Nicergoline Use in Dysphagia Patients

NCT05551182 | Completed Phase 3

• 1 other identifier: NIDY-2022
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

Dysphagia; Stroke; Parkinson's disease; Dementia; Dysphagia improvement; Nicergoline

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Optimal nicergoline dose for dysphagia improvement.

  12 weeks

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

  12 weeks

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

  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

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

  4 and 12 weeks

Study Arms (2)

Nicergoline low dose

EXPERIMENTAL

Nicergoline 10 mg bid (20 mg/day)

Drug: Nicergoline

Nicergoline high dose

EXPERIMENTAL

Nicergoline 30 mg bid (60 mg/day)

Drug: Nicergoline

Interventions

Nicergoline DRUG

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

Also known as: Sermion

Nicergoline high dose; Nicergoline low dose

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead
• Silpakorn University: collaborator

Study Sites (1)

Phramongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Deglutition Disorders; Stroke; Parkinson Disease; Dementia

Interventions

Nicergoline

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jutikan Imsub, PharmD

  College of Pharmacy, Burapha university

  STUDY CHAIR

• Sittichoke Sirimontakan, MD

  Phramongkutklao hospital and College of Medicine

  PRINCIPAL INVESTIGATOR

• Juthathip Suphanklang, BCP

  Phramongkutklao hospital and College of Medicine

  STUDY DIRECTOR

• Pasiri Sithinamsuwan, MD

  Phramongkutklao hospital and College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: January 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: August 20, 2025
• Last Updated: March 4, 2026

Record last verified: 2022-12

Locations

TH (1)