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Phosphodiesterase Inhibitor

Theophylline for Pseudohypoparathyroidism

Phase 2
Recruiting
Led By Ashley Shoemaker, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obesity (BMI >95th percentile for age/gender and/or ≥30 kg/m2)
Age 13 years and above
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial will test if theophylline can help people with pseudohypoparathyroidism by causing weight loss, improved glucose tolerance, and slower growth plate closure.

Who is the study for?
This trial is for individuals aged 13 and above with a clinical diagnosis of pseudohypoparathyroidism, who are significantly overweight. They must not have liver problems, heart arrhythmias (except slow heartbeat), untreated low thyroid hormone levels, active stomach ulcers, severe psychiatric disorders including recent major depression or suicidal behavior, heart failure, pregnancy plans within a year, or be using certain other medications.Check my eligibility
What is being tested?
The study is testing theophylline's effectiveness in treating pseudohypoparathyroidism by comparing it to a placebo. The goal is to see if theophylline can help with weight loss, improve blood sugar control and affect bone growth in children and young adults.See study design
What are the potential side effects?
Potential side effects of theophylline include insomnia, gastrointestinal discomforts like nausea or diarrhea, increased heart rate palpitations or irregularities; nervousness; headaches; and potentially more serious effects if levels get too high.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am considered obese based on my BMI.
Select...
I am 13 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in body mass index
Secondary outcome measures
Change in insulinogenic index
change in calcitriol dose
change in levothyroxine dose
Other outcome measures
Change in BMI
Change in body mass index z-score

Side effects data

From 2018 Phase 4 trial • 1670 Patients • NCT02261727
32%
COPD Exacerbation - not hospitalised
16%
COPD Exacerbation - Hospitalised
7%
Upper Respiratory Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Low-dose Theophylline Arm
Theophylline and Prednisone Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TheophyllineExperimental Treatment1 Intervention
Theophylline capsules by mouth once daily or Theophylline elixir by mouth q6h (dose determined by serum drug levels)
Group II: PlacebosPlacebo Group1 Intervention
Theophylline capsule by mouth once daily or Theophylline elixir by mouth q6h
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Theophylline
FDA approved

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,158 Total Patients Enrolled
4 Trials studying Pseudohypoparathyroidism
93 Patients Enrolled for Pseudohypoparathyroidism
Harvard UniversityOTHER
229 Previous Clinical Trials
474,549 Total Patients Enrolled
Ashley Shoemaker, MDPrincipal Investigator - Vanderbilt University Medical Center
Monroe Carell Jr. Children's Hospital, Vanderbilt University
4 Previous Clinical Trials
3,107 Total Patients Enrolled
3 Trials studying Pseudohypoparathyroidism
107 Patients Enrolled for Pseudohypoparathyroidism

Media Library

Theophylline (Phosphodiesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03029429 — Phase 2
Pseudohypoparathyroidism Research Study Groups: Theophylline, Placebos
Pseudohypoparathyroidism Clinical Trial 2023: Theophylline Highlights & Side Effects. Trial Name: NCT03029429 — Phase 2
Theophylline (Phosphodiesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03029429 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients who are over 45 years of age eligible for this research project?

"Eligibility for this clinical trial is based on age, with participants needing to be between 13 and 99 years old."

Answered by AI

Is it legal to market and sell Theophylline in the United States?

"Theophylline's safety is supported by some data, making it a 2 on our 1-3 scale."

Answered by AI

Could you please share Theophylline's clinical trial history?

"There are currently 6 ongoing clinical trials studying Theophylline. Out of these, 2 have reached Phase 3 status. Most studies related to Theophylline are based in Nashville, but there are a total of 7 locations running trials for this medication."

Answered by AI

What medical conditions is Theophylline used to treat?

"Theophylline is an effective treatment for emphysema, bronchoconstriction, and chronic bronchial inflammation."

Answered by AI

Can I join this medical study?

"Researchers conducting this trial are looking for 34 individuals that have pseudohypoparathyroidism and meet the age criteria of being between 13 and 99 years old. Most importantly, potential participants must also suffer from obesity as defined by having a BMI in the 95th percentile or higher for their age and gender group or having a body weight 30 kilograms per square meter."

Answered by AI

Is this research still looking for volunteers?

"Yes, the trial is still active and recruitment information can be found on clinicaltrials.gov. This particular study was first made available on September 1st, 2018 and has since been updated on August 15th, 2022. They are currently looking for 34 participants total at a single site."

Answered by AI

How many people suffering from this ailment will be given the chance to try this new treatment?

"That is correct. The clinical trial listing on the website shows that this research project is actively seeking participants. This study was originally posted on September 1st, 2018 and was updated August 15th, 2022. Currently, 34 patients are needed to be enrolled at a single site."

Answered by AI
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~9 spots leftby Jul 2026