An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects with Overactive Bladder (OAB)

Solifenacin succinate as tablet formulation is a registered medicine developed
for the treatment of symptoms of overactive bladder in adults. For the use in
children and adolescent patients a new formulation of solifenacin has been
developed. The new formulation is a liquid that will be taken by mouth. In this
study, evidence will be collected for the efficacy and safety of Solifenacin
succinate suspension. (Section 1.1 of Protocol versie 29Sep2011).

To evaluate the safety and efficacy of solifenacin succinate suspension once
daily in children and adolescents with OAB.

An open-label, long-term extension, multi-center, sequential dose titration
study. This is a multiple dose safety extension study.

In this study all patients will receive the active study drug solifenacin
suspension and no patients will get placebo anymore. The study commences with a
titration phase of up to 12 weeks during which the subject*s dose can be up or
down titrated based on a combination of efficacy and safety parameters followed
by a fixed dose phase during which no dose adjustments are allowed. All
patients will be given a starting dose of the solifenacin suspension which is
equivalent to the 5 mg tablets in adults, except for patients who finished
study 905-CL-076 with the equivalent of 2.5 mg in adults. These patients can
start with a pediatric equivalent dose of 2.5mg in this extension study. The
dose can be increased or decreased to 2.5, 7.5 or 10 mg until the most suitable
dose is found for your son*s/daughter*s symptoms and their response to the
study medication. The study drug will be given via a syringe directly into the
mouth, with a glass of water afterwards.
The exact volume of suspension your son/daughter receives will dependent on
his/her weight at visit 8 and will be assigned according to the weight range,
into which his/her weight fits. The exact volume for the child will be written
on the bottles. The study medication has to be taken every morning with a glass
of water.
To ensure that subjects who do not require drug therapy will be discontinued
from the study during the titration phase, down titration to *no
treatment* (i.e. interruption of treatment for 3 weeks) can be performed
following a sustained complete response after 3 weeks of treatment with PED2.5.

Please refer to 'Section 7. Which side-effects and risks can your child
expect?' and 'Addendum V. Side Effects' in the patient information for the
parents.
The most common side effects and discomforts of solifenacin succinate are: dry
mouth, constipation, blurred vision, indigestion, abdominal pain and nausia.
When the patient or his partner becomes pregnant, this may have effect for the
unborn child.
In addition, the patient could have discomfort from the following procedures:
Blood tests: Blood will be taken from a needle. The patient may experience
minor discomfort from these procedures, and occasionally some bruising or
irritation of the veins used for blood sampling. These effects normally clear
up completely in a few days. Every effort will be made to reduce the anxiety
felt by some patients e.g. during a blood test. Local anesthetic cream can be
used to help numb any pain.
ECG: Slight skin irritation from the ECG electrodes can occur, but this is
generally mild and clears up within a few days.