Parkinson's DiseasePhase 2NCT02066571
Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease
A Phase 2 study testing Droxidopa and sugar pill in people with Parkinson's Disease and Freezing of Gait, run by Henry Ford Health System at 2 sites in United States.
Trial summary
Since droxidopa has been approved in Japan for treating freezing of gait in Parkinson's disease patients, this is to confirm and further investigate the safety and efficacy using a similar dose. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Freezing of Gait, Cognitive Ability, General
- What is being tested?
- Droxidopa and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2015to Dec 2017
- Phase
- Phase 2
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide written informed consent to participate in the study
- Diagnosed with probable levodopa-responsive idiopathic PD (meeting United Kingdom PD Brain Bank diagnostic criteria), and receiving levodopa therapy for this disorder. Other PD medications can also be used.
- Must have AT LEAST ONE of below two criteria:
- At least 3 months incidence of typical freezing of gait symptoms, occurring while levodopa is otherwise providing an "on" mobility state (including at least one of the following Freezing of Gait patterns: start hesitancy, freezing at making turns or when passing through a doorway, spontaneous freezing during continued walking, or Freezing of Gait related to a simultaneous mental or physical activity) OR
- Have a screening score between 22 and 26 (inclusive) on the Montreal Cognitive Assessment
Who cannot join
- Taking direct acting vasoconstriction agent (i.e. ephedrine or midodrine). Subjects taking vasoconstrictor agents such as ephedrine or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit
- Taking anti-hypertensive medication for the treatment of hypertension. Anti-hypertensive medication taken at night to prevent supine hypertension will be allowed
- Changing dose or frequency of PD medication within 2 weeks of baseline
- Use of cognitive-enhancing medications (donepezil, galantamine, rivastigmine, tacrine, or memantine), catechol-O-methyltransferase inhibitors (tolcapone or entacapone), anticholinergic drugs, or antipsychotic drugs (including quetiapine or clozapine).
- Known or suspected alcohol or substance abuse within 1 year (e.g. DSM-IV definition of alcoholism)
- Past or current history of chronic severe hypertension (with repeated findings of BP 150/90 mmHg in the supine or standing position)
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- Symptomatic coronary artery disease, severe congestive heart failure (NYHA Class 3 or 4)
- Unable to remain off any effective Freezing of Gait medications for 12 hrs prior to Evaluation visits)
- Women who are pregnant, lactating, or plan to become pregnant during the course of this study
- Women of child bearing potential who are not using two methods of contraception (at least one barrier, i.e. condom) with their partner.
- Male subjects who are sexually active with a woman of child bearing potential and not using two methods of contraception (at least one barrier, for example, condom)
- A history of closed angle glaucoma;
- Active (in the last 6 months) atrial fibrillation or, in the investigator's opinion, any other significant cardiac arrhythmia that should preclude the subject from this trial
- History of myocardial infarction or unstable angina
- Congestive heart failure (NYHA Class 3 or 4)
- Diabetes insipidus, insulin-dependent diabetes mellitus, or diabetic neuropathy
- In the investigator's opinion, any other significant systemic illness
- Known or suspected malignancy (other than basal cell carcinoma)
- Known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator's opinion, affect the absorption of study drug
- Any major surgical procedure within 30 days of the baseline visit
- Currently receiving any investigational drug or have received an investigational drug within 30 days of the baseline visit
- In the investigator's opinion, clinically significant abnormalities on clinical examination or laboratory testing that should preclude the subject from this trial.
- Findings from suicidality screening that are compatible with risk for suicide
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Henry Ford Hospital, West Bloomfield
West Bloomfield, Michigan, 48322
About this study
Official title: A Phase II, Double-Blind, Placebo-Controlled, Crossover Study to Assess Clinical Benefit and Safety of Droxidopa in the Treatment of Parkinson's Disease
Since droxidopa has been approved in Japan for treating freezing of gait in Parkinson's disease patients, this is to confirm and further investigate the safety and efficacy using a similar dose. The possible beneficial effects on cognition in mildly cognitively impaired Parkinson's disease patients will also be tested, since this problem in Parkinson's disease may be associated with decreased brain synthesis of norepinephrine (a neurotransmitter associated with multiple brain functions).
During this 11 week study, droxidopa will be slowly titrated up to 600 mg daily. Walking and freezing of gait will be evaluated and rated. Cognitive functions will be evaluated by a computer-based program.
- Being tested
- Droxidopa, sugar pill
- Keywords
- Parkinson's disease, Freezing of gait, Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DroxidopaDrug
Droxidopa will be supplied in 100 and 200 mg pill sizes. The proposed dosing is 100mg twice daily at baseline, then titrate to 200 mg twice daily at day 7 and then titrate to 300mg twice daily at day 14. Subjects will stay on the 600mg daily for 2 weeks. Total exposure 28 days of study drug.
sugar pillDrug
Also called placebo
Sugar pill or placebo will be supplied in pill sizes matched to droxidopa formulation. The study titration will be the same. Sugar pills will be used for 5 weeks during the study.
| Study group | Role | What they receive |
|---|---|---|
| droxidopa, then sugar pill | Other | Droxidopa will be titrated over a 2-week period up to 300 mg twice daily (600 mg total daily dose). Subjects will be titrated to highest tolerated dose and will continue on that dose for two weeks. Then, the subject will start sugar pills. Receives: Drug: Droxidopa; Drug: sugar pill |
| sugar pill, then droxidopa | Other | Subject will be be on sugar pill for 5 weeks (4 weeks of placebo treatment and one week of wash-out or sugar pills). Then, droxidopa will be titrated over 2 week period up to 300 mg twice daily (600 mg total daily dose). Subjects will be titrated to highest tolerated dose and will continue on that dose for two weeks. Receives: Drug: Droxidopa; Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in freezing of gait symptoms using Freezing of Gait Questionnaire
Evaluate the effect of droxidopa on freezing of gait symptoms using the Freezing of Gait Questionnaire completed by patients. All measures will be performed at baseline and after two and four weeks of study medication.
Measured: 4 weeks
Change from baseline in cognitive testing
Battery of cognitive testing is performed. All measures will be performed at baseline and after two and four weeks of study medication.
Measured: 4 weeks
Secondary outcomes (4)
Change in measurement of freezing of gait
Videotaped evaluations quantifying the number of episodes of freezing of gait and their severity will be rated using the Observed Freezing of Gait scale. The Timed Up and Go test will evaluate the effect of droxidopa on PD symptoms. The effect of droxidopa treatment on gait features of stride, swing time variability, and gait asymmetry will be analyzed. All measures will be performed at baseline and after two and four weeks of study medication.
Measured: 4 weeks
Change in the incidence of falls
Videotaped evaluations quantifying the number of fall episodes will be rated using the Observed Freezing of Gait scale. The Timed Up and Go test will evaluate the effect of droxidopa on PD symptoms and freezing of gait. The effect of droxidopa on falls will be analyzed using the GaitRite system.
All measures will be performed at baseline and after two and four weeks of study medication.
Measured: 4 weeks
Change in signs and symptoms of Parkinson's disease
The UPDRS (Unified Parkinson's Disease Rating Scale) will be performed at baseline and after 2 and 4 weeks on study drug for each arm.
Measured: 4 weeks
Number of participants with serious and non-serious adverse events
Safety of droxidopa will be evaluated based on the occurrence of treatment emergent adverse events with specific evaluation of blood pressure, heart rate , ECG, suicidality, and laboratory findings across the study
Measured: up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMar 2015
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter LeWitt MD, Henry Ford Health System
- Investigators
- Peter LeWitt, M.D., Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066571
- Sponsor's protocol ID
- LeWitt01
- Other IDs
- IND 119340
- Status last verified
- Nov 2016
- First submitted
- 18 Feb 2014
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Placebo-Controlled, Crossover Study to Assess Clinical Benefit and Safety of Droxidopa in the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02066571
- Acronym / sponsor ID
- LeWitt01
- Keywords
- Parkinson's disease, Freezing of gait, Gait
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Feb 2014 (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.
Since droxidopa has been approved in Japan for treating freezing of gait in Parkinson's disease patients, this is to confirm and further investigate the safety and efficacy using a similar dose. The possible beneficial effects on cognition in mildly cognitively impaired Parkinson's disease patients will also be tested, since this problem in Parkinson's disease may be associated with decreased brain synthesis of norepinephrine (a neurotransmitter associated with multiple brain functions).
During this 11 week study, droxidopa will be slowly titrated up to 600 mg daily. Walking and freezing of gait will be evaluated and rated. Cognitive functions will be evaluated by a computer-based program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| droxidopa, then sugar pill | Other | Drug: Droxidopa, Drug: sugar pillDroxidopa will be titrated over a 2-week period up to 300 mg twice daily (600 mg total daily dose). Subjects will be titrated to highest tolerated dose and will continue on that dose for two weeks. Then, the subject will start sugar pills. |
| sugar pill, then droxidopa | Other | Drug: Droxidopa, Drug: sugar pillSubject will be be on sugar pill for 5 weeks (4 weeks of placebo treatment and one week of wash-out or sugar pills). Then, droxidopa will be titrated over 2 week period up to 300 mg twice daily (600 mg total daily dose). Subjects will be titrated to highest tolerated dose and will continue on that dose for two weeks. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide written informed consent to participate in the study
- Diagnosed with probable levodopa-responsive idiopathic PD (meeting United Kingdom PD Brain Bank diagnostic criteria), and receiving levodopa therapy for this disorder. Other PD medications can also be used.
- Must have AT LEAST ONE of below two criteria:
Key exclusion criteria (23 listed)
- Taking direct acting vasoconstriction agent (i.e. ephedrine or midodrine). Subjects taking vasoconstrictor agents such as ephedrine or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit
- Taking anti-hypertensive medication for the treatment of hypertension. Anti-hypertensive medication taken at night to prevent supine hypertension will be allowed
- Changing dose or frequency of PD medication within 2 weeks of baseline
- Use of cognitive-enhancing medications (donepezil, galantamine, rivastigmine, tacrine, or memantine), catechol-O-methyltransferase inhibitors (tolcapone or entacapone), anticholinergic drugs, or antipsychotic drugs (including quetiapine or clozapine).
- Known or suspected alcohol or substance abuse within 1 year (e.g. DSM-IV definition of alcoholism)
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 |
|---|---|---|
| DroxidopaDroxidopa will be supplied in 100 and 200 mg pill sizes. The proposed dosing is 100mg twice daily at baseline, then titrate to 200 mg twice daily at day 7 and then titrate to 300mg twice daily at day 14. Subjects will stay on the 600mg daily for 2 weeks. Total exposure 28 days of study drug. | Drug | droxidopa, then sugar pill, sugar pill, then droxidopa |
| sugar pillAlso: placeboSugar pill or placebo will be supplied in pill sizes matched to droxidopa formulation. The study titration will be the same. Sugar pills will be used for 5 weeks during the study. | Drug | droxidopa, then sugar pill, sugar pill, then droxidopa |
Primary outcome
Change from baseline in freezing of gait symptoms using Freezing of Gait Questionnaire
Time frame: 4 weeks
Evaluate the effect of droxidopa on freezing of gait symptoms using the Freezing of Gait Questionnaire completed by patients. All measures will be performed at baseline and after two and four weeks of study medication.
Change from baseline in cognitive testing
Time frame: 4 weeks
Battery of cognitive testing is performed. All measures will be performed at baseline and after two and four weeks of study medication.
4 secondary outcomes
Change in measurement of freezing of gait
Time frame: 4 weeks
Change in the incidence of falls
Time frame: 4 weeks
Change in signs and symptoms of Parkinson's disease
Time frame: 4 weeks
Number of participants with serious and non-serious adverse events
Time frame: up to 11 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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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.
Peter LeWitt, M.D. principal investigator
Henry Ford Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Droxidopa and sugar pill in people with Parkinson's Disease and Freezing of Gait, run by Henry Ford Health System at 2 sites 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 23 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
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 in freezing of gait symptoms using Freezing of Gait Questionnaire (time frame: 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 3 Nov 2016.