Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

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.
Have a screening score between 22 and 26 (inclusive) on the Montreal Cognitive Assessment
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
...
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.
Have a screening score between 22 and 26 (inclusive) on the Montreal Cognitive Assessment
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
Provide written informed consent to participate in the study

Exclusion Criteria

Known or suspected malignancy (other than basal cell carcinoma)
Known or suspected alcohol or substance abuse within 1 year (e.g. DSM-IV definition of alcoholism)
Known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator's opinion, affect the absorption of study drug
...
Known or suspected malignancy (other than basal cell carcinoma)
Known or suspected alcohol or substance abuse within 1 year (e.g. DSM-IV definition of alcoholism)
Known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator's opinion, affect the absorption of study drug
Past or current history of chronic severe hypertension (with repeated findings of BP 150/90 mmHg in the supine or standing position)
Taking anti-hypertensive medication for the treatment of hypertension. Anti-hypertensive medication taken at night to prevent supine hypertension will be allowed
Symptomatic coronary artery disease, severe congestive heart failure (NYHA Class 3 or 4)
Any major surgical procedure within 30 days of the baseline visit
A history of closed angle glaucoma;
Congestive heart failure (NYHA Class 3 or 4)
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
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)
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
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).
Unable to remain off any effective Freezing of Gait medications for 12 hrs prior to Evaluation visits)
Findings from suicidality screening that are compatible with risk for suicide
History of myocardial infarction or unstable angina
In the investigator's opinion, clinically significant abnormalities on clinical examination or laboratory testing that should preclude the subject from this trial.
In the investigator's opinion, any other significant systemic illness
Changing dose or frequency of PD medication within 2 weeks of baseline
Currently receiving any investigational drug or have received an investigational drug within 30 days of the baseline visit
Women who are pregnant, lactating, or plan to become pregnant during the course of this study
Diabetes insipidus, insulin-dependent diabetes mellitus, or diabetic neuropathy
Women of child bearing potential who are not using two methods of contraception (at least one barrier, i.e. condom) with their partner.

Summary

Conditions
  • Cognitive Ability General
  • Freezing of Gait
  • Parkinson's Disease
  • Cognitive Ability, General
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 30 years and 125 years
Gender
Both males and females

Inclusion Criteria

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.
Have a screening score between 22 and 26 (inclusive) on the Montreal Cognitive Assessment
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
...
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.
Have a screening score between 22 and 26 (inclusive) on the Montreal Cognitive Assessment
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
Provide written informed consent to participate in the study

Exclusion Criteria

Known or suspected malignancy (other than basal cell carcinoma)
Known or suspected alcohol or substance abuse within 1 year (e.g. DSM-IV definition of alcoholism)
Known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator's opinion, affect the absorption of study drug
...
Known or suspected malignancy (other than basal cell carcinoma)
Known or suspected alcohol or substance abuse within 1 year (e.g. DSM-IV definition of alcoholism)
Known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator's opinion, affect the absorption of study drug
Past or current history of chronic severe hypertension (with repeated findings of BP 150/90 mmHg in the supine or standing position)
Taking anti-hypertensive medication for the treatment of hypertension. Anti-hypertensive medication taken at night to prevent supine hypertension will be allowed
Symptomatic coronary artery disease, severe congestive heart failure (NYHA Class 3 or 4)
Any major surgical procedure within 30 days of the baseline visit
A history of closed angle glaucoma;
Congestive heart failure (NYHA Class 3 or 4)
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
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)
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
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).
Unable to remain off any effective Freezing of Gait medications for 12 hrs prior to Evaluation visits)
Findings from suicidality screening that are compatible with risk for suicide
History of myocardial infarction or unstable angina
In the investigator's opinion, clinically significant abnormalities on clinical examination or laboratory testing that should preclude the subject from this trial.
In the investigator's opinion, any other significant systemic illness
Changing dose or frequency of PD medication within 2 weeks of baseline
Currently receiving any investigational drug or have received an investigational drug within 30 days of the baseline visit
Women who are pregnant, lactating, or plan to become pregnant during the course of this study
Diabetes insipidus, insulin-dependent diabetes mellitus, or diabetic neuropathy
Women of child bearing potential who are not using two methods of contraception (at least one barrier, i.e. condom) with their partner.

Tracking Information

NCT #
NCT02066571
Collaborators
Not Provided
Investigators
  • Principal Investigator: Peter LeWitt, M.D. Henry Ford Health System
  • Peter LeWitt, M.D. Henry Ford Health System