Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)

Study Overview
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Brief Summary
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This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be eligible for this study.

Detailed Description
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This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the optimal dose selected after the phase 2b part of MCS-2-US-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.

Official Title
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Open-Label, Six-Month Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects

Conditions
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Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: MCS-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has completed 12 weeks of treatment under the protocol MCS-2-US-a. Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study. Exclusion Criteria: Subject has severe LUTS at the last visit under the protocol MCS-2-US-a. Subject is considered ineligible for the study by the investigator(s).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCS-2<br> | Drug: MCS-2<br>* 15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a.<br>* Other names: MUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAE) |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in International Prostate Symptom Score (I-PSS) |  | 36 weeks | 
| Changes from baseline in urine flow rate |  | 36 weeks | 
| Changes from baseline in serum lycopene levels |  | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, MCS-2, Multi-Carotenoids, Lower Urinary Tract Symptoms, International prostate symptom score