Issue 206
Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O Fridays.
It’s another slow end-of-summer week in FDA-regulated and pharma-focused digital health…
- Read on for a round-up of new digital therapeutic clinical trials along with updates on a few that E&O has been tracking over the years…
Whoa, whoa… Hey there, stranger. Was this paying subscribers-only newsletter forwarded to you? Follow me over to the E&O pricing page for more info on how to sign yourself up.
Trials: Big Health, Akili, Click Therapeutics, Laguna Health, Koa Health, Omada Health, 2Morrow
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues.
New: Big Health’s Rise study tests its digital therapeutic vs waitlist control
Here’s yet another sign that Big Health may be submitting its digital therapeutic to the FDA with a depression treatment claim — a new study, called Rise. What’s curious to me is that this study makes no mention of Sleepio (even though the name of the study “Rise” has echoes of it.) Is this a brand new digital therapeutic focused entirely on depression? More details:
“This study aims to examine the effectiveness of app-based digital CBT in individuals with a diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.”
New: Click Therapeutics study on digital therapeutics focused on patients taking CGRPs for episodic migraine
Here’s an interesting new trial from Click that is focused on a digital therapeutic for people with episodic migraine who are taking a particular type of pharmaceutical treatment. The digital therapeutic aims to prevent migraines. More:
“The purpose of this randomized trial is to evaluate the efficacy and safety of two prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adolescents and adults who are receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.”
New: 2Morrow Chronic Pain Management trial
2Morrow is probably best known for its smoking cessation programs, so this is a new one. The University of Washington is sponsoring a study of 2Morrow’s Chronic Pain Management app. More:
“The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.”
New: Akili set up a patient registry for EndeavorRx
Akili is the latest digital health company to set up a patient registry. The company is calling this clinical trial “Expedition EndeavorRx”. Here’s more:
“The objectives of this registry are to describe clinical and demographic characteristics, prescribing patterns, treatment patterns, and outcomes in participants treated with EndeavorRx in a real-world setting. Patients and their caregivers will be informed about the registry as part of a series of product welcome emails following product activation. Patients/caregivers enroll into the study by providing their electronic informed consent (eConsent) and assent (eAssent). All data are captured electronically and securely through a commercial data capture platform. Participants can also invite their child’s teacher to submit surveys of their observations of the child’s ADHD symptoms for the study. Study activities are emailed to caregivers at baseline, 1, 2, 3, and 6-months after enrollment. A valid and active EndeavorRx prescription is required to enroll. However, an active prescription throughout the entire 6 months of study participation is not required.”
New: Laguna Health is working with MGH to pilot its new behavioral health program
Laguna just raised its Series A in May so it may be a new name for you. Here’s the study it is running in partnership with Mass General:
“The overall goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of using a behavioral coaching intervention (Laguna Health) for optimizing post-hospital discharge care in patients with cancer. Patients will be randomly assigned into one of the study groups: the behavioral coaching intervention (Laguna Health) + usual care versus usual care alone. The Laguna Health intervention has several components:
- Post-Discharge Recovery Coaching with a Laguna Health recovery coach to help patients identify barriers to post-discharge recovery
- Digital psycho-educational content tailored to the needs of patients with cancer
- Personal healthcare summaries
- Digital content and coaching on behavioral strategies to promote self-efficacy”
Links to E&O’s reports, databases, newsletters
The Exits & Outcomes site is designed to make it easy to find long-form research reports, databases, and past newsletter editions. Click below for dedicated pages for each of those categories:
- Read through the long-form E&O research reports here.
- Search and sort the E&O databases here.
- Skim more than 300 past issues of E&O newsletters here.
