Clinical Trial Finder

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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05573685
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Click Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Shaheen Lakhan, MD, PhD, FAAN
Principal Investigator Affiliation Click Therapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis, Diabetic Neuropathy, Fibromyalgia, Irritable Bowel Syndrome
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: DiNaMo Study App

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

Placebo Comparator: Digital Control App

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

Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Click Therapeutics, New York, New York

Status

Recruiting

Address

Click Therapeutics

New York, New York, 10013

Site Contact

Shaheen Lakhan, MD, PhD, FAAN

[email protected]

877-352-5425 #2

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