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Phosphodiesterase Inhibitor

Theophylline for Pseudohypoparathyroidism

Phase 2

Waitlist Available

Led By Ashley Shoemaker, MD

Research Sponsored by Ashley Shoemaker

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will test if theophylline can help with pseudohypoparathyroidism, a disorder with limited treatment options that causes obesity, short stature, hormone resistance, and cognitive impairment.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects of Theophylline may include nervousness, trouble sleeping, increased urination, stomach upset and occasionally more serious effects like irregular heartbeat or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Secondary outcome measures

BMI

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-label theophyllineExperimental Treatment1 Intervention

Oral theophylline - either once daily capsule or q6h elixir.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Theophylline

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ashley ShoemakerLead Sponsor

Ashley Shoemaker, MDPrincipal InvestigatorVanderbilt University Medical Center

4 Previous Clinical Trials

3,107 Total Patients Enrolled

3 Trials studying Pseudohypoparathyroidism

107 Patients Enrolled for Pseudohypoparathyroidism

Media Library

Theophylline ER (Phosphodiesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04240821 — Phase 2

Pseudohypoparathyroidism Research Study Groups: Open-label theophylline

Pseudohypoparathyroidism Clinical Trial 2023: Theophylline ER Highlights & Side Effects. Trial Name: NCT04240821 — Phase 2

Theophylline ER (Phosphodiesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04240821 — Phase 2

Frequently Asked Questions

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

How many participants are engaged in this clinical experiment?

"Alas, this medical study is no longer searching for patients. Initially posted on May 22nd 2020, it was last updated 8/15/2022. If you are interested in other studies related to pseudohypoparathyroidism and Theophylline ER there are respectively 6 and six trials actively recruiting participants."

Answered by AI

Are patients still being admitted to this trial?

"The information found on clinicaltrials.gov indicates that this particular medical trial is not currently seeking participants. It was first posted on May 22nd 2020 and last edited August 15th 2022; however, there are 12 other trials actively recruiting individuals at the moment."

Answered by AI

What is the current status of Theophylline ER's authorization by the FDA?

"Theophylline ER was assigned a risk rating of 2, due to being in the Phase 2 trial stage; there is existing data proving safety but none confirming effectiveness."

Answered by AI

Are individuals aged 60 and above eligible for this experiment?

"The requirements for taking part in this trial stipulate that participants are aged between 2 and 99. In addition, 10 different studies exist to support individuals below 18 years old, with a further 7 clinical trials catering to those over 65."

Answered by AI

Are there any additional research endeavors involving Theophylline ER?

"At present, there are 6 Theophylline ER studies taking place. 2 of those trials have reached Phase 3 status while the others remain at earlier stages. 7 trial sites can be found in and around Nashville, Tennessee."

Answered by AI

Is it possible for me to participate in this research initiative?

"This clinical trial is seeking around 34 people with pseudohypoparathyroidism between the ages of 2 and 99. Those who qualify for this study will be able to participate."

Answered by AI