CompletedPhase 3

Nicergoline Use in Dysphagia Patients

Thailand92 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group.

Timeframe: 4 and 12 weeks

Rate of dysphagia improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.

Timeframe: 4 and 12 weeks

Relation between MDL level, substanceP and dysphagia improvement after nicergoline administration both groups (low dose and high dose) in steady state.

Timeframe: 4 weeks

Trial details

NCT IDNCT05551182

SponsorPhramongkutklao College of Medicine and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Dysphagia trials

Plain-language summary

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group.

Timeframe: 4 and 12 weeks

Rate of dysphagia improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.

Timeframe: 4 and 12 weeks

Relation between MDL level, substanceP and dysphagia improvement after nicergoline administration both groups (low dose and high dose) in steady state.

Timeframe: 4 weeks