Nicergoline Use in Dysphagia Patients
- 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
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nicergoline low dose Nicergoline Nicergoline 10 mg bid (20 mg/day) Nicergoline high dose Nicergoline Nicergoline 30 mg bid (60 mg/day)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
🇹ðŸ‡Ratchathewi, Bangkok, Thailand