Nicergoline Use in Dysphagia Patients

Study Overview
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Brief Summary
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Dysphagia is a complication in patient with stroke, Parkinson's disease or dementia that can lead to aspiration pneumonia. This study aimed to investigate dysphagia improvement after treatment with nicergoline low dose and high dose, the relationship between nicergoline dose and clinical improvements, side effect of nicergoline and simulation optimal nicergoline dose in dysphagia improvement.

Official Title
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The Study of Efficacy on Low Dose Nicergoline in Dysphagia Patients Compares With High Dose Nicergoline.

Conditions
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Dysphagia

Intervention / Treatment
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* Drug: Nicergoline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 20 years Stroke (post events at least 2 months), Parkinson's disease and dementia patients who have dysphagia symptom Do not take nicergoline prior recruit 2 weeks Continue current medications Consent to join Exclusion Criteria: Allergy to gentamicin or components On anticoagulants including Heparin, Enoxaparin, Fondaparinux, Warfarin, Dabigatran, Apixaban, Rivaroxaban and Edoxaban On antiplatelet > 1 drug (ex. dual antiplatelet) On ACE-I or Dopaminergic agent 2 months or less Chronic dyspepsia Chronic gout or hyperuricemia > 8 mg/dL CrCl < 30 ml/min Impair hepatic function including child puge B, C or active hepatitis Brainstem stroke Parkinson plus syndrome: PSP, MSA, DLB, etc Advanced cancer or other medical conditions Bed ridden Laryngopharynx surgery SBP<100 or DBP 60 mmHg HR<50/min Active bleeding Pregnancy or lactation Known of poor compliance for any treatments

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicergoline low dose<br>Nicergoline 10 mg bid (20 mg/day) | Drug: Nicergoline<br>* The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.<br>* Other names: Sermion;|
| Experimental: Nicergoline high dose<br>Nicergoline 30 mg bid (60 mg/day) | Drug: Nicergoline<br>* The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.<br>* Other names: Sermion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group. | Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week. | 4 and 12 weeks | 
| Rate of dysphagia improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group. | Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week. | 4 and 12 weeks | 
| Relation between MDL level, substanceP and dysphagia improvement after nicergoline administration both groups (low dose and high dose) in steady state. | Blood sampling for MDL level in Ctrough, Cpeak and substanceP at steady state of nicergoline effect. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal nicergoline dose for dysphagia improvement. | Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement | 12 weeks | 
| Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group. | Evaluated by clinical reported from patients and hospitalization data. | 12 weeks | 
| Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group. | Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks. | 12 weeks | 
| Rate of cognitive function improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group. | Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks. | 12 weeks | 
| Adverse side effect in low dose and high dose nicergoline treatment. | Blood sampling for renal function (including creatinine serum, creatinine clearance) and uric serum. Other adverse side effect reported by patients/care givers. | 4 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Stroke, Parkinson's disease, Dementia, Dysphagia improvement, Nicergoline