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Nicergoline Use in Dysphagia Patients

Primary Purpose

Dysphagia

Status
Not yet recruiting
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Nicergoline
Sponsored by
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, Stroke, Parkinson's disease, Dementia, Dysphagia improvement, Nicergoline

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phramongkutklao Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nicergoline low dose

Nicergoline high dose

Arm Description

Nicergoline 10 mg bid (20 mg/day)

Nicergoline 30 mg bid (60 mg/day)

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Optimal nicergoline dose for dysphagia improvement.
Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement
Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group.
Evaluated by clinical reported from patients and hospitalization data.
Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group.
Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks.
Rate of cognitive function improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.
Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks.
Adverse side effect in low dose and high dose nicergoline treatment.
Blood sampling for renal function (including creatinine serum, creatinine clearance) and uric serum. Other adverse side effect reported by patients/care givers.

Full Information

First Posted
September 19, 2022
Last Updated
December 21, 2022
Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborators
Silpakorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05551182
Brief Title
Nicergoline Use in Dysphagia Patients
Official Title
The Study of Efficacy on Low Dose Nicergoline in Dysphagia Patients Compares With High Dose Nicergoline.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborators
Silpakorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Dysphagia, Stroke, Parkinson's disease, Dementia, Dysphagia improvement, Nicergoline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nicergoline low dose
Arm Type
Experimental
Arm Description
Nicergoline 10 mg bid (20 mg/day)
Arm Title
Nicergoline high dose
Arm Type
Experimental
Arm Description
Nicergoline 30 mg bid (60 mg/day)
Intervention Type
Drug
Intervention Name(s)
Nicergoline
Other Intervention Name(s)
Sermion
Intervention Description
The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.
Primary Outcome Measure Information:
Title
Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group.
Description
Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week.
Time Frame
4 and 12 weeks
Title
Rate of dysphagia improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.
Description
Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week.
Time Frame
4 and 12 weeks
Title
Relation between MDL level, substanceP and dysphagia improvement after nicergoline administration both groups (low dose and high dose) in steady state.
Description
Blood sampling for MDL level in Ctrough, Cpeak and substanceP at steady state of nicergoline effect.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Optimal nicergoline dose for dysphagia improvement.
Description
Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement
Time Frame
12 weeks
Title
Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group.
Description
Evaluated by clinical reported from patients and hospitalization data.
Time Frame
12 weeks
Title
Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group.
Description
Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks.
Time Frame
12 weeks
Title
Rate of cognitive function improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.
Description
Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks.
Time Frame
12 weeks
Title
Adverse side effect in low dose and high dose nicergoline treatment.
Description
Blood sampling for renal function (including creatinine serum, creatinine clearance) and uric serum. Other adverse side effect reported by patients/care givers.
Time Frame
4 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jutikan Imsub, PharmD
Phone
0916976705
Email
goku2744@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pasiri Sithinamsuwan, MD
Phone
0832367772
Email
pasiripmk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jutikan Imsub, PharmD
Organizational Affiliation
College of Pharmacy, Burapha university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sittichoke Sirimontakan, MD
Organizational Affiliation
Phramongkutklao hospital and College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juthathip Suphanklang, BCP
Organizational Affiliation
Phramongkutklao hospital and College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pasiri Sithinamsuwan, MD
Organizational Affiliation
Phramongkutklao hospital and College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Phramongkutklao Hospital
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jutikan Imsub, PharmD
Phone
0916976705
Email
goku2744@gmail.com
First Name & Middle Initial & Last Name & Degree
Pasiri Sithinamsuwan, MD
Phone
0832367772
Email
pasiripmk@gmail.com
First Name & Middle Initial & Last Name & Degree
Jutikan Imsub, PharmD
First Name & Middle Initial & Last Name & Degree
Sittichoke Sirimontakan, MD
First Name & Middle Initial & Last Name & Degree
Pasiri Sithinamsuwan, MD
First Name & Middle Initial & Last Name & Degree
Juthathip Suphanklang, BCP

12. IPD Sharing Statement

Learn more about this trial

Nicergoline Use in Dysphagia Patients

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