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Small Molecule

AQX-1125 100 mg for Interstitial Cystitis (LEADERSHIP 301 Trial)

Phase 3
Waitlist Available
Led By Robert Moldwin, MD
Research Sponsored by Aquinox Pharmaceuticals (Canada) Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12-weeks; during 52-week ep and baseline to 64-weeks, with a 4-week post-dose, and 6 month post-dose (ocular only), follow-up
Awards & highlights

LEADERSHIP 301 Trial Summary

This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome. Participants will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of the study. After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1125 for 52 weeks.

Eligible Conditions
  • Interstitial Cystitis

LEADERSHIP 301 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12-weeks; during 52-week ep and baseline to 64-weeks, with a 4-week post-dose, and 6 month post-dose (ocular only), follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12-weeks; during 52-week ep and baseline to 64-weeks, with a 4-week post-dose, and 6 month post-dose (ocular only), follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Maximum Daily Bladder Pain Score
Secondary outcome measures
Change from Baseline Interstitial Cystitis Symptom Index Score
Change from Baseline in Bladder Pain/Interstitial Cystitis Symptom Score
Change from Baseline in Subject's Global Response Assessment
+1 more
Other outcome measures
Frequency and Severity of Adverse Events

LEADERSHIP 301 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: AQX-1125 200 mgExperimental Treatment1 Intervention
2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period
Group II: AQX-1125 100 mgExperimental Treatment1 Intervention
2 tablets, by mouth, once per day for 12 weeks; followed by a 52-week Extension Period
Group III: PlaceboPlacebo Group1 Intervention
2 placebo tablets, by mouth, once per day for 12 weeks; followed by randomization to 100 mg or 200 mg AQX-1125 for a 52-week Extension Period

Find a Location

Who is running the clinical trial?

Aquinox Pharmaceuticals (Canada) Inc.Lead Sponsor
6 Previous Clinical Trials
567 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
69 Patients Enrolled for Interstitial Cystitis
Robert Moldwin, MDPrincipal InvestigatorHofstra Northwell School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome
2016. "Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02858453.
All > Interstitial Cystitis
~49 spots leftby Apr 2025
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