Improving the blood pressure regulating system in patients with parkinsons disease

Acethylcholineesterase inhibition and orthostatic hypotension in patients with parkinsons disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000122-21-DK

Enrollment

Registered

2012-06-07

Start date

2012-08-10

Completion date

Unknown

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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;Secondary Objective: ;Primary end point(s): Changes in systolic (SBP) and diastolic (DBP) blood pressure at baseline and 3 min with 60 degrees head-up tilt;Timepoint(s) of evaluation of this end point: 3 min	—

Measure

Time frame

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;Secondary Objective: ;Primary end point(s): Changes in systolic (SBP) and diastolic (DBP) blood pressure at baseline and 3 min with 60 degrees head-up tilt;Timepoint(s) of evaluation of this end point: 3 min

—

Secondary

Measure	Time frame
Secondary end point(s): - Othostatic symptoms - Symptoms during 24 hours blood pressure monitoring;Timepoint(s) of evaluation of this end point: 6,9,12 og 15 min 24 hours	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026