LUM-201 for Growth Hormone Deficiency (OraGrowtH210 Trial)

"Affirmative. Clinicaltrials.gov has documented that this investigation, which was initially posted on the 31st of December 2020, is currently recruiting participants. Approximately 80 people across 32 sites are needed to complete the trial."

"Although no specific efficacy data has been reported, the safety profile of LUM-201 is still well established enough to receive a score of 2."

"This trial will span a 6-month period and seek to measure the Percentage of subjects chosen by PEM strategy that meet growth targets. Additionally, secondary objectives include comparing AHVs achieved with daily rhGH and three LUM-201 dosage levels over 6 months, Height SDS changes, as well as GH peak serum concentrations in response to single doses of LUM-201."

"LUM-201 has proven to be a successful intervention for general surgery, short stature, and open epiphyses."

"Since 2005, the development of LUM-201 has been subject to 209 trials. Currently, there are 34 ongoing experiments involving 151 cities and 41 nations. BioPartners GmbH's initial study was conducted in 2005 with 144 participants and concluded its final phase 3 drug approval stage."

"Currently, 34 research projects are actively being conducted with LUM-201. Of these studies, 13 have entered Phase 3 of their trials. Philadelphia is the epicentre for this research; however, there exist 565 other clinical trial sites throughout the nation."

"This medical trial only permits patients aged 3 to 12 years old. Clinicialtrials.gov hosts 44 trials for minors and 37 for elderly adults."

"According to the details posted on clinicaltrials.gov, this trial is open for registration and continues to be actively edited - with its most recent update occuring in October 5th of 2022. The study was initially made available on December 31st 2020."

"For this medical trial, 32 different centres are recruiting patients. Notable locations include Cook Children's Medical Center in Fort Worth, Van Meter Pediatric Endocrinology P.C. in Atlanta and Rady Children's Hospital in San Diego amongst other enrolment sites."

"This clinical trial seeks to recruit 80 minors affected by endocrine system disorders who meet the following criteria: 1) established diagnosis of idiopathic PGHD, 2) naive-to-treatment and prepubertal status, 3) height standard deviation score ≤ -2.0 or ≥ 2 SD below mean parental HT-SDS, 4) baseline growth rate < 5.5 cm/year based on 6 months of data collection; bone age delayed by at least 6 months relative to chronological age for both genders; Tanner Stage I breast development in female participants and testicular volume <4 mL in male patients; negative SHOX genetic"