Parkinson's Disease,IdiopathicPhase 4NCT03022201
Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease
A Phase 4 study testing DA-9701 and Domperidone in people with Parkinson's Disease,Idiopathic, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in patients with Parkinson's disease Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Parkinson's Disease,Idiopathic
- What is being tested?
- DA-9701 and Domperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Jun 2016
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects diagnosed with spontaneous parkinsonism by the United Kingdom(UK) Parkinson's Disease Society Brain Bank criteria
- subjects who are able to explain symptoms they experience and to complete relevant assessment and exams including questionaires
- subjects who understand the purpose and protocols of the study and agree to participate on the study
Who cannot join
- subjects who experience psychiatrical disorders such as cognitive or behavioral disorders
- subjects who are on prokinetics or who are unable to cease such medication
- subjects who present neurological disorders which influence gastrointestinal mobility
- subjects who present gastrointestinal conditions which influence gastrointestinal mobility
- subjects with a history of gastrectomy or colectomy
- subjects who are unable to receive and complete the course of medication due to other metabolic disorders
- subjects diagnosed with parkinson plus syndrome
- subjects who are unable to undergo MRI scan for safety reasons due to claustrophobia or certain devices such as cardiac pacemakers or aneurysm clips
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial
This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in patients with Parkinson's disease
Read the detailed description
To prevent nausea and vomiting induced by anti-parkinsonian drugs, prokinetic drugs are frequently prescribed in patients with Parkinson's disease (PD). Additionally, there has been some evidence that prokinetics might improve PD symptom fluctuations. From this background, the investigators will evaluate the therapeutic efficacy and safety of DA-9701 in PD patients.
In this study, 40 patients will be enrolled and randomly allocated 1:1 to receive either domperidone or DA-9701. The gastric function of each study participant will be evaluated using the MRI technique before and after 4 weeks of the treatment. The study participants will also be subjected to complete the gastrointestinal symptom diary before and during the treatment period. In addition, plasma levodopa concentrations will be determined 30 minutes after dose administration before and after treatment.
- Conditions
- Parkinson's Disease,Idiopathic
- Being tested
- DA-9701, Domperidone, Placebo domperidone, Placebo DA-9701
- Keywords
- Motilitone
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-9701Drug
Also called Motilitone
Following 2-week screening period, study participants in this group will be given a standard dose of DA-9701 (30 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.
DomperidoneDrug
Also called Motilium-M
Following 2-week screening period, study participants in this group will be given a standard dose of domperidone (10 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.
Placebo domperidoneDrug
Placebo DA-9701Drug
| Study group | Role | What they receive |
|---|---|---|
| DA-9701 | Experimental | In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks. Receives: Drug: DA-9701; Drug: Placebo domperidone |
| Domperidone | Active comparator | (This study is a randomized, double-blinded, non-inferiority trial. Thus it is designed to have no placebo arm.) In this arm, the study participants will receive domperidone 10mg + placebo DA-9701 tablet tid ac +for 4 weeks. Receives: Drug: Domperidone; Drug: Placebo DA-9701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
MRI is known to be accurate and useful in evaluating gastric motility. Gastric emptying rate (GER) evaluated using MRI will be compared before and after the treatment, and between the groups.
Measured: 0, 4 weeks
Secondary outcomes (3)
Patient's symptoms of dyspepsia and constipation assessed patient diary
The study participants will fill up the gastrointestinal symptom diary before and during the treatment period. In addition, the investigators will assess the Patient's Global Assessment (PGA) for dyspeptic symptoms at the end of the treatment period.
Measured: -1 to 4 weeks
Levodopa plasma concentration 30 minutes after the L-dopa administration
Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment.
Measured: 0, 4 weeks
UPDRS Part III score
To evaluate any deteriorations in Parkinson's disease, the investigators will assess Unified Parkinson's Disease Rating Scale (UPDRS) score before and after treatment in the 2 groups.
Measured: 0, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease,IdiopathicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheol Min Shin, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022201
- Sponsor's protocol ID
- B-1210/173-006
- Status last verified
- Jan 2017
- First submitted
- 23 Nov 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shin CM, Lee YJ, Kim JM, Lee JY, Kim KJ, Choi YJ, Kim N, Lee DH. DA-9701 on gastric motility in patients with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2018 Sep;54:84-89. doi: 10.1016/j.parkreldis.2018.04.018. Epub 2018 Apr 21.
PubMed 29705555
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT03022201
- Acronym / sponsor ID
- B-1210/173-006
- Conditions
- Parkinson's Disease,Idiopathic
- Keywords
- Motilitone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Jan 2017 (estimated)
- 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.
This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in patients with Parkinson's disease
Detailed description
To prevent nausea and vomiting induced by anti-parkinsonian drugs, prokinetic drugs are frequently prescribed in patients with Parkinson's disease (PD). Additionally, there has been some evidence that prokinetics might improve PD symptom fluctuations. From this background, the investigators will evaluate the therapeutic efficacy and safety of DA-9701 in PD patients.
In this study, 40 patients will be enrolled and randomly allocated 1:1 to receive either domperidone or DA-9701. The gastric function of each study participant will be evaluated using the MRI technique before and after 4 weeks of the treatment. The study participants will also be subjected to complete the gastrointestinal symptom diary before and during the treatment period. In addition, plasma levodopa concentrations will be determined 30 minutes after dose administration before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-9701 | Experimental | Drug: DA-9701, Drug: Placebo domperidoneIn this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks. |
| Domperidone | Active comparator | Drug: Domperidone, Drug: Placebo DA-9701(This study is a randomized, double-blinded, non-inferiority trial. Thus it is designed to have no placebo arm.) In this arm, the study participants will receive domperidone 10mg + placebo DA-9701 tablet tid ac +for 4 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects diagnosed with spontaneous parkinsonism by the United Kingdom(UK) Parkinson's Disease Society Brain Bank criteria
- subjects who are able to explain symptoms they experience and to complete relevant assessment and exams including questionaires
- subjects who understand the purpose and protocols of the study and agree to participate on the study
Key exclusion criteria (8 listed)
- subjects who experience psychiatrical disorders such as cognitive or behavioral disorders
- subjects who are on prokinetics or who are unable to cease such medication
- subjects who present neurological disorders which influence gastrointestinal mobility
- subjects who present gastrointestinal conditions which influence gastrointestinal mobility
- subjects with a history of gastrectomy or colectomy
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 |
|---|---|---|
| DA-9701Also: MotilitoneFollowing 2-week screening period, study participants in this group will be given a standard dose of DA-9701 (30 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study. | Drug | DA-9701 |
| DomperidoneAlso: Motilium-MFollowing 2-week screening period, study participants in this group will be given a standard dose of domperidone (10 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study. | Drug | Domperidone |
| Placebo domperidone | Drug | DA-9701 |
| Placebo DA-9701 | Drug | Domperidone |
Primary outcome
Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
Time frame: 0, 4 weeks
MRI is known to be accurate and useful in evaluating gastric motility. Gastric emptying rate (GER) evaluated using MRI will be compared before and after the treatment, and between the groups.
3 secondary outcomes
Patient's symptoms of dyspepsia and constipation assessed patient diary
Time frame: -1 to 4 weeks
Levodopa plasma concentration 30 minutes after the L-dopa administration
Time frame: 0, 4 weeks
UPDRS Part III score
Time frame: 0, 4 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 21 Mar 2019.
- Derived from this study: PubMed 29705555Shin CM, Lee YJ, Kim JM, Lee JY, Kim KJ, Choi YJ, Kim N, Lee DH. DA-9701 on gastric motility in patients with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2018 Sep;54:84-89. doi: 10.1016/j.parkreldis.2018.04.018. Epub 2018 Apr 21.
- 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.
Cheol Min Shin, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DA-9701 and Domperidone in people with Parkinson's Disease,Idiopathic, 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 8 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 21 Mar 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment (time frame: 0, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022201, which also lists 1 linked publication.
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 21 Mar 2019.