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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03718403
Other study ID # Theophylline in PHP
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 11, 2019
Est. completion date April 10, 2032

Study information

Verified date July 2022
Source Massachusetts General Hospital
Contact AMITA SHARMA, MD
Phone 6177262908
Email asharma5@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 10, 2032
Est. primary completion date April 10, 2030
Accepts healthy volunteers No
Gender All
Age group 5 Years to 21 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of Theophylline on Bone Age in PHP Change in Bone age ( in years and months) before and after theophylline administration for 52 weeks 52 weeks