Clinical Efficacy and Safety Evaluation of Nicergoline in Patients With Neurological Dysphagia.

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phramongkutklao College of Medicine and Hospital
• Collaborator: Silpakorn University Faculty of Pharmacy
• Treatments: Nicergoline

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