Nicergoline Use in Dysphagia Patients

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05551182
• Other study ID #: NIDY-2022
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2023
• Est. completion date: August 2025

Study information

• Verified date: December 2022
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: Jutikan Imsub, PharmD
• Phone: 0916976705
• Email: goku2744[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Drug:
• Nicergoline
The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.

Locations

Country	Name	City	State
Thailand	Phramongkutklao Hospital	Ratchathewi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital	Silpakorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Optimal nicergoline dose for dysphagia improvement.	Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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