Nicergoline Use in Dysphagia Patients

December 21, 2022 updated by: Phramongkutklao College of Medicine and Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jutikan Imsub, PharmD
        • Principal Investigator:
          • Sittichoke Sirimontakan, MD
        • Principal Investigator:
          • Pasiri Sithinamsuwan, MD
        • Sub-Investigator:
          • Juthathip Suphanklang, BCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Time Frame: 4 and 12 weeks
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.
Time Frame: 4 weeks
Blood sampling for MDL level in Ctrough, Cpeak and substanceP at steady state of nicergoline effect.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal nicergoline dose for dysphagia improvement.
Time Frame: 12 weeks
Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
4 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDY-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dysphagia

Clinical Trials on Nicergoline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe