Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Henry Ford Health System
Age
30–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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:
1. 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
2. Have a screening score between 22 and 26 (inclusive) on the Montreal Cognitive Assessment
You may not be if
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)
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
Clareo Health | Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease
