Phase 2 Study of Theophylline Treatment for Pseudohypoparathyroidism

Who is this study for? Child to adult patients with Pseudohypoparathyroidism
What treatments are being studied? Theophylline
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Pseudohypoparathyroidism is a genetic disorder with limited treatment options. Patients have early-onset obesity, short stature and increased risk of type 2 diabetes. This phase 2 clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in pseudohypoparathyroidism. The investigators hypothesize that theophylline will cause weight loss, improve glucose tolerance and slow growth plate closure in children and young adults.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 99
Healthy Volunteers: f
View:

• Age 13 years and above

• Clinical diagnosis of PHP (per the EuroPHP network classification guidelines1): Presence of PTH resistance or ectopic classification OR brachydactyly type E plus 2 minor criteria (TSH resistance, other hormonal resistance, developmental delay, intrauterine or post-natal growth retardation, obesity/overweight, specific facial features)

• Obesity (BMI \>95th percentile for age/gender and/or ≥30 kg/m2)

Locations
United States
Tennessee
Ashley Shoemaker
RECRUITING
Nashville
Contact Information
Primary
Jenny Leshko, RN
jenny.leshko@vumc.org
6153438116
Backup
Ashley Shoemaker
ashley.h.shoemaker@vumc.org
6153438116
Time Frame
Start Date: 2018-09-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 34
Treatments
Experimental: Theophylline
Theophylline capsules by mouth once daily or Theophylline elixir by mouth q6h (dose determined by serum drug levels)
Placebo_comparator: Placebos
Theophylline capsule by mouth once daily or Theophylline elixir by mouth q6h
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: Harvard University

This content was sourced from clinicaltrials.gov