NCT02326454

A Placebo Controlled Study of MR901 (Talaporfin Sodium Sodium + a Drug-activating Device) for the Relief of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

A Phase 2 Randomised, Double-blind, Placebo Controlled, Study of MR901 in Patients With Moderate to Severe Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Light Sciences Oncology · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the safety and efficacy of a photosensitive drug (talaporfin sodium) activated by an intraurethrally placed drug-activating device. MR901 is a code used to identify the combination of talaporfin sodium and the drug-activating device. Two different light doses will be tested against placebo groups in this 4-arm study.

Detailed description

At least 192 patients with moderate-to-severe LUTS caused by BPH will be randomized in a 2:2:1:1 ratio to receive a single treatment of talaporfin sodium activated by light at one of two light doses or placebo (saline) with light at either dose. Follow-up is planned for 52 weeks from the day of treatment, with assessment at 12 weeks for change in International Prostate Symptom Score and continued follow-up during the remaining 40 weeks to assess duration of effect, need for any intervention, and longer-term safety.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	talaporfin sodium	1 mg/kg
DRUG	Saline
DEVICE	Drug Activator 100 J/cm	Light Dose: 100 J/cm
DEVICE	Drug Activator 200 J/cm	Light Dose: 200 J/cm

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-03-29
• Completion: 2017-03-29
• First posted: 2014-12-29
• Last updated: 2018-08-08

Locations

41 sites across 1 country: United States