DysphagiaPhase 3NCT05551182
Nicergoline Use in Dysphagia Patients
A Phase 3 study testing Nicergoline in people with Dysphagia, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Nicergoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2023to 20 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dysphagia
- Being tested
- Nicergoline
- Keywords
- Dysphagia, Stroke, Parkinson's disease, Dementia, Dysphagia improvement, Nicergoline
- Medical subject headings
- Deglutition Disorders, Stroke, Parkinson Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicergolineDrug
Also called Sermion
The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nicergoline low dose | Experimental | Nicergoline 10 mg bid (20 mg/day) Receives: Drug: Nicergoline |
| Nicergoline high dose | Experimental | Nicergoline 30 mg bid (60 mg/day) Receives: Drug: Nicergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week.
Measured: 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.
Blood sampling for MDL level in Ctrough, Cpeak and substanceP at steady state of nicergoline effect.
Measured: 4 weeks
Secondary outcomes (5)
Optimal nicergoline dose for dysphagia improvement.
Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement
Measured: 12 weeks
Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group.
Evaluated by clinical reported from patients and hospitalization data.
Measured: 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Jan 2023
- Primary completion31 Jul 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Silpakorn University
- Responsible party
- Sponsor
- Investigators
- Jutikan Imsub, PharmD, Study chair, College of Pharmacy, Burapha universitySittichoke Sirimontakan, MD, Principal investigator, Phramongkutklao hospital and College of MedicineJuthathip Suphanklang, BCP, Study director, Phramongkutklao hospital and College of MedicinePasiri Sithinamsuwan, MD, Study director, Phramongkutklao hospital and College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551182
- Sponsor's protocol ID
- NIDY-2022
- Status last verified
- Dec 2022
- First submitted
- 19 Sep 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Efficacy on Low Dose Nicergoline in Dysphagia Patients Compares With High Dose Nicergoline.
- ClinicalTrials.gov ID
- NCT05551182
- Acronym / sponsor ID
- NIDY-2022
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Stroke, Parkinson's disease, Dementia, Dysphagia improvement, Nicergoline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Collaborators
- Silpakorn University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicergoline low dose | Experimental | Drug: NicergolineNicergoline 10 mg bid (20 mg/day) |
| Nicergoline high dose | Experimental | Drug: NicergolineNicergoline 30 mg bid (60 mg/day) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicergolineAlso: SermionThe participants in both arms will receive nicergoline for treatment dysphagia 12 weeks. | Drug | Nicergoline high dose, Nicergoline low dose |
Primary outcome
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.
5 secondary outcomes
Optimal nicergoline dose for dysphagia improvement.
Time frame: 12 weeks
Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group.
Time frame: 12 weeks
Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group.
Time frame: 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
Adverse side effect in low dose and high dose nicergoline treatment.
Time frame: 4 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicergoline in people with Dysphagia, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group. (time frame: 4 and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.