Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
(TELEPATH Trial)
Recruiting in Palo Alto (17 mi)
+39 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Lexicon Pharmaceuticals
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
Research Team
PL
Pablo Lapuerta, MD
Principal Investigator
Lexicon Pharmaceuticals, Inc.
Eligibility Criteria
Inclusion Criteria
Ongoing participation in a Phase 2 [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415)] or Phase 3 [LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)] study
Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of <1% per year) during the study and for 12 weeks after the Follow-up visit.
Ability and willingness to provide written informed consent
Treatment Details
Interventions
- Telotristat etiprate (Serotonin Synthesis Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 500 mg Telotristat EtiprateExperimental Treatment1 Intervention
Two telotristat etiprate (250 mg) tablets administered three times daily.
Group II: 250 mg Telotristat EtiprateExperimental Treatment1 Intervention
One telotristat etiprate (250 mg) tablet administered three times daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lexicon Pharmaceuticals
Lead Sponsor
Trials
67
Recruited
24,400+
Dr. Mike Exton
Lexicon Pharmaceuticals
Chief Executive Officer
PhD in Neuroscience from the University of Newcastle and PhD in Immunology from the University of Essen, Germany
Dr. Craig Granowitz
Lexicon Pharmaceuticals
Chief Medical Officer since 2021
MD