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Nicergoline Use in Dysphagia Patients

Phase 3
Not yet recruiting
Conditions
Dysphagia
Interventions
Registration Number
NCT05551182
Lead Sponsor
Phramongkutklao College of Medicine and Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
60
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Nicergoline low doseNicergolineNicergoline 10 mg bid (20 mg/day)
Nicergoline high doseNicergolineNicergoline 30 mg bid (60 mg/day)
Primary Outcome Measures
NameTimeMethod
Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group.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.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.4 weeks

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

Secondary Outcome Measures
NameTimeMethod
Rate of cognitive function improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.12 weeks

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

Optimal nicergoline dose for dysphagia improvement.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.12 weeks

Evaluated by clinical reported from patients and hospitalization data.

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

Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group.12 weeks

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

Trial Locations

Locations (1)

Phramongkutklao Hospital

🇹🇭

Ratchathewi, Bangkok, Thailand

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