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To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis.
This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of two dosing regimens of MN-001 in patients with Interstitial Cystitis (IC). Patients will be screened for study eligibility within seven to nine days of randomization. Eligible patients will be randomized in a 1:1:1 ratio to receive either 500 mg MN-001 bid, 500 mg MN-001 once daily or placebo. Patients will be dispensed study drug beginning at Baseline (Visit 2) and will return to the study center for Visit 3 (28 days ± 2 days after Baseline), and Visit 4 (56 days ± 2 days after Baseline), at end of study for safety and efficacy assessments. The patient will be contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. Study drug will be dispensed at Visits 2 and 3. Safety assessments will include adverse events, physical examinations, clinical laboratory testing, and changes in vital signs. Efficacy assessments include percentage of patients at least "moderately improved" for each treatment group using the patient reported Global Response Assessment (GRA) (see Appendix 1). Secondary assessments include a decrease in bladder pain/urgency based on change in the patient rating from baseline to endpoint using the GRA (see Appendix 1), modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale (see Appendix 2) and the O'Leary Sant IC Symptom and Problem Index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MN-001 | Experimental |
| |
| MN-001 once daily | Placebo Comparator | placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MN-001 BID | Drug | Eligible patients received 500 mg MN-001 bid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA) | The primary endpoint was the GRA overall change "in their condition" at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders for GRA Assessment in Their Condition at Week 4. | Responders were defined as patients who were 'moderately improved' or 'markedly improved' and non-responders were defined as patients who were 'markedly worse', 'moderately worse', 'mildly worse', no change, or 'mildly improved' on the GRA assessments. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard E Gammans, MD | MediciNova, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MediciNova Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| Citrus Valley Urological Medical Group |
Eligible patients were randomized in a 1:1:1 ratio to receive 500 mg MN-001 twice daily (BID), 500 mg MN-001 once daily (QD), or placebo. Patients returned to the study center at Visit 3 (Day 28) and at Visit 4 (Week 8, Day 64) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3.
Patients were screened for study eligibility within 7-9 days of randomization. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments prior to randomization at Visit 2 (Baseline Visit, Day 0).
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| ID | Title | Description |
|---|---|---|
| FG000 | MN-001 500 mg qd | This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MN-001 |
| Drug |
Eligible patients received 500 mg MN-001 once daily (qd) |
|
| Placebo | Drug | Eligible patients received placebo |
|
| Glendora |
| California |
| 91741 |
| United States |
| Atlantic Urological Medical Group | Long Beach | California | 90806 | United States |
| Mendez Transplant and Urological Medical Group | San Diego | California | 92103 | United States |
| Boulder Medical Center, P.C. | Boulder | Colorado | 80304 | United States |
| Western Urologic Research Center | Wheat Ridge | Colorado | 80033 | United States |
| Segal Institute for Clinical Research | Aventura | Florida | 33180 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33437 | United States |
| West Florida Urology | Palm Harbor | Florida | 34684 | United States |
| Adult and Pediatric Urology | Plantation | Florida | 33317 | United States |
| Georgis Patsias, MD., PA | Wellington | Florida | 33414 | United States |
| Shepherd Center, Inc. | Atlanta | Georgia | 30309 | United States |
| Center For Advanced Pelvic Surgery | Centralia | Illinois | 62801 | United States |
| Evanston Continence Center | Evanston | Illinois | 60201 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Sheldon J. Freedman, MD, LTD | Las Vegas | Nevada | 89109 | United States |
| Associated Urologic Specialists, P.A. | Marlton | New Jersey | 08053 | United States |
| Upstate Urology | Albany | New York | 12206 | United States |
| Lyndhurst Gynecology Associates | Winston-Salem | North Carolina | 27103 | United States |
| Tristate Urologic Services PSC., Inc. | Cincinnati | Ohio | 45212 | United States |
| Midwest Regional Center For Chronic Pelvic Pain and Bladder Control | Lima | Ohio | 45805 | United States |
| Williamette Women's Healthcare P.C. | Tualatin | Oregon | 97062 | United States |
| The Urology Group | Greer | South Carolina | 29650 | United States |
| Medical Arts Clinic | Corsicana | Texas | 75110 | United States |
| Gant Foundation | Fort Worth | Texas | 76104 | United States |
| Brian Heaton, MD | Ogden | Utah | 84403 | United States |
| Integrity Medical Research, LLC | Mountlake Terrace | Washington | 98043 | United States |
| FG001 | MN-001 500 mg BID | Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. |
| FG002 | Placebo | Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. |
| Safety Population (N=304) |
|
| ITT Population (N=296) |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MN-001 500 mg qd | This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. |
| BG001 | MN-001 500 mg BID | Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. |
| BG002 | Placebo | Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| diagnosis of moderate to severe interstitial cystitis (IC) with bladder pain for ≥ 6 months | Diagnosis of moderate to severe interstitial cystitis (IC) with bladder pain for ≥ 6 months prior to Baseline, a score of ≥ 15 on the Modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale, a score of ≥ 12 on the O'Leary Sant IC Symptom and Problem Index, urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake, and a history of nocturia ≥ 2 x/night over an 8-hour period prior to screening or Baseline. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Responders for GRA Assessment in Their Condition at Week 4. | Responders were defined as patients who were 'moderately improved' or 'markedly improved' and non-responders were defined as patients who were 'markedly worse', 'moderately worse', 'mildly worse', no change, or 'mildly improved' on the GRA assessments. | Posted | Number | participants | 4 weeks |
|
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| |||||||||||||||||||||||||||||||||
| Primary | Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA) | The primary endpoint was the GRA overall change "in their condition" at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved. | Posted | Number | participants | 8 weeks |
|
The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo.
Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MN-001 500 mg qd | This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. | 1 | 92 | 48 | 92 | ||
| EG001 | MN-001 500 mg BID | Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. | 0 | 105 | 65 | 105 | ||
| EG002 | Placebo | Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. | 1 | 99 | 28 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (7.1) | Non-systematic Assessment | 22 y.o. patient notified site of pregnancy.Female infant reported to have a severe coloboma of retina, iris.Event was continuing at the time of report.No further information available. P.I. opinion: event was possibly related to the study medication. |
|
| infected epidermal cyst | Skin and subcutaneous tissue disorders | MedDRA (7.1) | Non-systematic Assessment | 56 y.o. female,epidermal cyst of R thigh,incision,drainage.Hospitalized for worsening cellulitis and had repeat incision,drainage,excision of the cyst, treated with ABs. Recovered from SAE 2 mo later.TEAE considered possibly related to study drug. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Loose stools | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Interstitial Cystitis | Renal and urinary disorders | MedDRA (7.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard E. Gammans PhD Chief Developing Officer | Medicinova Inc | 848-373-1500 | gammans@medicinova.com |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C526359 | 4-(6-acetyl-3-(3-(4-acetyl-3-hydroxy-2-propylphenylthio)propoxy)-2-propylphenoxy)butyric acid |
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| Male |
|
| Over 18 years old |
|
| OG002 | Placebo | Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. |
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