A study for children (6–17 years old) with neurological bladder problems

New research beginning Fall 2015

This research project has been extended into the Fall 2015 with new ages and weights. Check back late summer 2015.

If your child is 6 to 17 years old, weighs more than 25 kg (55 lbs), and has overactive bladder problems due to a nervous system condition (such as spina bifida), then he or she might be interested in participating in a clinical research trial for young people with neurogenic overactive bladder. This is medically known as “Neurogenic Detrusor Overactivity” or “NDO.”

This condition can sometimes result in:

• Difficulty staying dry during the day or night
• Feeling a sudden and unexpected need to pass urine immediately (urgency)
• Having to pass a tube into the bladder to empty it properly (also known as catheterization)

Click here to view an active center in your area

What is NDO?
NDO is a urinary condition where the bladder does not work properly, causing problems with emptying and leakage. This can sometimes occur in conditions such as spina bifida and cerebral palsy, or if there is damage to the spinal cord.

What are some of the long term effects of NDO?
Children with NDO are more likely to experience infections of the bladder (urinary tract infections), and may also be at increased risk of developing kidney damage with time. Some children may also experience difficulty having regular bowel movements (constipation) or be at greater risk of developing bladder stones.

What kind of help is there for people with NDO?
There are several treatments available for people with NDO. These may include:

• Using a tube (catheter) to help empty the bladder
• Taking medications by mouth or in the bladder to help manage some of the symptoms
• Antibiotics to help prevent or treat a urinary tract infection
• Surgery

Does your child have bladder problems caused by a nervous system condition (such as spina bifida)?
Doctors are currently conducting a clinical research study to see if the study drug can help children aged 6 to 17 years old. Your child may be eligible to take part in this research. To find out what is involved, please read on…

What is a clinical study?
A clinical study is a scientific study to see how new or existing medications work in people. Before a study drug can be made available, clinical studies have to be carried out to see if the study drug is safe and effective.

What is the point of this particular clinical study?
The purpose of this clinical study is to learn more about the effects of the study drug on the number of wetting episodes, catheterizations or frequency of passing urine, and bladder function, as well as the side effects in young people aged 6 to 17 years old with NDO.

What are the benefits of joining a clinical study?
Qualified study participants receive study related medical care and attention from study doctors and nurses. The study may not benefit your child directly, but the information gathered may be of help to other individuals in the future with the same condition.

What would your child need to do if he/she qualifies for the clinical study?
The study lasts for 26 weeks. Your child would visit the clinic at least five times and receive at least 4 additional contacts from the study team. During the visits, the study doctor would talk to your child about how he/she is feeling, carry out some general health checks and take some blood and urine samples. He/She will also be asked to complete a test which will involve putting pegs into a board as well as have some tests on their heart and bladder.

On two occasions during the study, your child will also be asked to complete a bladder diary for 3 days to collect information about their bladder symptoms. In addition, you will be asked to complete a questionnaire related to your child’s behavior.

During the study, your child will receive study drug to take every day for about 24 weeks. Your child and the study doctor will know exactly what your child is taking at all times. He/she will also be asked to complete a dosing log every day. After the study, your child’s NDO will continue to be treated in the manner most suitable for their condition.

Are there risks of joining a clinical study?
The study drug is not currently approved to treat NDO in children. Therefore, the use of the study drug in children aged 6 to 17 years old is investigational. All medications have side effects. The study doctor will explain the side effects of the study drug to you and your child.

What if your child wants to leave the study?
Your child can leave the study at any time without giving a reason. If your child does choose to do this, you are asked to tell the study doctor.

What will it cost to join the study?
Nothing. It will not cost anything to join the study. You or your child may be reimbursed for any travel or study related expenses that you incur, if appropriate.

What do I do next?
If you and your child are interested in learning more about NDO or what is involved in clinical study participation, please click on the link for your region at the bottom of this page.

There is absolutely no pressure on you at all for your child to take part in this clinical study. It is entirely up to you and your child.

About Parexel International
We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, integrated eClinical technologies, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end. Headquartered near Boston, Massachusetts, PAREXEL International operates in 76 locations with more than 15,000 employees in 50 countries worldwide.