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Digital Therapeutic
Arm A for Migraine (ReMMi-D Trial)
Phase 3
Waitlist Available
Led By Parth Shah
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 baseline to weeks 4, 8 and 12
Awards & highlights
ReMMi-D Trial Summary
This trial tested two digital tools to see if they could stop migraines before they start.
Who is the study for?
This trial is for adults who've had migraines since before age 50, experience them 4-14 days a month, manage with prescription treatments, and have access to a smartphone. Excluded are those using certain painkillers frequently, with chronic pain conditions other than migraine or significant medical issues that could affect results.Check my eligibility
What is being tested?
The study is examining two digital therapeutics designed to prevent episodic migraines. Participants will be randomly assigned to use one of the digital tools and their effectiveness in preventing migraines will be evaluated.See study design
What are the potential side effects?
Since this trial involves digital therapeutics rather than medication, traditional side effects like you might see with drugs aren't expected. However, users may experience discomfort or frustration if they find the technology difficult to use.
ReMMi-D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to weeks 4, 8 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4, 8 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in MMD (monthly migraine days)
Secondary outcome measures
Change in MIDAS
Change in MSQ
Change in average headache severity
+5 moreReMMi-D Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Group II: Arm AExperimental Treatment1 Intervention
Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.
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Who is running the clinical trial?
Click Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
2,409 Total Patients Enrolled
1 Trials studying Migraine
110 Patients Enrolled for Migraine
Parth ShahPrincipal InvestigatorObvioHealth
4 Previous Clinical Trials
420 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of basilar migraine or hemiplegic migraine.You have ongoing chronic pain conditions like fibromyalgia, chronic pelvic pain, or complex regional pain syndrome (CRPS).You started experiencing migraines before turning 50 years old.You have migraine attacks that typically last between 4 and 72 hours if you don't take any treatment for them.You have experienced between 4 and 14 migraine days per month in the last 3 months before the screening visit.You experience between four and fourteen migraine days during the initial period.You are currently taking a prescription medicine for migraine headaches called anti-calcitonin gene-related peptide (CGRP).You have another ongoing medical condition that could make it difficult to understand the results of the study.You have a headache that started after a head injury and it has been lasting for a long time.You have certain types of pain, mental health conditions, or neurological disorders that could affect the study evaluations.You have a history of alcohol or drug abuse in the past year, or you have been diagnosed with a significant substance use disorder in the past year.You have been experiencing migraines for at least a year, as diagnosed by a doctor using specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Migraine Patient Testimony for trial: Trial Name: NCT05853900 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Arm A received regulatory acceptance from the Food and Drug Administration?
"Arm A has been assigned a score of 3, as the Phase 3 trial provides evidence for efficacy and multiple rounds have assessed its safety."
Answered by AI
Are participants still being welcomed for this research endeavor?
"As indicated by clinicaltrials.gov, this medical trial is recruiting participants and the information was recently updated on May 2nd 2023 after its initial publication in March 28th of the same year."
Answered by AI
What is the number of participants undergoing this trial?
"Correct. According to clinicaltrials.gov, the trial - originally posted on March 28th 2023 - is actively looking for potential candidates. The study requires 558 participants from a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
South Carolina
Other
New York
What site did they apply to?
Click Therapeutics
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
1
0
What questions have other patients asked about this trial?
Why did patients apply to this trial?
Been trying everything under the sun for my migraines. I want to help myself and others with their struggles with migraines and headaches.
PatientReceived 1 prior treatment
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