A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
13
Paltusotine, capsules, once daily by mouth
Placebo, capsules, once daily by mouth
Ohio State University
Columbus, Ohio, United States
The Research Institute of Dallas
Dallas, Texas, United States
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, Brazil
Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13
Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal \[ULN\])
Time frame: 13 Weeks
Change in IGF-1 Levels
Change in IGF-1 levels between RWP Baseline/Week 10 and Week 13
Time frame: From Week 10 to Week 13
Change in Growth Hormone (GH) Levels
Change in growth hormone levels between RWP Baseline/Week 8 and Week 13
Time frame: From Week 8 to Week 13
Change in Total ASD Score Between RWP Baseline/Week 10 and Week 13
Measured by total Acromegaly symptom diary (ASD) score from W10-W13. ASD is a sponsor-developed daily diary to assess important acromegaly symptoms from the patient perspective. It covers 7 symptoms (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, and numbness or tingling). Patients rate the severity of each experience in the past 24 hours on an 11-point numeric scale that ranges from 0 (no symptom) to 10 (worst symptom). A weekly average ASD score is calculated for each item as the sum of the item responses for a specific item over the course of the study week divided by the number of days on which the item was completed. The weekly average ASD total score is calculated by computing the sum of the weekly average item scores for the 7 items (total range from 0 to 70), where higher score = higher symptom severity.
Time frame: From Week 10 to Week 13
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CPQuali Pesquisa Clinica
São Paulo, Brazil
General Hospital of Athens "Gennimatas"
Athens, Greece
Semmelweis University Faculty of Medicine
Budapest, Hungary
University of Pécs Medical School
Pécs, Hungary
Endocrine, Diabetes and Research Centre, Wellington Hospital
Wellington, New Zealand
The Centre of Postgraduate Medical Education
Warsaw, Poland
Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
Belgrade, Serbia
...and 1 more locations