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Phosphodiesterase Inhibitor

Theophylline for Pseudohypoparathyroidism

Q: What health issues is Theophylline typically utilized to address?

<p>Generally, theophylline is administered to treat <a href="https://www.withpower.com/clinical-trials/emphysema">emphysema</a>. It may also be effective in curbing bronchoconstriction, chronic inflammation of the airways and pulmonary bronchitis.</p>

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 2 to 12 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 52 weeks

Awards & highlights

Study Summary

This trial will test if theophylline can help with weight loss, growth plate closure, and hormone resistance in children with pseudohypoparathyroidism, a disorder with limited treatment options.

Who is the study for?

This trial is for children aged 2-12 with pseudohypoparathyroidism, characterized by obesity and hormone resistance. They must meet specific criteria including a BMI >95th percentile or ≥30 kg/m2 and have certain symptoms of the disorder. Kids can't join if they have untreated thyroid issues, liver problems, heart failure, are pregnant or planning to be, have had severe psychiatric disorders including depression in the last 2 years, smoke cigarettes or abuse alcohol.Check my eligibility

What is being tested?

The study tests Theophylline against a placebo to see if it helps with weight loss and reduces hormone resistance in kids with pseudohypoparathyroidism. It's a phase 2 trial where some kids will get the real drug while others will get an inactive substance without knowing which one they're taking.See study design

What are the potential side effects?

Possible side effects of Theophylline include stomach upset, increased heart rate (arrhythmia), nervousness, trouble sleeping (insomnia), headache and dizziness. Severe reactions might involve seizures or irregular heartbeat.

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 between 2 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 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

Calcitriol

Change in epiphyseal closure

Change in levothyroxine dose

Side effects data

From 2018 Phase 4 trial • 1670 Patients • NCT02261727

32%

COPD Exacerbation - not hospitalised

16%

COPD Exacerbation - Hospitalised

Upper Respiratory Tract Infection

100%

80%

60%

40%

20%

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: PlaceboPlacebo Group1 Intervention

Placebo capsule by mouth once daily or Placebo elixir by mouth q6h

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Theophylline

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,159 Total Patients Enrolled

4 Trials studying Pseudohypoparathyroidism

93 Patients Enrolled for Pseudohypoparathyroidism

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: NCT04551170 — Phase 2

Pseudohypoparathyroidism Research Study Groups: Theophylline, Placebo

Pseudohypoparathyroidism Clinical Trial 2023: Theophylline Highlights & Side Effects. Trial Name: NCT04551170 — Phase 2

Theophylline (Phosphodiesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04551170 — Phase 2

Frequently Asked Questions

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

Is this clinical experiment recruiting participants at the present time?

"According to the data on clinicaltrials.gov, enrollment for this trial is still open with a posting date of July 13th 2020 and an edit date of October 4th 2022."

Answered by AI

What health issues is Theophylline typically utilized to address?

"Generally, theophylline is administered to treat emphysema. It may also be effective in curbing bronchoconstriction, chronic inflammation of the airways and pulmonary bronchitis."

Answered by AI

How many participants are taking part in this research endeavor?

"Affirmative. Clinicaltrials.gov corroborates that this clinical trial is in the process of recruiting patients. First posted on July 13th 2020, and most recently updated October 4th 2022, it seeks 34 individuals at a single site."

Answered by AI

Do I qualify to join in this experiment?

"This medical trial is looking to enroll 34 children between the ages of two and twelve. The only prerequisite for potential participants is that they must have pseudohypoparathyroidism."

Answered by AI

To what degree has Theophylline been investigated before?

"Currently, 6 clinical trials for Theophylline are underway with 2 studies in the last phase of development. Most of these take place in Nashville, but there is a total of 7 locations where related research is being conducted."

Answered by AI