Official Title: “URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease”

This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: solifenacin succinate (VESIcare)
  • up to 10mg every day orally
• Drug: placebo
  • placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: solifenacin succinate (VESIcare)
• Placebo Comparator: placebo

Primary Measures

• The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity
  • Time Frame: 12 weeks
    Safety Issue?: No
• To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity
  • Time Frame: 12 weeks
    Safety Issue?: No
• To examine the effect of solifenacin succinate (VESIcare) on quality of life
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain
• Bank Clinical Diagnosis Criteria.
• 2. Age 50 years to 80 years.
• 3. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
• 4. Patients must score 1.0 to 3.0 on the Modified Hoehn and Yahr scale.
• 5. Women of child-bearing potential must use a reliable method of contraception.
• 6. Must be experiencing symptoms of overactive bladder according to the ICS definition of a minimum voiding 8 or more times/24 hours and a daily average of at least 1 episode of urgency and/or urinary incontinence (urge incontinence predominately as measured by 3IQ diary) per 24 hours during a 3-day micturition diary period. Patients must have documentation of OAB within the last 6 months.
• 7. The patient must have evidence of PSA less than or equal to 4 (males only) within the last 12 months (obtained from primary care physician).
• 8. The patient must have had a bladder scan within six months of the screening visit.
• This scan uses ultrasound technology to measure residual fluid levels in the bladder after urination. This scan must document post void residual of 200 mls or less. A bladder scan printout or a note documenting these findings must be provided before baseline.
• 9. Clearance from the patient's internist or primary care health provider who has examined the patient within the last 6 months.

Exclusion Criteria:

• 1. Any illness that in the investigator's opinion preclude participation in this study.
• 2. Pregnancy or lactation.
• 3. Concurrent participation in another clinical study.
• 4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam scores less than 27).
• 5. Legal incapacity or limited legal capacity.
• 6. History of prostate cancer or Transurethral resection of the prostate (TURP) (males only).
• 7. Presence of severe renal disease. BUN 50% greater than normal (normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d
• L). Labs within the past 12 months will be requested from the patient's health care provider or urologist. If labs are not available within this time-frame or if results are abnormal, labs will be obtained as part of the screening visit.
• 8. Presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, Wilson's disease, or Hemochromotosis).
• 9. Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor such as itraconazole, ritonavir, nelfinavir, clarithromycin, or nefazadone.
• 10. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
• 11. History of narrow angle glaucoma.
• 12. Patients who have undergone pelvic radiation at any time.
• 13. Currently taking any of the following medications:
• Antiarrhythmics: flecainide (Almarytm, Apocard, Ecrinal, Flécaine), digoxin (Lanoxin, Digitek, Lanoxicaps)
• Antipsychotics: thioridazine (Mellaril, Novorizadine, Thioril)
• Tricyclic anti-depressants: amitriptyline (Elavil, Tryptanol, Endep, Elatrol, Tryptizol, Trepiline, Laroxyl), amoxapine (Asendin, Asendis, Defanyl, Demolox, Moxadil), clomipramine (Anafranil), desipramine (Norpramin, Pertofrane), imipramine (Antideprin, Deprenil, Deprimin, Deprinol, Depsonil, Dynaprin, Eupramin, Imipramil, Irmin, Janimine, Melipramin, Surplix, Tofranil), nortriptyline (Aventyl, Pamelor, Nortrilen), protriptyline (Vivactil), trimipramine (Stangyl, Surmontil, Rhotrimine)
• Psychotropics: doxepin (Aponal, Adapine, Sinquan, Sinequan)
• Anticholinergics/Antispasmodics: trihexyphenidyl (Artane, Aparkan), benztropine (Cogentin), oxybutynin (Ditropan, Ditropan XL, Lyrinel XL, Oxytrol), darifenacin (Enablex), emepronium, flavoxate (Urispas), meladrazine, propiverine, solifenacin (Vesicare), tolterodine (Detrol, Detrol LA), trospium (Sanctura)
• Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRI): duloxetine (Cymbalta, Yentreve), Venlafaxine (Effexor, Effexor XR)
• Arylalkylamines: pseudoephedrine (Sudafed)
• Anti-androgen: bicalutamide (Casodex, Cosudex, Calutide, Kalumid), finasteride (Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo, Prosteride, Gefina, Finasterid IVAX), dutasteride (Avodart, Avidart, Avolve, Duagen, Dutas, Dutagen, Duprost), Zoladex (goserelin acetate), Eulexin (flutamide), Lupron (leuprolide acetate)
• Antihypertensives: prazosin (Minipress, Vasoflex, Hypovase)
• Estrogens (Menest, Premarin, Premarin IV)
• Acetylcholinesterase inhibitors (rivastigmine (Exelon), galantamine, (Reminyl, donepezil (Aricept), Tacrine.
• Memantine (Namenda)
• 14. Urinary obstruction in male PD patients as diagnosed by a urologist
• 15. Active urinary tract infection.
• 16. Patients with a history of chronic severe constipation (by self report)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of South Florida

Overall Clinical Trial Officials and Contacts

Theresa Zesiewicz, MD Principal Investigator University of South Florida  

Overall Contact: Kelly Sullivan, MSPH 813-974-5909 kbarber@health.usf.edu

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018264

Study ID Number: Sullivan-9

ClinicalTrials.gov Identifier: NCT01018264

Health Authority: United States: Institutional Review Board