Parkinson's DiseasePhase 1BUS-PDNCT02589340
Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
A Phase 1 study testing Buspirone in people with Parkinson's Disease and Dyskinesias, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy of buspirone in combination with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson's Disease, Dyskinesias, Movement Disorders
- What is being tested?
- Buspirone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 23 Feb 2021
- Phase
- Phase 1
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease diagnosis
- Currently taking a levodopa containing medication for Parkinson's disease
- Mild to Severe dyskinesia
- Currently taking between 200-500 mg of amantadine daily for treatment of levodopa-induced dyskinesia with insufficient suppression levodopa-induced dyskinesia.
- Stable medication regimen for at least 4 weeks prior to study.
Who cannot join
- Currently receiving any other treatment for levodopa-induced dyskinesia, including but not exclusive to deep brain stimulation.
- Not able to follow verbal commands
- Not able to stand unsupported for at least 60 seconds
- Not able to answer a patient questionnaire about their symptoms of Parkinson's disease and dyskinesia.
- Have proprioceptive deficits.
- Have a history of hepatic impairment
Show all 12Show fewer
- Currently have severe renal impairment
- Currently have any other medical or psychiatric diagnosis that would preclude their ability to safely participate in the study.
- Significant cognitive impairment
- Pregnancy
- Breast-Feeding
- Unable to swallow study drug (capsule)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System
Portland, Oregon, 97239
About this study
The primary objective of this study is to evaluate the efficacy of buspirone in combination with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
Read the detailed description
Plan: We will perform a randomized, placebo-controlled, double-blind, two-period cross-over study to evaluate the safety, tolerability, and efficacy of a novel treatment combination for LID in PD.
Methods: Eligible subjects who consent to participate in this study will be randomized to one of two sequences of treatment interventions during the baseline visit. Each treatment sequence includes placebo and buspirone interventions. After randomization, each participant will titrate up on study drug for two weeks ending in 30 mg/day. At the end of each two week study drug period, the participant will then have a study visit at the VA Portland Health Care System that includes safety monitoring, adverse event monitoring, drug compliance, and several measurements of LID.
- Conditions
- Parkinson's Disease, Dyskinesias, Movement Disorders
- Being tested
- Buspirone, Placebo
- Medical subject headings
- Parkinson Disease, Dyskinesias, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
PlaceboDrug
Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| Buspirone | Experimental | Two week titration up to 10 mg tablet/3 times a day for 7 days Receives: Drug: Buspirone |
| Placebo | Placebo comparator | Two week titration up to 3 tablets/3 times a day for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve - Dyskinesia - Forceplate
forceplate measurements of levodopa induced dyskinesia taken every 1/2 hour for 6 hours.
Measured: 6 hour levodopa dose cycle
Dyskinesia - UDysRS
UDysRS total score comparison
Measured: up to 6 weeks
Adverse Events
Adverse Events Monitoring/Frequency
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startJan 2016
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Why it stopped: Low enrollment
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 DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland VA Medical Center
- Responsible party
- Principal investigator, Kathryn Anne Chung, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589340
- Sponsor's protocol ID
- 11875
- Acronym
- BUS-PD
- Status last verified
- Mar 2021
- First submitted
- 23 Oct 2015
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
PubMed 31356217
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
- ClinicalTrials.gov ID
- NCT02589340
- Acronym / sponsor ID
- BUS-PD / 11875
- Conditions
- Parkinson's Disease, Dyskinesias, Movement Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Portland VA Medical Center
- Study start
- Jan 2016
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 28 Oct 2015 (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.
The primary objective of this study is to evaluate the efficacy of buspirone in combination with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
Detailed description
Plan: We will perform a randomized, placebo-controlled, double-blind, two-period cross-over study to evaluate the safety, tolerability, and efficacy of a novel treatment combination for LID in PD.
Methods: Eligible subjects who consent to participate in this study will be randomized to one of two sequences of treatment interventions during the baseline visit. Each treatment sequence includes placebo and buspirone interventions. After randomization, each participant will titrate up on study drug for two weeks ending in 30 mg/day. At the end of each two week study drug period, the participant will then have a study visit at the VA Portland Health Care System that includes safety monitoring, adverse event monitoring, drug compliance, and several measurements of LID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buspirone | Experimental | Drug: BuspironeTwo week titration up to 10 mg tablet/3 times a day for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboTwo week titration up to 3 tablets/3 times a day for 7 days |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parkinson's disease diagnosis
- Currently taking a levodopa containing medication for Parkinson's disease
- Mild to Severe dyskinesia
- Currently taking between 200-500 mg of amantadine daily for treatment of levodopa-induced dyskinesia with insufficient suppression levodopa-induced dyskinesia.
- Stable medication regimen for at least 4 weeks prior to study.
Key exclusion criteria (12 listed)
- Currently receiving any other treatment for levodopa-induced dyskinesia, including but not exclusive to deep brain stimulation.
- Not able to follow verbal commands
- Not able to stand unsupported for at least 60 seconds
- Not able to answer a patient questionnaire about their symptoms of Parkinson's disease and dyskinesia.
- Have proprioceptive deficits.
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 |
|---|---|---|
| Buspirone | Drug | Buspirone |
| PlaceboSugar Pill | Drug | Placebo |
Primary outcome
Area Under the Curve - Dyskinesia - Forceplate
Time frame: 6 hour levodopa dose cycle
forceplate measurements of levodopa induced dyskinesia taken every 1/2 hour for 6 hours.
Dyskinesia - UDysRS
Time frame: up to 6 weeks
UDysRS total score comparison
Adverse Events
Time frame: up to 6 weeks
Adverse Events Monitoring/Frequency
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Derived from this study: PubMed 31356217McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
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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 Phase 1 study testing Buspirone in people with Parkinson's Disease and Dyskinesias, run by Oregon Health and Science University at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 5 Mar 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Low enrollment). 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?
Area Under the Curve - Dyskinesia - Forceplate (time frame: 6 hour levodopa dose cycle). 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?
On the ClinicalTrials.gov record for NCT02589340, 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 5 Mar 2021.