Nicergoline Use in Dysphagia Patients

Sponsor

Phramongkutklao College of Medicine and Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05551182

Collaborator

Silpakorn University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia	Drug: Nicergoline	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nicergoline low dose Nicergoline 10 mg bid (20 mg/day)	Drug: Nicergoline The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks. Other Names: Sermion
Experimental: Nicergoline high dose Nicergoline 30 mg bid (60 mg/day)	Drug: Nicergoline The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks. Other Names: Sermion

Arm

Intervention/Treatment

Experimental: Nicergoline low dose

Nicergoline 10 mg bid (20 mg/day)

Drug: Nicergoline

The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.

Other Names:

Sermion

Experimental: Nicergoline high dose

Nicergoline 30 mg bid (60 mg/day)

Drug: Nicergoline

The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.

Other Names:

Sermion

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phramongkutklao Hospital	Ratchathewi	Bangkok	Thailand	10400

Sponsors and Collaborators

Phramongkutklao College of Medicine and Hospital
Silpakorn University

Investigators

Study Chair: Jutikan Imsub, PharmD, College of Pharmacy, Burapha university
Principal Investigator: Sittichoke Sirimontakan, MD, Phramongkutklao hospital and College of Medicine
Study Director: Juthathip Suphanklang, BCP, Phramongkutklao hospital and College of Medicine
Study Director: Pasiri Sithinamsuwan, MD, Phramongkutklao hospital and College of Medicine