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History of Changes for Study: NCT02326454
A Placebo Controlled Study of MR901 for the Relief of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Latest version (submitted August 6, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 22, 2014 None (earliest Version on record)
2 January 6, 2015 Study Status, Eligibility and Outcome Measures
3 February 27, 2015 Study Status and Contacts/Locations
4 March 19, 2015 Study Status and Contacts/Locations
5 March 25, 2015 Contacts/Locations and Study Status
6 April 2, 2015 Study Status and Contacts/Locations
7 April 30, 2015 Eligibility and Study Status
8 May 4, 2015 Study Status and Contacts/Locations
9 June 4, 2015 Study Status, Contacts/Locations, Eligibility and Outcome Measures
10 July 1, 2015 Study Status and Contacts/Locations
11 July 21, 2015 Eligibility, Outcome Measures and Study Status
12 August 21, 2015 Study Status and Contacts/Locations
13 October 27, 2015 Study Status and Contacts/Locations
14 October 29, 2015 Contacts/Locations and Study Status
15 November 13, 2015 Contacts/Locations and Study Status
16 December 17, 2015 Study Status and Contacts/Locations
17 February 1, 2016 Study Status and Contacts/Locations
18 March 17, 2016 Study Status and Contacts/Locations
19 April 6, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
20 May 16, 2016 Study Status and Contacts/Locations
21 January 11, 2017 Study Status
22 September 23, 2017 Recruitment Status, Study Status and Contacts/Locations
23 April 19, 2018 Study Status and Contacts/Locations
24 August 6, 2018 Study Status, Contacts/Locations, Arms and Interventions, Study Description and Study Identification
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Results Submission Events
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Study NCT02326454
Submitted Date:  December 22, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: MR901-2501
Brief Title: A Placebo Controlled Study of MR901 for the Relief of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Official Title: 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)
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2014
Overall Status: Recruiting
Study Start: November 2014
Primary Completion: March 2016 [Anticipated]
Study Completion: February 2017 [Anticipated]
First Submitted: December 16, 2014
First Submitted that
Met QC Criteria:
December 22, 2014
First Posted: December 29, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 22, 2014
Last Update Posted: December 29, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Light Sciences Oncology
Responsible Party: Sponsor
Collaborators: Mundipharma Research Limited
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study investigates the safety and efficacy of a photosensitive drug (talaporfin sodium) activated by an intraurethrally placed 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.
Open or close this module Conditions
Conditions: Benign Prostatic Hyperplasia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 192 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Talaporfin sodium/Light dose 100 J/cm
Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period
Drug: talaporfin sodium
1 mg/kg
Other Names:
  • LS11
  • NPe6
  • mono-(L)-aspartyl chlorin e6
  • ME2906
  • Laserphyrin
Device: Drug Activator 100 J/cm
Light Dose: 100 J/cm
Other Names:
  • Litx™ BPH Device
Active Comparator: Talaporfin sodium/Light dose 200 J/cm
Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours
Drug: talaporfin sodium
1 mg/kg
Other Names:
  • LS11
  • NPe6
  • mono-(L)-aspartyl chlorin e6
  • ME2906
  • Laserphyrin
Device: Drug Activator 200 J/cm
Light Dose: 200 J/cm
Other Names:
  • Litx™ BPH Device
Placebo Comparator: Saline/Light dose 100 J/cm
0.9% Sodium Chloride is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period
Drug: Saline
Other Names:
  • Placebo
Device: Drug Activator 100 J/cm
Light Dose: 100 J/cm
Other Names:
  • Litx™ BPH Device
Placebo Comparator: Saline/Light dose 200 J/cm
0.9% Sodium Chloride is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours.
Drug: Saline
Other Names:
  • Placebo
Device: Drug Activator 200 J/cm
Light Dose: 200 J/cm
Other Names:
  • Litx™ BPH Device
Open or close this module Outcome Measures
Primary Outcome Measures:
1. International Prostate Symptoms Score (IPSS) Questionnaire
[ Time Frame: 12 weeks ]

Change from baseline in the total International Prostate Symptom Score (IPSS, Questions 1-7)
Secondary Outcome Measures:
1. Modified International Prostate Symptoms Score (IPSS) Questionnaire
[ Time Frame: 1, 2 and 3 Weeks ]

Modified IPSS used to evaluate subject's average experience of symptoms over preceding 7 days.
2. Patient Global Impression of Improvement (PGI-1)
[ Time Frame: 4, 12, 26 and 52 weeks ]

The number of subjects in each of the 7 response categories will be collected by subject interview at all relevant time points
3. Clinical Global Impression of Improvement (CGI-1)
[ Time Frame: 4, 12, 26 and 52 weeks ]

The number of subjects in each of the 7 response categories will be assessed by the Investigator at all relevant time points.
4. Maximum Urinary Flow Rate (Qmax)
[ Time Frame: 1, 2, 3, 4, 12, 26 and 52 weeks ]

The maximum rate at which urine can be voided, as measured using free uroflowmetry using a double-voiding technique (two measurement 'runs') of at least 150mL each.
5. Post-void residual volume (PVR volume)
[ Time Frame: 1, 2, 3, 4, 12, 26 and 52 weeks ]

Measured post-voiding through insertion of a urinary catheter to complete bladder emptying
6. 3-Day Frequency/Volume Data
[ Time Frame: 1, 2, 3, 4, 12, 26 and 52 weeks ]

Data on urinary frequency and void volume will be collected by subjects for 3 days prior to each clinic visit
7. Safety and tolerability assessed by the number of subjects with Adverse Events
[ Time Frame: 52 weeks ]

Assessed by variables such as AEs, laboratory parameters, vital signs, ECGs
8. Prostate-specific Antigen (PSA)
[ Time Frame: 1, 2, 3, 4, 12, 26 and 52 weeks ]

As measured in serum, to detect any changes that may be caused by the effects of the therapeutic intervention under study on prostatic tissue.
9. Duration of effect/time to next treatment and treatment selected
[ Time Frame: 52 weeks ]

Subjects whose condition progresses such that an additional intervention is required during the 12-month study period may provide secondary evidence of efficacy, dependent upon their treatment allocation.
10. International Index of Erectile Function-15 (IIEF-15)
[ Time Frame: 4, 12, 26 and 52 weeks ]

15-item, 5 domain scale collected by subject interview, relating to the subjects' experience of erectile function (and other sexual parameters) over the previous 4 weeks).
11. Quality of Life evaluation - Bother Score
[ Time Frame: 1, 2, 3, 4, 12, 26 and 52 weeks ]

Question 8 of the IPSS (also known as the Bother Score), which asks the subject to state how he would feel if he had to spend the rest of his life with his urinary condition just the way it is now, according to a 7-point scale (from 0 = 'delighted' to 6 = 'terrible').
12. Over-active Bladder-V3 (OAB-V3)
[ Time Frame: 1, 2, 3, 4, 12, 26 and 52 weeks ]

OAB symptoms will be assessed, by subject interview, using the 3-item OAB Awareness Tool (OAB-V3), under which the subject reports how much they have been bothered by 3 symptoms of OAB (without a specified time period) according to a 6-point scale ranging from 0 (not at all) to 5 (a very great deal) (maximum score, 15).
13. International Prostate Symptoms Score (IPSS) Questionnaire
[ Time Frame: 4, 26 and 52 weeks ]

IPSS Total Score as Change from Baseline
14. IPSS Subscores.
[ Time Frame: 1, 2, 3, 4, 12, 26 and 52 weeks ]

The changes from baseline for each of the 7 IPSS questions, as well as the totals for each of the 2 categories of symptoms - voiding symptoms (incomplete emptying, intermittency, weak stream, straining) and storage symptoms (frequency, urgency and nocturia).
15. Prostate volume
[ Time Frame: 12 and 52 weeks ]

As measured on TRUS, to detect any changes that may be caused by the effects of the therapeutic intervention under study on prostatic volume.
16. Quality of Life evaluation - BPH Impact Index (BPHII)
[ Time Frame: 4, 12, 26 and 52 weeks ]

The BPHII asks the subject to assess the impact of four aspects of their urinary condition over the previous 4 weeks, according to a 4-point (questions 1 - 3) or 5-point scale (question 4) (maximum score, 13).
Open or close this module Eligibility
Minimum Age: 45 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion criteria:

  1. Males aged ≥45 years, weighing ≤200 Kg and able to provide written, informed consent.
  2. Documented symptoms of BPH-LUTS for 6 months or more.
  3. For patients regularly taking their prescribed medication, dose should have been stable for at least 6 months for 5-alpha reductase inhibitors and 3 months for others.
  4. For patients who have withdrawn from regularly taking their prescribed medication, there should have been a 6 month washout period for 5-alpha reductase inhibitors and 3 months for others.
  5. Have a total International Prostate Symptom Score (IPSS; Qs 1-7) of 15 -30 (inclusive).
  6. Prostate volume of 30 - 80 mL (inclusive).
  7. Maximum urinary flow rate (Qmax): 5 - 15 mL/sec (assessed on two voids of ≥ 150mL).
  8. Prostate-specific antigen (PSA) ≤10 ng/mL.
  9. Post-void residual (PVR) volume ≤200 mL.
  10. Prostatic urethral length (PUL) of between 30 - 55mm (inclusive).
  11. Willing and able to comply with photosensitivity precautions

Exclusion criteria

  1. Any history of minimally invasive or surgical treatment for BPH or any other prostatic condition.
  2. Subjects weighing >200 Kg.
  3. Subjects with a history or current evidence of any of the following:
    1. Active urinary tract infection i.e. must have a screening urinalysis without signs of infection or negative urine culture. Must not have had a previous symptomatic urinary tract infection within 4 weeks of the study.
    2. Urethral stricture or any other anatomical feature that would complicate catheterisation.
    3. Interstitial cystitis.
    4. Predominant middle lobe obstruction, as indicated by a degree of intra-vesical prostatic protrusion (IPP) on TRUS of >10mm.
    5. Prostate or bladder cancer or bladder carcinoma-in-situ - in particular, evidence from digital rectal exam (DRE) of prostate abnormalities suggestive of cancer in the last 12 months.
    6. Any other absolute indication for urosurgical intervention (such as acute or frequent retention, stones, untreated bladder stones, urethral strictures/bladder neck contracture (BNC)).
  4. PSA level in excess of >10 ng/ml. If the PSA measurement is 2.5-10 ng/ml and/or has shown a clinically significant concerning increase in the last 6 months, local standard of care must be pursued to ensure the possibility of prostate cancer has been followed up and ruled out prior to study entry.
  5. Subjects who had had a prostate biopsy within 6 weeks prior to Screening.
  6. Any neurological condition affecting the bladder or a history of a neurogenic or chronically decompensated bladder i.e. neurogenic bladder, Parkinson's disease, history of chronic prostatitis within the last 5 years.
  7. Prior treatment for urinary incontinence.
  8. Requirements for daily incontinence pads or devices.
  9. Subjects in whom nocturia is a predominant feature of their LUTS, including:
    1. Those in whom estimated >33% of their 24h urine output is voided at night.
    2. Those with an alternative potential cause for nocturia, such as congestive heart failure, hepatic failure, nephritic syndrome, sleep disorder.
  10. Subjects in whom the possibility of a concurrent over-active bladder exists, as indicated by:
    1. A score of 4 points or greater on the 3-item OAB Awareness Tool (OABV3), or
    2. High rates of urinary frequency (>13x/day and/or >4x/night).
  11. Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study i.e. unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months, or peripheral arterial disease with intermittent claudication or Leriche's syndrome.
  12. Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant.
  13. Unwilling to use contraception for 3 months following administration of study medication or with an interest in future fertility.
  14. A prolonged QTcF interval at baseline and/or who are currently taking medication that prolongs QT interval ("prolonged QTcF interval" defined as > 450 ms).
  15. Known sensitivity to porphyrin-type drugs or known history of porphyria.
  16. Any contraindications to use of the study treatment.
  17. Active alcohol or drug abuse.
  18. Subject has clinical laboratory test results outside the reference ranges of the testing laboratory that are deemed to be clinically significant. Subjects with isolated test results that are outside the specified ranges and that are assessed as clinically insignificant will be allowed at the discretion of the Investigator, after discussion with the Sponsor's Medical Monitor/Study Physician, if appropriate. If a subject has 1 isolated test result outside the specific range that is deemed potentially clinically significant, rescreening may be allowed at the discretion of the Investigator, after discussion with the Medical Monitor/Study Physician
  19. Subjects with known disorders of coagulation, apart from those receiving anticoagulant / antithrombotic / antiplatelet therapy in whom the dose of such medication must have been stable for at least 1 month prior to randomisation. In those receiving Vitamin K antagonists (warfarin, acenocoumarol, phenindione, etc) the INR value at Screening should be <3.0.
  20. Inability or unwillingness to comply with the required photosensitivity precautions during the three weeks following study treatment.
  21. Subjects taking medications with a recognised propensity for causing photosensitivity (such as amiodarone, tetracyclines, sulphonamides) that cannot be discontinued for the initial study period, namely from 14 days prior to administration of study medication until 28 days afterwards.
  22. Subjects with medical or investigation results deemed unfit for study treatment, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator's opinion, preclude entry into the study.
  23. Subjects who have received an investigational medicinal product within 30 days or 5 half-lives of the investigational product prior to study entry (defined as the start of the Screening Period).
  24. Subjects who are incapable of giving informed consent or complying with the protocol.
Open or close this module Contacts/Locations
Central Contact Person: Maggie Wilson
Email: info@contact-clinical-trials.com
Central Contact Backup: Sally Rooney
Email: info@contact-clinical-trials.com
Study Officials: Sally Rooney
Study Chair
Mundipharma Research Ltd
Locations: United States, Alaska
[Recruiting]
Anchorage, Alaska, United States, 99503
United States, Florida
[Recruiting]
Pompano Beach, Florida, United States, 33060
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
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