Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04163419
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2019-11-12
Brief Title:
Phase 2 Study of Tanezumab in Subjects With Moderate to Severe Pain Due to Schwannomatosis
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-Controlled Study of the Analgesic Efficacy and Safety of the Subcutaneous Administration of the Anti-NGF Antibody Tanezumab in Subjects With Moderate to Severe Pain Due to Schwannomatosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine whether the administration of tanezumab an anti-nerve growth factor NGF antibody improves pain relief in schwannomatosis patients receiving background non-NSAID therapy
Detailed Description:
Schwannomatosis is characterized by the predisposition to develop multiple schwannomas and less commonly meningiomas Pain is the most frequent symptom reported by these patients with 68 experiencing chronic pain
The investigators propose to test the efficacy and tolerability of tanezumab as a treatment for schwannomatosis patients with chronic pain who have had inadequate pain relief in a randomized placebo-controlled trial which could form the basis of a larger randomized controlled trial in the future
The study is designed with a total duration of 281 days 40 weeks and will consist of four periods Pre-treatment Double-Blind Treatment Single Arm Treatment and 24-Week Safety Follow-up The Pre-Treatment Period lasting up to 30 days followed by a Double-Blind Treatment Period lasting up to 8 weeks followed by a Single Arm Treatment Period lasting up to 8 weeks and a 24-Week Safety Follow-Up Period ending with the End of Study Visit at Week 40
The investigators propose to test the efficacy and tolerability of tanezumab as a treatment for schwannomatosis patients with chronic pain who have had inadequate pain relief in a randomized placebo-controlled trial which could form the basis of a larger randomized controlled trial in the future
The study is designed with a total duration of 281 days 40 weeks and will consist of four periods Pre-treatment Double-Blind Treatment Single Arm Treatment and 24-Week Safety Follow-up The Pre-Treatment Period lasting up to 30 days followed by a Double-Blind Treatment Period lasting up to 8 weeks followed by a Single Arm Treatment Period lasting up to 8 weeks and a 24-Week Safety Follow-Up Period ending with the End of Study Visit at Week 40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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