A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
Condition: Sialorrhoea
MeSH terms: Sialorrhea; Parkinson Disease
Intervention: oxybutynin and clonidine oral solution treatment A; oxybutynin and clonidine oral solution treatment B; oxybutynin and clonidine oral solution treatment C; oxybutynin and clonidine oral solution treatment D
Intervention description: Placebo
Intervention MeSH terms: Mandelic Acids; Clonidine; Pharmaceutical Solutions; Oxybutynin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: oxybutynin; clonidine; OC Oral Solution; sialorrhoea; Parkinson's disease

Summary:

      The purpose of this study is to determine whether OC (oxybutynin and clonidine) oral solution
      is effective in reducing saliva secretion in patients suffering from Parkinson's Disease with
      excessive salivation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Parkinson's Disease for at least 2 years

          -  Patients with a score of ≥2 on the salivation section of UPDRS, item 6

          -  Patients Hoehn and Yahr stage must be ≤4

          -  under stable anti-Parkinson therapy throughout the study

          -  Able and willing to comply with the study procedures

          -  Able to provide and provision of a written informed consent

        Exclusion Criteria:

          -  Female who is pregnant/lactating or planning to be pregnant

          -  Must not have a form of drug-induced or atypical parkinsonism or parkinsonism with
             swallow problems due to other etiology

          -  Have current uncontrolled hypertension, symptomatic postural hypotension, active
             Raynaud's disease or other peripheral vascular occlusive disease

          -  Have a history or presence of hyperthyroidism, congestive heart failure, coronary
             heart disease, cardiac arrhythmias, tachycardia or severe bradycardia resulting from
             either sick sinus syndrome or AV block of 2nd or 3rd degree

          -  Have a history of narrow angle glaucoma or shallow anterior chamber

          -  Have a history or presence of gastrointestinal obstruction, including paralytic ileus
             and intestinal atony or gastrointestinal motility disorders, toxic megacolon or severe
             ulcerative colitis

          -  Have a history or presence of bladder outflow obstruction or urinary retention

          -  Patients with hepatic or renal impairment

          -  Male with QTc > 430 ms or female with QTc > 450 ms ECG results at screening

          -  Concomitant use of α2-agonist, anticholinergic medication or other medications that
             affect ACh levels

          -  Have a history of alcohol or substance abuse

          -  Any condition, including the presence of laboratory abnormalities, which places the
             patient at unacceptable risk to participate in the study or confounds the ability to
             interpret data from the study

          -  Have a history of hypersensitivity to the investigational medicinal product or any of
             the excipients or to medicinal products with similar chemical structures

          -  Have received treatment with any other investigational medicinal product in the last 6
             weeks before administration of the first dose in this clinical study

          -  Have received treatment with any medicinal product known to have a well-defined
             potential for toxicity to a major organ in the previous 3 months

          -  Have a positive result of the human immunodeficiency virus (HIV) 1 and 2 test

          -  Have problems to understand the protocol requirements, instructions and study related
             restrictions, the nature, scope and possible consequences of the clinical study

          -  Are unlikely to comply with the protocol requirements, instructions and study related
             restrictions

          -  Patient is the Investigator or any sub-investigator, research assistant, pharmacist,
             study coordinator, other staff or relative thereof directly involved in the conduct of
             the clinical study

          -  Vulnerable subjects

          -  Have any concurrent disease or condition that, in the opinion of the Investigator,
             would make the patient unsuitable for participation in the clinical study

          -  Donation of 500 ml or more of blood within the last 8 weeks before start of the study
             and for at least 4 weeks after study completion

          -  Have previously been enrolled in this clinical study

          -  Vulnerable subjects