At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 enrolled
Drug / intervention
Paltusotinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge)
In Brief
A Phase 2 clinical trial evaluating Paltusotine for Acromegaly. Completed, enrolled 47 participants across 26 sites in 12 countries.
Detailed Summary
An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesBrazil, Germany, Greece, Hungary, Italy, New Zealand, Poland, Romania, Serbia, Slovakia, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartMar 2019
Primary CompletionAug 2020
Study CompletionAug 2020
TodayJul 2026
First PostedDec 28, 2018
Enrollment StartMar 12, 2019
Primary CompletionAug 3, 2020
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.5 years ago
Interventions
Paltusotinedrug
Paltusotine, capsules, once daily by mouth