Clinical trial NCT05551182: Nicergoline Use in Dysphagia Patients
Official title: The Study of Efficacy on Low Dose Nicergoline in Dysphagia Patients Compares With High Dose Nicergoline.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Dysphagia
Keywords: Dysphagia
Stroke
Parkinson's disease
Dementia
Dysphagia improvement
Nicergoline
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
Collaborators: name: Silpakorn University
First posted: 2022-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group.
timeFrame: 4 and 12 weeks
measure: Rate of dysphagia improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.
timeFrame: 4 and 12 weeks
measure: Relation between MDL level, substanceP and dysphagia improvement after nicergoline administration both groups (low dose and high dose) in steady state.
timeFrame: 4 weeks
Secondary outcomes:
measure: Optimal nicergoline dose for dysphagia improvement.
timeFrame: 12 weeks
measure: Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group.
timeFrame: 12 weeks
measure: Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group.
timeFrame: 12 weeks
measure: Rate of cognitive function improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.
timeFrame: 12 weeks
measure: Adverse side effect in low dose and high dose nicergoline treatment.
timeFrame: 4 and 12 weeks
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Phramongkutklao Hospital
state: Bangkok
Study officials:
affiliation: College of Pharmacy, Burapha university
name: Jutikan Imsub, PharmD
role: STUDY_CHAIR
affiliation: Phramongkutklao hospital and College of Medicine
name: Sittichoke Sirimontakan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Phramongkutklao hospital and College of Medicine
name: Juthathip Suphanklang, BCP
role: STUDY_DIRECTOR
affiliation: Phramongkutklao hospital and College of Medicine
name: Pasiri Sithinamsuwan, MD
role: STUDY_DIRECTOR
References: