Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -Treatment
Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
Disabling symptoms of blood pressure dysregulation, impaired swallowing and digestion are
common amongst Parkinson's patients. So far the exact pathophysiology for this is not fully
understood. There are results from pathological analyses that the autonomic nervous system is
also affected by the accumulation of alpha-Synuclein and that this might even happen in very
early stages of the disease process (Qualman et al., 1984; Wakabayashi et al., 1989;
Wakabayashi et al., 1990; Bloch et al., 2006).
Blood pressure dysregulation is a common autonomic symptom in Parkinson's patients and
treatment - currently most often achieved with Fludrocortisone - often leads to supine
hypertension (Plaschke et al., 1998; Braune et al., 1999; Magerkurth et al., 2005).
There are studies in patients with autonomic failure that indicate that Pyridostigmine
bromide might be an alternative treatment option without causing disabling supine
hypertension (Singer et al., 2003; Sandroni et al., 2005; Singer et al., 2006; Yamamoto et
al., 2006).
Delayed gastric emptying is also an autonomic symptom associated with Parkinson's disease. By
the elevation of the cholinergic tone with Pyridostigmine bromide the investigators also
expect to alleviate symptoms of delayed gastric emptying and obstipation, possibly even
facilitating the uptake of dopaminergic medication through the gut (Sadjadpour, 1983;
Bharucha et al., 2008).
Therefore the investigators designed a monocentric randomized, controlled, double blind,
crossover phase II trial to show non-inferiority of the effect of pyridostigmine bromide vs.
fludrocortisone on symptoms of autonomic dysregulation in Parkinson's disease.