A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients

• Conditions: Sialorrhoea associated with Parkinson's Disease; MedDRA version: 9.1Level: LLTClassification code 10059812Term: Sialorrhoea

• Registration Number: EUCTR2007-004654-81-GB
• Lead Sponsor: Summit (Cambridge) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The patient has Parkinson’s disease, with a score of >2 on the salivation section of
UPDRS.
2. The patients’ anti-Parkinsonian medication is anticipated to remain constant (in terms of drugs, doses and timing) throughout the study period.
3. The patient is aged 18 to 75 years.
4. The patient is capable of giving informed consent and complying with the restrictions and requirements of the protocol.
5. The patient is available to complete the study.
6. The patient is registered with a General Practitioner (GP).
7. A signed and dated consent form has been obtained from the patient in accordance with ICH GCP.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. As a result of the medical screening process, the study physician considers the patient unfit for the study.
2. The patient is taking anticholinergic or a2 agonist medication.
3. The patient is taking medication that affects acetyl choline levels e.g. tricyclic
antidepressants.
4. The patient has a history or presence of bladder outflow obstruction.
5. The patient has a hypersensitivity to oxybutynin or any component.
6. The patient has a hypersensitivity to clonidine hydrochloride or any component.
7. The patient has a history or presence of Myasthenia gravis.
8. The patient has a history of narrow angle glaucoma or shallow anterior chamber.
9. The patient has a history or presence of gastrointestinal obstruction including paralytic ileus and intestinal atony or gastrointestinal motility disorders.
10. The patient has a history or presence of toxic megacolon or severe ulcerative colitis.
11. The patient has documented autonomic neuropathy, hepatic or renal impairment,
12. The patient has presence of any clinically significant abnormality, in the opinion of the Investigator, on ECGs (including patients with baseline QTc > 430 msecs - males, > 450 msecs female) at screening.
13. The patient has a history or presence of severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree.
14. The patient has a history or presence of hyperthyroidism, congestive heart failure, coronary heart disease, cardiac arrhythmias, tachycardia, current uncontrolled
hypertension, significant postural hypotension or urinary retention.
15. The patient has current active depression, Raynaud’s disease or other peripheral
vascular occlusive disease.
16. The patient has a history of drug or other allergy that contraindicates his/her
participation.
17. The patient has participated in a study with a new molecular entity within 4 months, or any other drug trial within 3 months of dosing with the investigational product or placebo.
18. The patient has donated a unit of blood (450 mL) in the 3 months prior to dosing or intends to donate in the month after the last scheduled study visit.
19. The subject has a history of drug abuse.
20. The patient, if a pre menopausal female, is pregnant or at risk of becoming pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified