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Methylxanthine

Theophylline for Pseudohypoparathyroidism

Phase 4

Recruiting

Led By AMITA SHARMA, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Subjects with known diagnosis of PHP1A and PHP1B

Age >5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

This trial looks at whether theophylline can help people with Pseudohypoparathyroidism.

Who is the study for?

This trial is for people over the age of 5 with a confirmed diagnosis of Pseudohypoparathyroidism types PHP1A and PHP1B. It's not suitable for those with muscle disorders, peptic ulcers, severe heart conditions, uncontrolled seizures, liver issues, bleeding problems, kidney stones or diseases, allergies to theophylline, infections or other neurological diseases.Check my eligibility

What is being tested?

The study is testing the effects of a drug called Theophylline on individuals with Pseudohypoparathyroidism. A total of 100 participants will be involved to see how this medication influences their condition.See study design

What are the potential side effects?

Possible side effects from taking Theophylline may include stomach discomforts like nausea and vomiting; restlessness; sleep disturbances; faster heartbeat; occasional headaches and irritability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PHP1A or PHP1B.

Select...

I am older than 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

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

Effect of Theophylline on Bone Age in PHP

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

1Treatment groups

Experimental Treatment

Group I: Single arm open labeled intervention studyExperimental Treatment1 Intervention

Subjects with PHP will be given theophylline to decrease the end organ resistance by increasing levels of cAMP, a second messenger. Theophylline will be dosed twice a day for a period of 52 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Theophylline

2008

Completed Phase 4

~2950

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,381 Total Patients Enrolled

AMITA SHARMA, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Theophylline (Methylxanthine) Clinical Trial Eligibility Overview. Trial Name: NCT03718403 — Phase 4

Primary Hyperparathyroidism Research Study Groups: Single arm open labeled intervention study

Primary Hyperparathyroidism Clinical Trial 2023: Theophylline Highlights & Side Effects. Trial Name: NCT03718403 — Phase 4

Theophylline (Methylxanthine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03718403 — Phase 4

Frequently Asked Questions

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

What precedent has been set by past research surrounding Theophylline?

"Currently, 6 studies are underway that focus on Theophylline. Two of these trials have reached the third and final stage. Although several medical facilities in Nashville, Tennessee specialize in researching this substance, there is a total of 7 locations conducting such research across the nation."

Answered by AI

Is geriatric participation being considered for this clinical research?

"Within this trial, participants aged 5 to 21 are welcome and encouraged to join."

Answered by AI

How does Theophylline typically help to improve health outcomes?

"The primary medical intervention for emphysema is Theophylline, which can also help treat bronchoconstriction, chronic bronchial inflammation, and chronic bronchitis."

Answered by AI

What dangers have been linked to Theophylline consumption?

"Accurately, the safety of Theophylline has been assessed as a 3 due to its status as a Phase 4 trial, which indicates that it is officially approved."

Answered by AI

Who is most suited to enrolling in this experiment?

"To be considered for this study, participants must have php ib and stand between the ages of 5 to 21. A total of 100 volunteers are needed."

Answered by AI

Is enrollment for this experiment actively recruiting participants?

"Affirmative. According to clinicaltrials.gov, this medical trial is still recruiting participants who were first posted on November 11th 2019 and modified most recently on July 20th 2022. To fulfill its quota of 100 patients, the study needs enrollees from one site only."

Answered by AI

What is the upper boundary of individuals participating in this experiment?

"Affirmative. Clinicaltrials.gov reveals that the study, initially posted on November 11th 2019 and updated July 20th 2022, is actively recruiting patients from one location to reach a total of 100 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Theophylline in Pseudohypoparathyroidism

Amita Sharma 2019. "Effect of Theophylline in Pseudohypoparathyroidism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03718403.

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