Phase 2 Study of Tanezumab in Subjects With Moderate to Severe Pain Due to Schwannomatosis

Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neurilemmoma
• Neurofibromatoses
• Pain
• Schwannomatosis
• Skin Neoplasms

• NCT number: NCT04163419
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 30, 2020
• Completion date: September 30, 2024