E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ortostatic hypotension in patients with Parkinsons disease |
Ortostatisk hypotension hos patienter med parkinsons sygdom |
|
E.1.1.1 | Medical condition in easily understood language |
Ortostatic hypotension in patients with Parkinsons disease |
Ortostatisk hypotension hos patienter med parkinsons sygdom |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031127 |
E.1.2 | Term | Orthostatic hypotension |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- 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 |
• At undersøge det blodtryksregulerende nervesystems funktion hos patienter med Parkinsons sygdom og ortostatisk hypotension før og efter behandling med pyridostigmin (Mestinon®).
• At undersøge virkningen af forskellige doseringer af pyridostigmin (Mestinon®) hos patienter med Parkinsons sygdom og ortostatisk hypotension.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Idiopatic parkinsons disease
- 18 y ≤ age ≤ 80 y
- Orthostatic hypotension
- Self-reliable
- Fertile women must use contraceptives |
• Idiopatisk Parkinsons sygdom i minimum 5 år.
• 18 år ≤ alder ≤ 80 år
• Ortostatisk hypotension
• Selvhjulpne eventuelt med hjælpemidler
• Kvinder i den fødedygtige alder skal bruge sikker prevæntion
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|
E.4 | Principal 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
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• Gravide eller ammende
• Manglende evne til at samarbejde
• Parkinson Plus sygdomme
• Hjerterytme forstyrrelser (undtagen 1. og 2. grad AV-blok)
• Klinisk hjerteinsufficiens
• Diabetes mellitus
• Nedsat nyrefunktion
• Svær anæmi (mere end 10 % under nedre normalgrænse)
• Stofskiftelidelser
• Anden cerebrovaskulær sygdom
• Behandling med anticholinergika, vasoaktiv medicin eller anden medicin som vil kunne påvirke det autonome nervesystems funktion
• Anden sygdom som vides at kunne påvirke det autonome nervesystem
• Mekanisk obstruktion i gastro-intestinalkanalen eller urinvejene
• Peritonitis
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes in systolic (SBP) and diastolic (DBP) blood pressure at baseline and 3 min with 60 degrees head-up tilt |
Ændring af systolisk (SBP) og diastolisk (DBP) blodtryk ved baseline og tid 3 minutter ved 60 graders head-up tilt |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Othostatic symptoms
- Symptoms during 24 hours blood pressure monitoring |
• Ortostatiske symptomer
• Symptomer under 24 timers døgn-blodtryks monitorering
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|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
6,9,12 og 15 min
24 hours |
6,9,12 og 15 min
24 timer |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |