NCT04447729

A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain Syndrome

A Multicenter, Open-label Pilot Study of the Efficacy and Safety of Fremanezumab for Treatment of Female Patients With Interstitial Cystitis-Bladder Pain Syndrome

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy of fremanezumab in reducing pain in patients with interstitial cystitis-bladder pain syndrome (IC-BPS). A secondary efficacy objective of the study is to evaluate the effect of fremanezumab on other efficacy measures, including pain, voiding frequency, urinary symptoms, and quality of life. And another secondary objective of the study is to evaluate the safety and tolerability of fremanezumab administered subcutaneously in adult patients with IC-BPS. The planned active study period is 8 weeks; the entire planned study duration for each patient is 13 weeks.

Conditions

• Interstitial Cystitis

Interventions

Type	Name	Description
DRUG	fremanezumab	Two doses, each dose consists of 4 injections with prefilled syringes

Timeline

• Start date: 2020-10-15
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2020-06-25
• Last updated: 2021-11-09

Regulatory

• FDA-regulated drug study