PhenoSolve LLC — Department of Health and Human Services SBIR Phase I: NICHD

Description

We have described an autosomal dominant syndrome that we callSensory Overstimulation SyndromeSOSThe most distinctive feature is the relative ineffectiveness of the local anesthetic lidocainea drug that blocks sodium channelsTheother key findingsbased on characterization ofpatientsare inattentionpainful muscle crampsand in femalessevere Premenstrual SyndromePMSWe estimate that SOS affectsof the entire populationormillion people in the USAwhich would make this syndrome among the most frequent causes of each of these diverse findingsproviding a genetic diagnosis for many who had previously been given non syndromic diagnoses such as ADHD or PMSWe have developed a biological test kit for the lidocaine ineffectiveness that is simplenon invasivenot painfuland nongameable by people who are normal but trying to obtain drugs of abuseThe diagnostic test kit prototype has been tested in a small studynIt has been protected with a patent filing and the FDA has asked us to validate the test kit in controlled trials before filing for marketing approvalThe importance of this test goes beyond a reaching a correct diagnosis and selecting alternate local anestheticsSOS patients with inattention respond well to potassium treatmentsreducing the need for stimulantsWe expect impact on drug abusepremenstrual syndromeand severe pain due to dental treatment in people with lidocaine ineffectivenessoften dismissed as if it were due todental anxietyWe propose the followingAimAssess reliability of taste based lidocaine test kit in a controlled trial and compare to lidocaine injectionThe ability of lidocaine oral gel to block tastesalt and sucrose solutionswill be assessed inadults and thenteenagershalf each with history of lidocaine ineffectivenessThe painless taste based lidocaine test will be evaluated in a randomized controlled trialtestedtimes on different days for each subject to determine the reproducibilityAt the FDAandapos s requesteach subject will also have thegold standardof injection of lidocaineassessed using painfor comparisonAimUse the test kit to determine the prevalence of lidocaine ineffectiveness in the general populationWe will use the test kit to determine the prevalence of lidocaine ineffectiveness by studyingindividuals ageswith no diagnosis of inattention to characterize the prevalence in the general populationexpect ineffective inAimUse the test kit to determine the prevalence of lidocaine ineffectiveness in patients with ADHDUsing the test kitwe will test the association between lidocaine ineffectiveness and inattention by studyingindividuals ageswith inattentionchosen from those who had been diagnosed with ADHDexpect ineffective inWe expect that this lidocaine test will provide a mechanistic biomarker for identification of the SOS syndrome in significant fractions of people currently diagnosed as having ADHD or PMSGiven the apparent high prevalence of SOSthe potential of the lidocaine taste test kit for commercialization is highas is the impact on public health This research is to validate a test for a common condition affecting the peripheral nervous system in which there is ineffectiveness of the local anesthetic lidocaineinattentionmuscle crampsandin femalespremenstrual syndromePMSThis condition begins in childhood and affectsof the entire populationmillion people in the USAAvailability of this test will allow major improvement in diagnosis and treatment of people currently diagnosed as having ADHDPMSanddental anxietyand by reducing use of stimulant drugswill reduce drug abuse