Improving the blood pressure regulating system in patients with parkinsons disease

• Register: EUCTR
• Last refreshed on: 19 March 2018
• Main ID: EUCTR2012-000122-21-DK
• Date of registration: 07/06/2012
• Prospective Registration: Yes
• Primary sponsor: Department of Neurology, Roskilde Hospital
• Public title: Improving the blood pressure regulating system in patients with parkinsons disease
• Scientific title: Acethylcholineesterase inhibition and orthostatic hypotension in patients with parkinsons disease
• Date of first enrolment: 10/08/2012
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000122-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: yes; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

Inclusion criteria:
- Idiopatic parkinsons disease
- 18 y = age = 80 y
- Orthostatic hypotension
- Self-reliable
- Fertile women must use contraceptives
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
- pregnant or nursing
- non-compliance
- Parkinson Plus diseases
- Heart rhythm problems (except 1. and 2. AV-block)
- Congestive heart insufficiency
- Diabetes Mellitus
- Reduced Kdney function
- Severe anaemia (lower than 10% under lower limit)
- Metabolic disorders
- Other cerebrovascular disorders
- treatment using anticholinergic, vasoactive or other medication that would affect the autonomic nervous system
- Other diseases that would affect the autonomic nervous system
- Mechanical obstruction of the gastrointestinal tract or urinary tract
- Peritonitis



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ortostatic hypotension in patients with Parkinsons disease
MedDRA version: 14.1 Level: PT Classification code 10031127 Term: Orthostatic hypotension System Organ Class: 10047065 - Vascular disorders

Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Intervention(s)

Trade Name: Mestinon
Product Name: Mestinon
Pharmaceutical Form: Capsule
INN or Proposed INN: PYRIDOSTIGMINE BROMIDE
CAS Number: 101-26-8
Current Sponsor code: SJ-193
Other descriptive name: Mestinon
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 60-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Changes in systolic (SBP) and diastolic (DBP) blood pressure at baseline and 3 min with 60 degrees head-up tilt

Main Objective: - To investigate the blood pressure regulating system in patients with parkinsons disease and ortostatic hypotension before and after treatment with pyridostigmin (mestinon)
- To investigate the effect of two different doses of pyridostigmin (Mestinon) in patients with Parkinsons disease and orthostatic hypotension

Timepoint(s) of evaluation of this end point: 3 min

Secondary Objective:

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 6,9,12 og 15 min
24 hours

Secondary end point(s): - Othostatic symptoms
- Symptoms during 24 hours blood pressure monitoring

Secondary ID(s)

SJ-193