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NCT Number: NCT05551182

Nicergoline Use in Dysphagia Patients

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.

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Key information

Conditions

Dysphagia Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Dementia Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Otorhinolaryngologic Diseases Parkinson Disease Parkinsonian Disorders Pharyngeal Diseases Stroke Synucleinopathies Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phramongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicergoline

Drug

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

Other names: Sermion

Primary outcomes

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

    Time frame: 4 and 12 weeks

    Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week.

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

    Time frame: 4 and 12 weeks

    Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week.

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

    Time frame: 4 weeks

    Blood sampling for MDL level in Ctrough, Cpeak and substanceP at steady state of nicergoline effect.

Secondary outcomes

  1. Optimal nicergoline dose for dysphagia improvement.

    Time frame: 12 weeks

    Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement

  2. Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group.

    Time frame: 12 weeks

    Evaluated by clinical reported from patients and hospitalization data.

  3. Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group.

    Time frame: 12 weeks

    Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks.

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

    Time frame: 12 weeks

    Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks.

  5. Adverse side effect in low dose and high dose nicergoline treatment.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Other

Collaborators

  • Silpakorn University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2022
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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