Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05435742
Status:
TERMINATED
Last Update Posted:
2024-04-12
First Post:
2022-06-14
Brief Title:
SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy CIPN
Sponsor:
Sonnet BioTherapeutics
Organization:
Sonnet BioTherapeutics
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 1b2a Study to Evaluate the Safety Tolerability and Efficacy of Repeated Subcutaneous Administration of SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy CIPN After the End of Chemotherapeutic Treatment
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will be conducted in adult patients with Chemotherapy-induced Peripheral Neuropathy CIPN that has been persistent for at least 3 months following completion of chemotherapy A total of 60 patients will be enrolled in equal numbers of a placebo group and two different SON-080 dose groups Treatment period will be 12 weeks long and patients will be followed-up for an additional 12 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None