Gait Disorders, NeurologicPhase 1/2NCT01331122
Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease
A Phase 1/2 study testing droxidopa in people with Gait Disorders, Neurologic, run by Chelsea Therapeutics at 2 sites in 2 countries.
Trial summary
Freezing of Gait (FoG) is a class of symptoms that occur in Parkinson's patients. Also called motor blocks, FoG is characterized by a sudden inability to move the lower extremities which usually lasts less than 10 seconds. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Gait Disorders, Neurologic
- What is being tested?
- droxidopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, aged at least 30 years;
- Diagnosed with probable levodopa-responsive idiopathic Parkinson's Disease , and receiving levodopa. Other Parkinson's Disease medications can also be used.
- At least 3 months incidence of typical freezing of gait (FOG) symptoms, occurring while levodopa is otherwise providing an "on" mobility state (including at least one of the following FOG 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).
- Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care
- On a stable dose of carbidopa, alone or with other Parkinson's medication, providing a range of carbidopa between 100mg and 400mg daily
Who cannot join
- Taking direct acting vasoconstricting agent (i.e. ephedrine or midodrine). Patients 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 more than one anti-hypertensive medication for the treatment of high blood pressure. Short acting anti-hypertensive medication taken at night to prevent supine hypertension will be allowed.
- Have changed dose or frequency of Parkinson's medication within 2 weeks of baseline
- Known or suspected alcohol or substance abuse within 1 year
- Sustained hypertension (BP greater than 140/90 mmHg in the sitting position)
- Symptomatic coronary artery disease, severe congestive heart failure
Show all 21Show fewer
- Women who are pregnant, lactating, or plan to become pregnant during the course of this study;
- Women of child bearing potential (WOCP) who are not using two methods of contraception (at least one barrier: i.e. condom) with their partner.
- Male patients who are sexually active with a woman of child bearing potential (WOCP) and not using two methods of contraception (at least one barrier: i.e. condom)
- Untreated closed angle glaucoma, or treated closed angle glaucoma that in the opinion of an ophthalmologist would cause increased risk to the patient;
- Active (last 6 months) atrial fibrillation or, in the investigator's opinion, any other significant cardiac arrhythmia that should preclude the patient from this trial;
- History of myocardial infarction or unstable angina
- 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 patient from this trial;
- Patient has only lower body Parkinson's Disease
- In the investigators opinion, freezing of gait is attributable to previous stroke
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Canada1 site
University of Alberta, Movement Disorders Clinic Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
About this study
Official title: A Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's Disease
Freezing of Gait (FoG) is a class of symptoms that occur in Parkinson's patients. Also called motor blocks, FoG is characterized by a sudden inability to move the lower extremities which usually lasts less than 10 seconds. The exact pathophysiology of FoG is poorly understood, but treatment with levodopa appears to improve FoG observed in the off-state. As Parkinson's patients progress in severity, FoG in the on-state can increase in frequency and appears to be resistant to dopaminergic therapies. There is additional evidence that norepinephrine as well as dopaminergic systems may be involved in FoG.
Droxidopa has has been approved for use in Japan since 1989 for treatment of frozen gait or dizziness associated with Parkinson's Disease. This study is to further explore the safety and efficacy of droxidopa in this indication.
- Conditions
- Gait Disorders, Neurologic
- Being tested
- droxidopa
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
droxidopaDrug
Also called Northera, SM-5688, L-DOPS, L-threo-dihydroxyphenylserine
Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes two crossover periods of up to a 2 week titration period followed by a 4 week treatment period,with a washout between crossover periods.
| Study group | Role | What they receive |
|---|---|---|
| droxidopa | Experimental | Northera (2R,3S)-2-amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid L-DOPS L-threo-dihydroxyphenylserine Droxidopa SM-5688 Receives: Drug: droxidopa |
| placebo | Placebo comparator | placebo Receives: Drug: droxidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of droxidopa as measured by the incidence, relatedness, and severity of adverse events.
Measured: 18 Weeks
Secondary outcomes (3)
Evaluate the effect of droxidopa on freezing of gait symptoms using the Freezing of Gait Questionnaire
Measured: 18 Weeks
Evaluate the efficacy of droxidopa in the treatment of freezing of gait by using the Observed Freezing of Gait Rating (OFGR) scale
Measured: 18 Weeks
Evaluate the effect of droxidopa on signs and symptoms associated with Parkinson's Disease utilizing the composite scores of the Unified Parkinson's Disease Rating Scale
Measured: 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startApr 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Never initiated. Withdrawn by sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter A LeWitt, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331122
- Sponsor's protocol ID
- Droxidopa FOG201
- Status last verified
- Mar 2013
- First submitted
- 13 Oct 2010
- Last updated
- 29 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01331122
- Acronym / sponsor ID
- Droxidopa FOG201
- Conditions
- Gait Disorders, Neurologic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never initiated. Withdrawn by sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chelsea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Apr 2011 (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.
Freezing of Gait (FoG) is a class of symptoms that occur in Parkinson's patients. Also called motor blocks, FoG is characterized by a sudden inability to move the lower extremities which usually lasts less than 10 seconds. The exact pathophysiology of FoG is poorly understood, but treatment with levodopa appears to improve FoG observed in the off-state. As Parkinson's patients progress in severity, FoG in the on-state can increase in frequency and appears to be resistant to dopaminergic therapies. There is additional evidence that norepinephrine as well as dopaminergic systems may be involved in FoG.
Droxidopa has has been approved for use in Japan since 1989 for treatment of frozen gait or dizziness associated with Parkinson's Disease. This study is to further explore the safety and efficacy of droxidopa in this indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| droxidopa | Experimental | Drug: droxidopaNorthera (2R,3S)-2-amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid L-DOPS L-threo-dihydroxyphenylserine Droxidopa SM-5688 |
| placebo | Placebo comparator | Drug: droxidopaplacebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients, aged at least 30 years;
- Diagnosed with probable levodopa-responsive idiopathic Parkinson's Disease , and receiving levodopa. Other Parkinson's Disease medications can also be used.
- At least 3 months incidence of typical freezing of gait (FOG) symptoms, occurring while levodopa is otherwise providing an "on" mobility state (including at least one of the following FOG 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).
- Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care
- On a stable dose of carbidopa, alone or with other Parkinson's medication, providing a range of carbidopa between 100mg and 400mg daily
Key exclusion criteria (21 listed)
- Taking direct acting vasoconstricting agent (i.e. ephedrine or midodrine). Patients 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 more than one anti-hypertensive medication for the treatment of high blood pressure. Short acting anti-hypertensive medication taken at night to prevent supine hypertension will be allowed.
- Have changed dose or frequency of Parkinson's medication within 2 weeks of baseline
- Known or suspected alcohol or substance abuse within 1 year
- Sustained hypertension (BP greater than 140/90 mmHg in the sitting position)
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 |
|---|---|---|
| droxidopaAlso: Northera, SM-5688, L-DOPS, L-threo-dihydroxyphenylserineOral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes two crossover periods of up to a 2 week titration period followed by a 4 week treatment period,with a washout between crossover periods. | Drug | droxidopa, placebo |
Primary outcome
Evaluate the safety of droxidopa as measured by the incidence, relatedness, and severity of adverse events.
Time frame: 18 Weeks
3 secondary outcomes
Evaluate the effect of droxidopa on freezing of gait symptoms using the Freezing of Gait Questionnaire
Time frame: 18 Weeks
Evaluate the efficacy of droxidopa in the treatment of freezing of gait by using the Observed Freezing of Gait Rating (OFGR) scale
Time frame: 18 Weeks
Evaluate the effect of droxidopa on signs and symptoms associated with Parkinson's Disease utilizing the composite scores of the Unified Parkinson's Disease Rating Scale
Time frame: 18 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
Related trials for Gait Disorders, Neurologic
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
Active, not recruiting
Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia
Hereditary Spastic Paraplegia
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Not yet recruiting
Effects of Jaw Clenching on Gait and Mobility in Stroke
Stroke
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 A LeWitt, MD principal investigator
Henry Ford Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing droxidopa in people with Gait Disorders, Neurologic, run by Chelsea Therapeutics at 2 sites in 2 countries.
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 21 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: withdrawn, as of the sponsor's last update on 29 Mar 2013. 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, Canada. 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 combined 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the safety of droxidopa as measured by the incidence, relatedness, and severity of adverse events. (time frame: 18 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 29 Mar 2013.