Clinical Studies

Interstitial Cystitis Study

Women and Men Needed to Participate in a Clinical Research Study of an Oral Investigational Drug for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).  
Research Study Title: The LEADERSHIP 301 Trial: A 12-Week, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by an Extension Period.

Sponsor: Aquinox Pharmaceuticals (Canada) Inc.

Purpose: The purpose of the LEADERSHIP 301 Trial is to evaluate if an investigational drug, AQX-1125, reduces the bladder pain that comes with interstitial cystitis/bladder pain syndrome (IC/BPS) or relieves other symptoms such as urinary frequency. The study drug is a new type of medication that may help reduce inflammation and pain in the bladder.

An earlier clinical study in women with IC/BPS showed that those who took the study drug every day for 6 weeks experienced reduced bladder pain and improved symptoms compared to those who took placebo.1

Eligibility: You may qualify if you:

  • Are male or female between the ages of 18 and 80 years

  • Have been diagnosed with IC/BPS for more than 3 months but not more than 20 years

  • Have consistently experienced moderate to severe bladder pain, urinary urgency, and/or urinary frequency

What Will Happen During the Study: As a study participant, you will have regular contact with our study team who will monitor your health closely. There will be 13-14 visits during the study which will last 22 months:   
  • 12-week, double-blind treatment period (2 in 3 chance of receiving study drug)
  • 52-week extension study period during which all participants will receive active study drug
  • Final follow-up visit 6 months after the last dose of study medication

For Additional Study Information: 

1. Nickel JC, et al. A Phase II study of the efficacy and safety of the novel oral SHIP1 activator AQX-1125 in subjects with moderate to severe interstitial cystitis/bladder pain syndrome. J Urol. 2016;196(3):747-754.

Temporomandibular Disorders Studies

Patients Needed in Baltimore MD Area: Biobehavioral Pain Management in TMD Research Study

Researchers at Johns Hopkins School of Medicine and the University of Maryland Dental School are looking for volunteers with widespread pain that includes jaw pain (TMD) to participate in a research study to investigate the effect of three different non-drug treatments on pain and sleep symptoms. If you have fibromyalgia and jaw pain you may be eligible. For additional information, please read through the study information brochure and patient consent form.  


Patients Needed in Baltimore MD Area: Study on Genetics and Facial, Jaw and Headache Pain

Researchers at the University of Maryland School of Nursing asked us to post the following announcement on a research opportunity for patients.

Chronic orofacial pain represents an economic burden both in the United States and worldwide affecting 5-10% of the population. Researchers at the University of Maryland, Baltimore have developed a novel and comprehensive genetic, behavioral and imaging approach to study the role of genetic variations on pain mechanisms in healthy participants as well as participants with facial, jaw and headache pain.

Who is eligible to participate?

You may qualify if you:

  • Are 18-65 years of age.
  • Speak and understand English.
  • Are either in good health, or you have had recent headaches, facial pain, and/or jaw pain.

This research study requires:

  •  One screening visit for ensuring eligibility.
  •  One experimental study session lasting no more than four hours.

Compensation for all sessions and parking vouchers are provided. If you are interested, please email or call 410-706-5975

For more information, please read the informational flyer.


Comparative Study of Women Considering or Currently Receiving Botox© Injections for TMJ Pain

Are you a woman within the Los Angeles or New York City areas with TMJ pain in facial muscles, who has either:

a. recently had Botox© injections for your pain or

b. not had Botox© for your pain but has thought about such treatment?

If either is true for you, you may qualify for an observational research study centrally administered by the New York University College of Dentistry. It is funded by the National Institutes of Health (NIH). The purpose of this study is to understand potential health risks that may be caused by treating "TMJ pain" with Botox© injections. Potentially eligible women must first complete a brief interview via telephone to confirm eligibility. Click here for further study information and details.   



Chronic Pain Study

Maternal Chronic Pain Study   
A high proportion of women with children experience chronic pain conditions such as temporomandibular disorders, low back pain, headache, and fibromyalgia. Parenting with chronic pain is a unique challenge that many parents face. Oregon Health & Science University , Stanford, and Seattle Children's Hospital are conducting a study to learn more about the impact of maternal chronic pain in hopes of helping mothers and families in the future. 

This study might be a good fit for you if:
  • You are a mother who has had chronic pain for 6 months or longer
  • You have a child between the ages of 8 and 12 years old

 Participants will complete online questionnaires and electronic diaries. Compensation is provided.

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