Trial Summary
What is the purpose of this trial?
This trial will test theophylline, a medication that helps relax muscles, in children and young adults with a genetic disorder called pseudohypoparathyroidism. The goal is to see if it can help them lose weight, handle sugar better, and respond better to hormones.
Research Team
Ashley Shoemaker, MD, MSCI
Principal Investigator
Vanderbilt University Medical Center
Eligibility Criteria
This trial is for children and young adults who have completed a previous theophylline study for pseudohypoparathyroidism. It's not open to those with seizure disorders, liver issues, active ulcers, heart failure, arrhythmias (except bradycardia), or those on certain meds. Pregnant individuals, smokers and heavy drinkers are also excluded.Inclusion Criteria
Successful completion of the randomized clinical trial "Phase 2 Study of Theophylline Treatment of Pseudohypoparathyroidism IND 133103 (11/1/2016)"
Exclusion Criteria
You are currently smoking cigarettes or abusing alcohol.
Unable to comply with study procedures in the opinion of the investigator
I have been diagnosed with congestive heart failure.
See 7 more
Treatment Details
Interventions
- Theophylline ER (Phosphodiesterase Inhibitor)
Trial OverviewThe trial is testing if Theophylline ER can help with weight loss, glucose tolerance and hormone resistance in patients with pseudohypoparathyroidism. This phase 2 trial follows up from an earlier study to further evaluate the drug's effectiveness.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open-label theophyllineExperimental Treatment1 Intervention
Oral theophylline - either once daily capsule or q6h elixir.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ashley Shoemaker
Lead Sponsor
Trials
1
Recruited
30+