Clinical Efficacy and Safety Evaluation of Nicergoline in Patients With Neurological Dysphagia.

Overview

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.

Full Title of Study: “The Study of Efficacy on Low Dose Nicergoline in Dysphagia Patients Compares With High Dose Nicergoline.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2022

Interventions

  • Drug: Nicergoline
    • The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.

Arms, Groups and Cohorts

  • Experimental: Nicergoline low dose
    • Nicergoline 10 mg bid (20 mg/day)
  • Experimental: Nicergoline high dose
    • Nicergoline 30 mg bid (60 mg/day)

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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 Measures

  • Optimal nicergoline dose for dysphagia improvement.
    • Time Frame: 12 weeks
    • 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.
    • Time Frame: 12 weeks
    • Evaluated by clinical reported from patients and hospitalization data.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Phramongkutklao College of Medicine and Hospital
  • Collaborator
    • Silpakorn University Faculty of Pharmacy
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jutikan Imsub, PharmD, Study Chair, College of Pharmacy, Burapha university
    • Sittichoke Sirimontakan, MD, Principal Investigator, Phramongkutklao hospital and College of Medicine
    • Juthathip Suphanklang, BCP, Study Director, Phramongkutklao hospital and College of Medicine
    • Pasiri Sithinamsuwan, MD, Study Director, Phramongkutklao hospital and College of Medicine
  • Overall Contact(s)
    • Jutikan Imsub, PharmD, 0916976705, goku2744@gmail.com

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