MCS in the Treatment of Lower Urinary Tract Symptoms

Study Overview
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Brief Summary
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The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Detailed Description
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This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate. Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2. Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).

Official Title
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An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects

Conditions
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Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: MCS-2 15 mg/day
* Drug: MCS-2 30 mg/day
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≧ 40 years old Not being treated for BPH or LUTS PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer I-PSS ≥ 10 No known malignancy AST/ALT ≦ 3X UNL Creatinine ≦ 3X UNL Subjects who sign the informed consent form Exclusion Criteria: Subjects' LUTS are not BPH-related Have been treated with pelvis irradiation or pelvic surgery Plan to undergo any invasive procedures within the study period Active infection or inflammation Considered ineligible by the investigators

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Both the phase 2b and phase 3 parts of the study have the placebo arm. | Drug: Placebo<br>* Two matching placebo soft-gel capsules, oral daily for 12 weeks.<br>* Other names: MCS matching placebo;|
| Active Comparator: MCS-2 15 mg/day<br>For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage. | Drug: MCS-2 15 mg/day<br>* One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.<br>* Other names: MUS;Drug: MCS-2 30 mg/day<br>* Two MCS-2 soft-gel capsules, oral daily for 12 weeks.<br>* Other names: MUS;|
| Active Comparator: MCS-2 30 mg/day<br>For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage. | Drug: MCS-2 15 mg/day<br>* One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.<br>* Other names: MUS;Drug: MCS-2 30 mg/day<br>* Two MCS-2 soft-gel capsules, oral daily for 12 weeks.<br>* Other names: MUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in International Prostate Symptom Scores |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in I-PSS subscores |  | 12 weeks | 
| Changes in I-PSS QOL index |  | 12 weeks | 
| Changes in urine flow rate |  | 12 weels | 
| Incidence of treatment-emergent adverse events (TEAE) |  | 12 weeks | 
| Incidence of withdrawals due to TEAEs |  | 12 weeks | 

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