Theophylline for Treatment of Pseudohypoparathyroidism
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|ClinicalTrials.gov Identifier: NCT04240821|
Recruitment Status : Enrolling by invitation
First Posted : January 27, 2020
Last Update Posted : August 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pseudohypoparathyroidism Pseudohypoparathyroidism Type 1a Albright Hereditary Osteodystrophy||Drug: Theophylline ER||Phase 2|
- The primary objective of this study is to evaluate the long-term safety of theophylline in patients with PHP.
- The secondary objectives of this study are to evaluate changes in BMI, hormone resistance and epiphyseal closure associated with theophylline treatment of patients with PHP.
Study Design The proposed study is a single center, 24-month open label extension clinical trial for patients with PHP who complete the randomized clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open-label extension study|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Extension Study of Theophylline for Treatment of Pseudohypoparathyroidism|
|Actual Study Start Date :||May 22, 2020|
|Estimated Primary Completion Date :||June 30, 2025|
|Estimated Study Completion Date :||June 30, 2025|
Experimental: Open-label theophylline
Oral theophylline - either once daily capsule or q6h elixir.
Drug: Theophylline ER
Other Name: Theophylline elixir
- Adverse Events [ Time Frame: 24 months ]Treatment-emergent adverse events will be compared before and during treatment
- BMI [ Time Frame: 24 months ]Change in BMI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240821
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Ashley Shoemaker, MD||Vanderbilt University Medical Center|