Randomized Cross-Over Study of Fesoterodine on Urgency Episodes in Parkinson's Disease Population

NCT02385500 Phase 4 TERMINATED

Parkinson's disease (PD) causes several non-motor autonomic symptoms including lower urinary tract dysfunction. Their symptoms can be managed with antimuscarinics with variable efficacy. Fesoterodine offers a new therapeutic molecule to target the symptoms of urinary frequency, urgency and nocturia in this patient population. The purpose of this protocol is to compare the impact of fesoterodine to placebo on urinary urgency and nocturnal sleep problems in a heterogeneous population of PD patients in a cross-over fashion. A representative number of patients with baseline overactive bladder (OAB) symptoms and Parkinson's disease will be recruited to receive either the active drug or placebo for the first phase of eight weeks. The groups will then be crossed-over during the second phase of eight weeks. The main outcomes assessed will be the urgency episodes on a 3-day voiding diary, as well as the nocturnal sleep problems will be the Parkinson's Disease Sleep Scale (PDSS).

Details

Lead sponsor	Sir Mortimer B. Davis - Jewish General Hospital
Phase	Phase 4
Status	TERMINATED
Enrolment	5
Start date	2016-09
Completion	2019-06-07

Conditions

• Urinary Bladder, Overactive
• Parkinson Disease

Interventions

• Fesoterodine
• Placebo

Primary outcomes

• Urgency episodes — 10 weeks and 20 weeks
  Mean change from baseline in number of urgency episodes per 24 hours

Countries

Canada