Nicergoline Use in Dysphagia Patients

Phramongkutklao College of Medicine and Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Dysphagia

Treatments: Drug: Nicergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT05551182

NIDY-2022

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Nicergoline low dose

Experimental group

Description:

Nicergoline 10 mg bid (20 mg/day)

Treatment:

Drug: Nicergoline

Nicergoline high dose

Experimental group

Description:

Nicergoline 30 mg bid (60 mg/day)

Treatment:

Drug: Nicergoline