Nicergoline Use in Dysphagia Patients

NCT ID: NCT05551182

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia

Keywords

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Dysphagia Stroke Parkinson's disease Dementia Dysphagia improvement Nicergoline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nicergoline low dose

Nicergoline 10 mg bid (20 mg/day)

Group Type EXPERIMENTAL

Nicergoline

Intervention Type DRUG

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

Nicergoline high dose

Nicergoline 30 mg bid (60 mg/day)

Group Type EXPERIMENTAL

Nicergoline

Intervention Type DRUG

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

Interventions

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Nicergoline

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

Intervention Type DRUG

Other Intervention Names

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Sermion

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Silpakorn University

OTHER

Sponsor Role collaborator

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jutikan Imsub, PharmD

Role: STUDY_CHAIR

College of Pharmacy, Burapha university

Sittichoke Sirimontakan, MD

Role: PRINCIPAL_INVESTIGATOR

Phramongkutklao hospital and College of Medicine

Juthathip Suphanklang, BCP

Role: STUDY_DIRECTOR

Phramongkutklao hospital and College of Medicine

Pasiri Sithinamsuwan, MD

Role: STUDY_DIRECTOR

Phramongkutklao hospital and College of Medicine

Locations

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Phramongkutklao Hospital

Ratchathewi, Bangkok, Thailand

Site Status

Countries

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Thailand

Central Contacts

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Jutikan Imsub, PharmD

Role: CONTACT

Phone: 0916976705

Email: [email protected]

Pasiri Sithinamsuwan, MD

Role: CONTACT

Phone: 0832367772

Email: [email protected]

Facility Contacts

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Jutikan Imsub, PharmD

Role: primary

Pasiri Sithinamsuwan, MD

Role: backup

Other Identifiers

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NIDY-2022

Identifier Type: -

Identifier Source: org_study_id