1 Study Matches
A Multicenter, 24-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Idiopathic Growth Hormone Deficiency (GHD)
This is a randomized drug study that will examine if there is a difference between a daily oral LUM- 201 (study drug) and the standard of care drug, Norditropin, over a 24 month period in children, who have not received treatment for Growth Hormone Deficiency (GHD)
Younger than 18 years old
Inclusion Criteria:Have an established diagnosis of PGHD. Eligible subjects must be naïve-to-treatment and be prepubertal.
At Screening, be age ≥ 3.0 years and age < 10.0 years for girls and < 11.0 years for boys
Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 30 days prior to Day 1.
Exclusion Criteria:A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and/or use of medication to treat ADHD
Evidence or history of an intracranial mass
Children's Health, Diabetes & Hormones