Parkinson DiseaseNCT04260581
Is Long-term Use of Amantadine Effective in PD?
A study testing Determination of drug effects through amantadine cessation in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigator aims to assess whether long-term use of amantadine is effective in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Determination of drug effects through amantadine cessation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2020to 28 Feb 2021
- Phase
- Interventional
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have been taking amantadine since the beginning of diagnosis
- Patients who have taken amantadine for more than five years
- Patients with Parkinson's disease who are aged 40 years or older
Who cannot join
- Patient who stops amantadine or is hypersensitive to amantadine
- Patients who have undergone brain surgery, including deep brain stimulation
- Patient identified as atypical parkinsonism
- Patients with psychiatric conditions such as dementia, major depression or bipolar disorder who are difficult to assess
- Patients who are currently unable to follow up at our hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Long-term Use of Amantadine Effective in Parkinson Disease?
The investigator aims to assess whether long-term use of amantadine is effective in patients with Parkinson's disease.
Read the detailed description
Amantadine is used in the early stages of Parkinson's disease (PD). However, amantadine is known to be relatively weak compared to other antiparkinsonian drugs such as levodopa, dopamine agonist or Mao-B inhibitor and its effects are limited in early months, so it is rarely used than other drugs.
Recently, several studies have identified the long-term effects of amantadine on dyskinesia, but the basis is still insufficient.
Therefore, this study aims to investigate the long-term effectiveness of amantadine in patients with PD. Participants who have used amantadine since the early stages of diagnosis undergo clinical evaluations including the Montreal Cognitive Assessment (MoCA), Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Freezing of Gait-Questionnaire (FOG-Q), Non-motor Symptom Scale (NMSS) and Parkinson's Disease Questionnaire-39 (PDQ-39). Then, participants stop taking amantadine. To investigate the long-term effect, clinical evaluations except MoCA are repetitively assessed at 4- and 8-week follow-ups.
- Conditions
- Parkinson Disease
- Being tested
- Determination of drug effects through amantadine cessation
- Keywords
- Parkinson's disease, Amantadine, Long-term effect
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of drug effects through amantadine cessationDrug
Patients will discontinue amantadine, which has been taken since beginning of diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| PD patients who have taken amantadine | Experimental | Not described Receives: Drug: Determination of drug effects through amantadine cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 132]
Measured: Baseline, 4 weeks
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 132]
Measured: Baseline, 8 weeks
Secondary outcomes (14)
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 52]
Measured: Baseline, 4 weeks
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 52]
Measured: Baseline, 8 weeks
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 52]
Measured: Baseline, 4 weeks
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 52]
Measured: Baseline, 8 weeks
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24]
Measured: Baseline, 4 weeks
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24]
Measured: Baseline, 8 weeks
Change from baseline to 4-week f/u in Hohr and Yahr stage score
Hohr and Yahr stage score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 5]
Measured: Baseline, 4 weeks
Change from baseline to 8-week f/u in Hohr and Yahr stage score
Hohr and Yahr stage score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 5]
Measured: Baseline, 8 weeks
Change from baseline to 4-week f/u in Freezing of Gait Questionnaire score
Freezing of Gait Questionnaire score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24]
Measured: Baseline, 4 weeks
Change from baseline to 8-week f/u in Freezing of Gait Questionnaire score
Freezing of Gait Questionnaire score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 24]
Measured: Baseline, 8 weeks
Change from baseline to 4-week f/u in Non-motor Symptom Scale score
Non-motor Symptom Scale score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 360]
Measured: Baseline, 4 weeks
Change from baseline to 8-week f/u in Non-motor Symptom Scale score
Non-motor Symptom Scale score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 360]
Measured: Baseline, 8 weeks
Change from baseline to 4-week f/u in Parkinson's Disease Questionnaire-39 score
Parkinson's Disease Questionnaire-39 score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 156]
Measured: Baseline, 4 weeks
Change from baseline to 8-week f/u in Parkinson's Disease Questionnaire-39 score
Parkinson's Disease Questionnaire-39 score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 156]
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BS Jeon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260581
- Sponsor's protocol ID
- H-1909-072-1064
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Long-term Use of Amantadine Effective in Parkinson Disease?
- ClinicalTrials.gov ID
- NCT04260581
- Acronym / sponsor ID
- H-1909-072-1064
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Amantadine, Long-term effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 7 Feb 2020 (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.
The investigator aims to assess whether long-term use of amantadine is effective in patients with Parkinson's disease.
Detailed description
Amantadine is used in the early stages of Parkinson's disease (PD). However, amantadine is known to be relatively weak compared to other antiparkinsonian drugs such as levodopa, dopamine agonist or Mao-B inhibitor and its effects are limited in early months, so it is rarely used than other drugs.
Recently, several studies have identified the long-term effects of amantadine on dyskinesia, but the basis is still insufficient.
Therefore, this study aims to investigate the long-term effectiveness of amantadine in patients with PD. Participants who have used amantadine since the early stages of diagnosis undergo clinical evaluations including the Montreal Cognitive Assessment (MoCA), Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Freezing of Gait-Questionnaire (FOG-Q), Non-motor Symptom Scale (NMSS) and Parkinson's Disease Questionnaire-39 (PDQ-39). Then, participants stop taking amantadine. To investigate the long-term effect, clinical evaluations except MoCA are repetitively assessed at 4- and 8-week follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patients who have taken amantadine | Experimental | Drug: Determination of drug effects through amantadine cessation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have been taking amantadine since the beginning of diagnosis
- Patients who have taken amantadine for more than five years
- Patients with Parkinson's disease who are aged 40 years or older
Key exclusion criteria (5 listed)
- Patient who stops amantadine or is hypersensitive to amantadine
- Patients who have undergone brain surgery, including deep brain stimulation
- Patient identified as atypical parkinsonism
- Patients with psychiatric conditions such as dementia, major depression or bipolar disorder who are difficult to assess
- Patients who are currently unable to follow up at our hospital
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 |
|---|---|---|
| Determination of drug effects through amantadine cessationPatients will discontinue amantadine, which has been taken since beginning of diagnosis. | Drug | PD patients who have taken amantadine |
Primary outcome
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
Time frame: Baseline, 4 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 132]
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
Time frame: Baseline, 8 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. [minimum 0, maximum 132]
14 secondary outcomes
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score
Time frame: Baseline, 4 weeks
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score
Time frame: Baseline, 8 weeks
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score
Time frame: Baseline, 4 weeks
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score
Time frame: Baseline, 8 weeks
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score
Time frame: Baseline, 4 weeks
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score
Time frame: Baseline, 8 weeks
Change from baseline to 4-week f/u in Hohr and Yahr stage score
Time frame: Baseline, 4 weeks
Change from baseline to 8-week f/u in Hohr and Yahr stage score
Time frame: Baseline, 8 weeks
Change from baseline to 4-week f/u in Freezing of Gait Questionnaire score
Time frame: Baseline, 4 weeks
Change from baseline to 8-week f/u in Freezing of Gait Questionnaire score
Time frame: Baseline, 8 weeks
Change from baseline to 4-week f/u in Non-motor Symptom Scale score
Time frame: Baseline, 4 weeks
Change from baseline to 8-week f/u in Non-motor Symptom Scale score
Time frame: Baseline, 8 weeks
Change from baseline to 4-week f/u in Parkinson's Disease Questionnaire-39 score
Time frame: Baseline, 4 weeks
Change from baseline to 8-week f/u in Parkinson's Disease Questionnaire-39 score
Time frame: Baseline, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determination of drug effects through amantadine cessation in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Feb 2020. 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 South Korea. 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.
Are results available for this study?
Results are not available in the source record.
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?
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score (time frame: Baseline, 4 weeks). The study lists 2 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 7 Feb 2020.