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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
Must not have
Muscle disorder
Liver dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial tests a medication in patients with a condition where the body doesn't respond well to hormones to help their bodies respond better.

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.
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.
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
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I have been diagnosed with PHP1A or PHP1B.
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I am older than 5 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a muscle disorder.
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I have liver problems.
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I have severe heart disease.
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I am not taking any medications that interact with theophylline.
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I have kidney stones.
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I currently have an infection.
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I have a neurological condition.
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I have kidney disease.
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I have a peptic ulcer.
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I have seizures that are not controlled by medication.
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I have a bleeding disorder.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of Theophylline on Bone Age in PHP

Side effects data

From 2018 Phase 4 trial • 1670 Patients • NCT02261727
32%
COPD Exacerbation - not hospitalised
15%
COPD Exacerbation - Hospitalised
5%
Upper Respiratory Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Theophylline and Prednisone Arm
Low-dose Theophylline Arm
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Primary Hyperparathyroidism (PHPT) is commonly treated through surgical and pharmacologic approaches. The primary surgical treatment is parathyroidectomy, which involves the removal of the overactive parathyroid gland(s) to normalize calcium levels. Pharmacologic treatments include calcimimetics like cinacalcet, which enhance the sensitivity of the calcium-sensing receptors on the parathyroid gland, thereby reducing parathyroid hormone (PTH) secretion. Bisphosphonates and denosumab are used to manage bone density by inhibiting bone resorption. These treatments are crucial for PHPT patients as they help manage hypercalcemia and prevent complications such as osteoporosis, kidney stones, and cardiovascular issues.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,010 Previous Clinical Trials
13,308,920 Total Patients Enrolled
1 Trials studying Pseudohypoparathyroidism
6 Patients Enrolled for Pseudohypoparathyroidism
AMITA SHARMA, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Theophylline (Methylxanthine) Clinical Trial Eligibility Overview. Trial Name: NCT03718403 — Phase 4
Pseudohypoparathyroidism Research Study Groups: Single arm open labeled intervention study
Pseudohypoparathyroidism 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
~52 spots leftby Apr 2030
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