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Recruiting NCT03718403

Effect of Theophylline in Pseudohypoparathyroidism

Phase IV Interventional PHP Ia PHP IB Php1C

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Theophylline.
Who it may be relevant to
Registry conditions: PHP Ia, PHP IB, Php1C. Basic parameters: 5 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism.

Detailed description

It is an open label intervention study for the off-label use of theophylline in psuedohypoparathyroidism (PHP).Theophylline is a is non-specific phosphodiesterase inhibitor which increases the levels of secondary messenger,cAMP. PHP patients have end organ resistance to hormones involving cAMP signaling. Thus, theophylline has a potential to abrogate hormone resistance. Also, it may have a role in bone maturation, neurocognition and metabolism.

Interventions

  • Drug Theophylline
    Theophylline will be given to maintain a peak level between 10-15 mcg/mL

Primary outcome measures

  • Effect of Theophylline on Bone Age in PHP [Time frame: 52 weeks]

Eligibility criteria

Inclusion criteria

  • Subjects with known diagnosis of PHP1A and PHP1B
  • Age >5 years

Exclusion criteria

  • • Significant kidney disease, i.e. any CKD stage
  • Hypercalciuria
  • Kidney stones
  • Severe Heart disease
  • Uncontrolled seizure disorder
  • Peptic ulcer
  • Liver dysfunction
  • Bleeding disorder
  • Allergy to theophylline preparation
  • Muscle disorder
  • Infection
  • Any neurologic disease
  • Chronic drugs interacting with theophylline

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT03718403 · Theophylline in PHP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗