Dysphagia
Conditions
Keywords
Dysphagia, Stroke, Parkinson's disease, Dementia, Dysphagia improvement, Nicergoline
Brief summary
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.
Interventions
DRUGNicergoline
The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.
Sponsors
Phramongkutklao College of Medicine and Hospital
Silpakorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group. | 4 and 12 weeks | Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week. |
| Rate of dysphagia improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group. | 4 and 12 weeks | Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week. |
| Relation between MDL level, substanceP and dysphagia improvement after nicergoline administration both groups (low dose and high dose) in steady state. | 4 weeks | Blood sampling for MDL level in Ctrough, Cpeak and substanceP at steady state of nicergoline effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optimal nicergoline dose for dysphagia improvement. | 12 weeks | Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement |
| Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group. | 12 weeks | Evaluated by clinical reported from patients and hospitalization data. |
| Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group. | 12 weeks | Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks. |
| Rate of cognitive function improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group. | 12 weeks | Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks. |
| Adverse side effect in low dose and high dose nicergoline treatment. | 4 and 12 weeks | Blood sampling for renal function (including creatinine serum, creatinine clearance) and uric serum. Other adverse side effect reported by patients/care givers. |
Countries
Thailand
Contacts
STUDY_CHAIRJutikan Imsub, PharmD
College of Pharmacy, Burapha university
PRINCIPAL_INVESTIGATORSittichoke Sirimontakan, MD
Phramongkutklao hospital and College of Medicine
STUDY_DIRECTORJuthathip Suphanklang, BCP
Phramongkutklao hospital and College of Medicine
STUDY_DIRECTORPasiri Sithinamsuwan, MD
Phramongkutklao hospital and College of Medicine
Outcome results
None listed