A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease

NCT01370811 | Completed Phase 2 Results

• 1 other identifier: OP-014-201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sialorrhoea

Keywords

oxybutynin; clonidine; OC Oral Solution; sialorrhoea; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Saliva Secreted Rate

  Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion.

  8 hours post-dose

Secondary Outcomes (2)

• Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production

  8 hours post-dose

• Evaluation of the Safety and Tolerability of Different Combinations of Oxybutynin and Clonidine (OC Oral Solution) in Patients Suffering From Parkinson's Disease With Excessive Salivation

  during the study treatment period and follow up period at least 23 days excluding the screening period.

Study Arms (4)

oxybutynin and clonidine oral solution treatment D

PLACEBO COMPARATOR

Placebo

Drug: oxybutynin and clonidine oral solution treatment D

oxybutynin and clonidine oral solution treatment C

EXPERIMENTAL

High dose oxybutynin and clonidine

Drug: oxybutynin and clonidine oral solution treatment C

oxybutynin and clonidine oral solution treatment A

EXPERIMENTAL

Low dose oxybutynin and clonidine

Drug: oxybutynin and clonidine oral solution treatment A

oxybutynin and clonidine oral solution treatment B

EXPERIMENTAL

Intermediate dose oxybutynin and clonidine

Drug: oxybutynin and clonidine oral solution treatment B

Interventions

oxybutynin and clonidine oral solution treatment A DRUG

Also known as: OP-014

oxybutynin and clonidine oral solution treatment A

oxybutynin and clonidine oral solution treatment B DRUG

Also known as: OP-014

oxybutynin and clonidine oral solution treatment B

oxybutynin and clonidine oral solution treatment C DRUG

Also known as: OP-014

oxybutynin and clonidine oral solution treatment C

oxybutynin and clonidine oral solution treatment D DRUG

Placebo

Also known as: Placebo

oxybutynin and clonidine oral solution treatment D

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orient Pharma Co., Ltd.: lead

Study Sites (1)

QUEST Research Institute

Bingham Farms, Michigan, 48025, United States

Location

MeSH Terms

Conditions

Sialorrhea; Parkinson Disease

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

Due to adverse event, one female patient (randomized number R24) did not complete her 4th study treatment (Treatment D/Placebo) in this 4-way cross over study.

Results Point of Contact

• Title: Aaron L. Ellenbogen, OD, MPH
• Organization: Quest Research Institute

aellenbogen@comcast.net

+1 248 644 7770

Study Officials

• Aaron L Ellenbogen, DO, MPH

  QUEST Research Institute

  PRINCIPAL INVESTIGATOR

• Chi-Tai Chang, PhD

  Orient Pharma Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 10, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 10, 2023
• Results First Posted: April 10, 2023

Record last verified: 2023-03

Locations

US (1)