Phase 2 Study of Theophylline Treatment for Pseudohypoparathyroidism

Who is this study for? Child 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, characterized by early-onset obesity, short stature and resistance to multiple hormones. This phase 2 clinical trial and open-label extension study will test the efficacy of theophylline, a phosphodiesterase inhibitor, in pseudohypoparathyroidism. We hypothesize that theophylline will cause weight loss, slow the rate of growth plate closure and decrease hormone resistance in children.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 12
Healthy Volunteers: f
View:

• Age 2 to 12 years old

• Clinical diagnosis of PHP (per the EuroPHP network classification guidelines5): Presence of PTH resistance and/or ectopic ossification 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
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Jenny Leshko, RN
jenny.leshko@vumc.org
6153438116
Backup
Ashley Shoemaker, MD
ashley.h.shoemaker@vumc.org
6153438116
Time Frame
Start Date: 2020-07-13
Estimated Completion Date: 2026-12-31
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: Placebo
Placebo capsule by mouth once daily or Placebo elixir by mouth q6h
Authors
Ashley Shoemaker
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov

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