgia
- What is being tested?
- DiNaMo Study App
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 6 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- DiNaMo Study App, Placebo App
- Keywords
- Smartphone, RA, diabetic neuropathy, fibromyalgia, IBS
- Medical subject headings
- Arthritis, Rheumatoid, Diabetic Neuropathies, Fibromyalgia, Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiNaMo Study AppDevice
Study App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy
Placebo AppDevice
Placebo App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy
| Study group | Role | What they receive |
|---|---|---|
| DiNaMo Study App | Active comparator | Randomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App Receives: Device: DiNaMo Study App |
| Digital Control App | Placebo comparator | Randomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App Receives: Device: Placebo App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from Baseline to Week 4
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Change from baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start10 Oct 2022
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaheen Lakhan, MD, PhD, FAAN, Principal investigator, Click Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573685
- Sponsor's protocol ID
- CT-100-D-002
- Status last verified
- Apr 2023
- First submitted
- 6 Oct 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05573685
- Acronym / sponsor ID
- CT-100-D-002
- Keywords
- Smartphone, RA, diabetic neuropathy, fibromyalgia, IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DiNaMo Study App | Active comparator | Device: DiNaMo Study AppRandomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App |
| Digital Control App | Placebo comparator | Device: Placebo AppRandomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiNaMo Study AppStudy App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy | Device | DiNaMo Study App |
| Placebo AppPlacebo App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy | Device | Digital Control App |
Primary outcome
To estimate the effect size for changes in pain experience (interference) in the Treatment App group compared to the Digital Control App group
Time frame: Change from Baseline to Week 4
Effect size change as measured by the Numerical Rating Scale (NRS) questionnaire, from the lowest (0) to the highest (10)
4 secondary outcomes
To explore the feasibility of remote digital DiNaMo training Study App in participants with chronic pain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaheen Lakhan, MD, PhD, FAAN principal investigator
Click Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiNaMo Study App in people with Rheumatoid Arthritis and Diabetic Neuropathy, run by Click Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the effect size for changes in pain experience (interference) in the Treatment App group compared to the Digital Control App group (time frame: Change from Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.