Improving the blood pressure regulating system in patients with parkinsons disease

Phase 1

• Conditions: Ortostatic hypotension in patients with Parkinsons disease; MedDRA version: 14.1Level: PTClassification code 10031127Term: Orthostatic hypotensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2012-000122-21-DK
• Lead Sponsor: Department of Neurology, Roskilde Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-07
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

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