Sialorrhoea associated with Parkinson's Disease MedDRA version: 9.1 Level: LLT Classification code 10059812 Term: Sialorrhoea
Conditions
Interventions
Trade Name: Catapres ampoules
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Clonidine hydrochloride
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Conce
Sponsors
Summit (Cambridge) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether adding oxybutynin to a dose of clonidine that has a demonstrable inhibitory effect on saliva secretion rates produces an additional inhibitory effect. ;Secondary Objective: • To determine the dose-response relationship for clonidine and saliva secretion rates in Parkinson’s disease patients. • To determine the dose-response relationship for a fixed dose of clonidine in combination with a range of doses of oxybutynin and saliva excretion rates in Parkinson’s disease patients. • To determine the ratio of oxybutynin:clonidine doses that produce the maximum inhibitory effect on saliva secretion rates. • To evaluate the safety profile of clonidine alone and in combination with oxybutynin in PD patients. • To determine the PK profile of clonidine alone, and of clonidine and oxybutynin when these drugs are co-administered, in PD patients.;Primary end point(s): - Saliva excretion rates as determined by Saxon tests - Vital signs (lying and standing blood pressure and heart rate). - Continuously monitored blood pressure and heart rate | — |
Countries
United Kingdom
Outcome results
None listed