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DiNaMo Study App for Fibromyalgia

N/A

Waitlist Available

Led By Shaheen Lakhan, MDPhD, FAAN

Research Sponsored by Click Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to week 4

Awards & highlights

Study 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).

Eligible Conditions

Fibromyalgia
Diabetic Neuropathy
Rheumatoid Arthritis
Irritable Bowel Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

Secondary outcome measures

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

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

Pain

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DiNaMo Study AppActive Control1 Intervention

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

Group II: Digital Control AppPlacebo Group1 Intervention

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

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Who is running the clinical trial?

Click Therapeutics, Inc.Lead Sponsor

15 Previous Clinical Trials

2,843 Total Patients Enrolled

Shaheen Lakhan, MDPhD, FAANPrincipal InvestigatorClick Therapeutics

4 Previous Clinical Trials

212 Total Patients Enrolled

Shaheen Lakhan, MD, PhD, FAANPrincipal InvestigatorClick Therapeutics, Inc.

2 Previous Clinical Trials

648 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you approximate the aggregate of participants in this trial?

"Affirmative. According to the information found on clinicaltrials.gov, this trial is actively looking for participants and was initially posted October 10th 2022. The study seeks 120 individuals at 2 medical centres."

Answered by AI

Does this experimental procedure accept individuals aged 45 and older?

"The cut-off for enrolment in this trial is 18 years old and the upper age limit has been set at 65."

Answered by AI

Is there an opportunity to join this research endeavor?

"This investigation is searching for 120 individuals aged 18 to 65 suffering from rheumatoid arthritis. To qualify, patients must have fluency in English (as certified by the comprehension of Informed Consent Forms), possess an active email address and be willing to receive messages, own a phone with either iOS 14 or higher or Android OS 10 or above that can access cellular/internet connection throughout the study duration, comply with indication-specific criteria corroborated through clinical history, exhibit moderate pain intensity as reported on NRS scale over 7 days prior to screening survey completion, agree to follow all protocol requirements and reside in the United States."

Answered by AI

Are applications still being accepted for participation in this research?

"Affirmative. The information published on clinicaltrials.gov confirms that this research endeavour, initially posted on October 10th 2022, is actively recruiting volunteers. Approximately 120 participants are required from two different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05573685.