Parkinson DiseasePhase 2NCT02803749
Buspirone in Parkinson's Disease
A Phase 2 study testing Buspirone in people with Parkinson Disease and Anxiety, run by University of Rochester at 1 site in United States.
Trial summary
Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet it frequently remains untreated and there have been no clinical trials dedicated to evaluating the pharmacological treatment of anxiety in Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Anxiety
- What is being tested?
- Buspirone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 25 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD by UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
- Significant anxiety as determined by the self-rated Parkinson Anxiety Scale (score ≥ 14)
- Able to provide written informed consent
- At least 18 years of age
Who cannot join
- Diagnosis of atypical or secondary parkinsonism
- Concomitant treatment with an MAO inhibitor within the 14 days prior to screening visit
- Significant renal or hepatic impairment
- Significant cognitive impairment defined as MOCA score < 23
- On-going depression with suicidal or homicidal ideation and concern for patient safety based on clinical determination by the investigator
- Allergy or intolerance to study drug, matching placebo, or their formulations
Show all 14Show fewer
- History of prior exposure to study drug
- Lactating or pregnant woman
- Concomitant treatment with a disallowed medication (detailed in section 6.2)
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Concomitant treatment with an anxiolytic or antidepressant will be allowed however potential participants who had dosage changes in the 30 days prior to the screening visit will be excluded
- Use of an investigational drug within 30 days prior to screening visit
- Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation
- Dysphagia defined as a score of ≥ 2 on MDS-UPDRS Item 2.3 Chewing and Swallowing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14618
About this study
Official title: The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease
Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet it frequently remains untreated and there have been no clinical trials dedicated to evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is effective for the treatment of generalized anxiety disorder in the general and elderly population. It is not known if it is effective for the treatment of anxiety in Parkinson's disease. This is a single-center, placebo-controlled, double-blind design with participants randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg twice daily) or placebo for 12 weeks.
- Conditions
- Parkinson Disease, Anxiety
- Being tested
- Buspirone, Placebo
- Medical subject headings
- Parkinson Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Buspirone | Experimental | Flexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks. Receives: Drug: Buspirone |
| Placebo | Placebo comparator | Flexible dosage placebo for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
Measured: 12 weeks
Secondary outcomes (7)
Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks
The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Measured: 12 weeks
Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks
The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.
Measured: 12 weeks
Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks
The PGI-I assesses patient global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."
Measured: 12 weeks
Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)
The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively.
Measured: baseline to 12 weeks
Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks
The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias.
Measured: 12 weeks
Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks
The CGI-I assesses clinician global impression of improvement on a 7-point scale where 1 = "very much improved" and 7 = "very much worse."
Measured: 12 weeks
Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks
The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Irene Richard, University of Rochester
- Investigators
- Irene Richard, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803749
- Sponsor's protocol ID
- 61141
- Status last verified
- Dec 2019
- First submitted
- 14 Jun 2016
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02803749
- Acronym / sponsor ID
- 61141
- Conditions
- Parkinson Disease, Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Oct 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet it frequently remains untreated and there have been no clinical trials dedicated to evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is effective for the treatment of generalized anxiety disorder in the general and elderly population. It is not known if it is effective for the treatment of anxiety in Parkinson's disease. This is a single-center, placebo-controlled, double-blind design with participants randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg twice daily) or placebo for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buspirone | Experimental | Drug: BuspironeFlexible dosage buspirone (maximum dosage 30 mg twice daily) for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboFlexible dosage placebo for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic PD by UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
- Significant anxiety as determined by the self-rated Parkinson Anxiety Scale (score ≥ 14)
- Able to provide written informed consent
- At least 18 years of age
Key exclusion criteria (14 listed)
- Diagnosis of atypical or secondary parkinsonism
- Concomitant treatment with an MAO inhibitor within the 14 days prior to screening visit
- Significant renal or hepatic impairment
- Significant cognitive impairment defined as MOCA score < 23
- On-going depression with suicidal or homicidal ideation and concern for patient safety based on clinical determination by the investigator
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 |
| Placebo | Drug | Placebo |
Primary outcome
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.
Time frame: 12 weeks
7 secondary outcomes
Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks
Time frame: 12 weeks
Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks
Time frame: 12 weeks
Number of "Much Improved" or "Very Much Improved" on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks
Time frame: 12 weeks
Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline to 12 weeks
Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks
Time frame: 12 weeks
Number of "Much Improved" or "Very Much Improved" on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks
Time frame: 12 weeks
Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Irene Richard, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buspirone in people with Parkinson Disease and Anxiety, run by University of Rochester 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 4 inclusion and 14 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 2 Jan 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants Who Fail to Complete the 12-week Study on Study Drug. (time frame: 12 weeks). 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 2 Jan 2020.