– FokusRxTM feasibility study demonstrates positive results –
– Company plans to initiate Phase 3 trial with FokusRx in ADHD in the second half of 2022 –
WAKE FOREST, N.C., Feb. 02, 2022/PR Distribution™/ -- Revibe technologies, a commercial-stage digital therapeutics company, announced today the positive results of their feasibility study examining the efficacy of FokusRx in school aged children with attention deficit hyperactivity disorder (ADHD). FokusRx is an investigational SaMD (Software as a Medical Device) that has the potential to provide a new nonpharmacologic approach to treating attention, focus and hyperactivity deficits associated with ADHD, and other mental health conditions.
ADHD is one of the most commonly diagnosed and increasingly prevalent mental health disorders in children and adolescents.1,2 In the United States, 6.1 million children aged 2-17 years have been diagnosed with ADHD.3 Approximately 50% of families stop using prescription drug treatments for ADHD within a year.4 Over 30% of parents refuse pharmacologic treatment for their children with ADHD.5,6
In this, single-arm multi-rater feasibility study, parents (n = 38) and teachers (n = 26) rated youth aged 8-12 years with a parent-reported diagnosis of ADHD. Youth were attending in-person classroom learning and not taking medication for their ADHD. The study included a number of outcome measures including the ADHD-RS-5 (Home and School versions), Conners 4 – short version, Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P), and the Academic Performance Rating Scale (APRS). To be included in the analyses, youth had to have worn the Revibe Connect wearable device to school Monday to Friday for a at least three days per week or a minimum of 15 days total for a period of four weeks.
The study found:
• Statistically significant improvement in ADHD symptoms as measured by the ADHD-RS-5 Total Score rated by both parents and teachers (Parents: p < .001, d = 1.01; Teacher: p = .004, r = .57). Clinically significant change on Total score (≥ 30%) was demonstrated for parent ratings, while teacher ratings approached this threshold (28% change).
• Statistically significant improvements in ADHD symptoms (Inattention/Executive Dysfunction, Hyperactivity, Impulsivity, Emotional Dysregulation) and functioning (schoolwork, peer relationships, family relationships) as measured by the Conners 4 and rated by parents ( p ranges from .20 to <.001, d ranges from .39 to 1.21). Similar improvements were reported based on teacher ratings for Inattention/Executive Dysfunction (INA/EDF; p = .005, d = .60), Impulsivity (p = .03, d = .45, and Schoolwork (p = .04, r = .40). Improvements exceeded a 5-point change (0.5 SD) and in the case of INA/EDF and Schoolwork a 10-point change (1.0 SD) based on parent ratings. For teacher ratings a 5-point change was demonstrated for INA/EDF and approached this threshold for Impulsivity and Schoolwork.
• Statistically significant improvements in 4 of 6 domains of functioning (Family, School, Life Skills, and Social Activities) as measured by the WFIRS-P, as well as the Total Score (p < .001, d = .66). Clinically significant change ( ≥ .25) demonstrated for both School Learning and Life Skills.
• Statistically significant improvement in academic performance (Total score) as rated by teachers (p = .007, d = .58).
“We are pleased that the feasibility study has proven to be a successful exercise that de-risks our upcoming randomized sham-controlled pivotal trial. The moderate to large effect sizes observed and change scores that exceed standards for minimally important (clinically significant) differences, provide encouraging preliminary evidence supporting the efficacy of our intervention”, says Dr. Lindsay Ayearst, Chief Scientific Officer of Revibe.
Revibe’s Scientific and Medical Advisory Board member, Dr. Margaret Weiss, Director of Clinical Research in Child Psychiatry at Cambridge Health Alliance, stated, “These results are consistent across both symptoms and functioning, and across informants. They would translate into clinically significant change. Most impressive is the demonstration of an effect on academic performance.”
“The data from the classroom feasibility study suggests FokusRx can effectively and safely improve ADHD symptoms and functioning in school-aged children. It is our intention that FokusRx will provide kids and parents another option to help them succeed and reach their full potential. We are excited to start designing our pivotal trial planned for the fall,” said Joseph Koziak, Chief Executive Officer of Revibe.
About FokusRx
FokusRx is an investigational SaMD designed to provide a new nonpharmacologic approach to treating symptoms and impairment associated with ADHD. The FokusRx software is embedded within a dedicated smart watch to act as a digital therapeutic wearable.
About Revibe Technologies
Revibe Technologies is passionate about leveraging technology to help children and adults with focus and attention problems overcome obstacles in order to succeed in life. Revibe Technologies hopes to be a resource for students, parents, teachers, schools, and clinicians. https://revibetech.com/
References
1- Perou R, Bitsko RH, Blumberg SJ, et al. Mental health surveillance among children – United States, 2005–2011. MMWR Morb Mortal Wkly Rep. 2013;62(2):1-35.
2- Xu G, Strathearn L, Liu B, Yang B, Bao W. Twenty-year trends in diagnosed attention-deficit/hyperactivity disorder among US children and adolescents, 1997-2016. JAMA Netw Open. 2018;1(4):e181471.
3- Danielson ML, Bitsko RH, Ghandour RM, Holbrook JR, Kogan MD, Blumberg SJ. Prevalence of parent-reported ADHD diagnosis and associated treatment among U.S. children and adolescents, 2016. J Clin Child Adolesc Psychol. 2018;47(2):199-212.
4- Winterstein AG, Gerhard T, Shuster J, et al. Utilization of pharmacologic treatment in youths with attention deficit/hyperactivity disorder in Medicaid database. Ann Pharmacother. 2008;42(1):24-31.
5- Demidovich M, Kolko DJ, Bukstein OG, Hart J. Medication refusal in children with oppositional defiant disorder or conduct disorder and comorbid attention-deficit/hyperactivity disorder: medication history and clinical correlates. J Child Adolesc Psychopharmacol. 2011;21(1):57-66.
6- Krain AL, Kendall PC, Power TJ. The role of treatment acceptability in the initiation of treatment for ADHD. J Atten Disord. 2005;9(2):425-434.
FokusRx is an investigational product that is not for sale. Results have not yet been peer-reviewed or published in a journal, and therefore, are considered preliminary. FokusRx has not been cleared by the FDA, nor have these results been validated by the FDA with regard to the safety or efficacy of FokusRx.
