Studies for Parkinson's Disease Patients with Off-Time

OFF-Time - time when the medication is not working to its full potential and symptoms are not well controlled. This can be predictable such as wearing off between doses when symptoms return at the end of one dose before the next dose is taken; or this can be unpredictable where medication suddenly loses its effect or when a particular dose of medication does not take effect.


Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients Using Levodopa (TOZ-PD)

Purpose: Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).

Duration: Part A - up to 30 weeks. After completion of Part A, patients will continue in Part B for an additional 56 weeks.

Study design: Randomized, double-blind, placebo-controled

Inclusion Criteria:
30 years to 80 years
Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain Bank Diagnostic criteria
Minimum of 3 years since diagnosis
Good response to levodopa
Stable regimen of anti-PD medications
Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months
Patient has documented a minimum amount of Off time.

Exclusion Criteria:
Previous tozadenant study participation
Current or recent participation in another study.
Secondary or atypical parkinsonism
Neurosurgical intervention for PD
Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPATM/Duodopa®
Untreated or uncontrolled hyperthyroidism or hypothyroidism
Current episode of major depression (stable treatment for depression is permitted).
Recent suicide attempt or suicidal ideation
History of hepatitis or cholangitis


A Study to Assess the Efficacy and Safety of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients (Accordance)

Purpose: The purpose of this study is to determine whether the gastric retentive Accordion PillTM Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.

Study design: Randomized, double-blind, double-dummy

Study duration: The study will have 2 open label periods of 6 weeks each prior to the double blind period. In the open label periods all patients will be stabilized on the active comparator Sinemet® and on AP-CD/LD. The double blind active period will be 13 weeks long

Official title: Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients

Inclusion criteria:
Men or women between 35 and 85 years of age, inclusive, at initial screening assessment.
Diagnosed with idiopathic Parkinson's disease.
Has a good response to levodopa in the opinion of the investigator, and is taking at least 4 doses of levodopa containing medication per day.
Total LD daily dose of 400 to 1300 mg in at least four divided doses, prior to initial screening assessment.
Able to complete a Hauser home diary and can tell the difference between "On and Off" time.

Exclusion Criteria:
Participation in another drug clinical trial within 28 days prior to initial screening assessment.
Significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the investigator, contraindicates his/her participation.
Treatment with COMT inhibitors during the last 14 days prior to initial screening assessment.
Neurosurgical treatment for Parkinson's Disease.
History of alcohol or substance abuse within the past 2 years.
Unable to swallow large pills (e.g., large vitamin pills).
History of melanoma or suspicious current skin lesion.
Chronic wide-angle glaucoma.

An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease

Purpose: A 24-week, prospective, multi-center, open-label, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to evaluate the long-term safety, tolerability and efficacy of APL-130277.

Study design: Open label

Duration: 24 weeks

Official title:  An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

Inclusion criteria:
Male or female ≥ 18 years of age.
Clinical diagnosis of Idiopathic PD
Receiving stable doses of L-Dopa/carbidopa (immediate or chronic release) administered at least 4 times per day OR RytaryTM administered 3 times per day, for at least 4 weeks before the initial Screening Visit (SV1). 
Patients must experience at least one well defined "OFF" episode per day

Exclusion criteria:
Previous treatment with any of the following: a neurosurgical procedure for PD or Duodopa/Duopa
Treatment with any form of s.c. apomorphine within 7 days prior to the initial Screening Visit (SV1). 
Currently taking selective 5HT3 antagonists (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine and clozapine) or dopamine depleting agents.
Drug or alcohol dependency in the past 12 months.
History of malignant melanoma.
Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
Major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
History of clinically significant hallucinations during the past 6 months.
History of clinically significant impulse control disorder(s).
Dementia that precludes providing informed consent or would interfere with participation in the study.

Infusion of Apomorphine: Long-term Safety Study (INFUS-ON)

A Phase 3, multicenter, open-label, safety and efficacy study of continuous infusion apomorphine in subjects with advanced Parkinson's Disease (PD) who are unable to achieve adequate control despite optimized noninvasive therapy.

52 weeks

Study design: 
Open Label

Inclusion Criteria:
30 to 80 years
Advanced idiopathic PD consistent with UK brain bank criteria
Overall control is unsatisfactory in the opinion of the Investigator and subject despite optimal treatment with noninvasive therapy, with the exception of current APOKYN users, which will be restricted to no more than 25% of total enrolled subjects

Exclusion Criteria:
History of deep brain stimulation, levodopa-carbidopa intestinal gel surgery, or any other surgical intervention for the treatment of Parkinson's disease at study entry or at any time during a subject's participation in the study
History of hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN PFS, including sodium metabisulfite
Recent history of (within past 12 months), or strong potential for, alcohol or substance abuse
Lifetime history of impulsive/compulsive behaviors primarily associated with the use of dopamine agonists
History of previously treated or current diagnosis of malignant melanoma

Last modified: Mar 16, 2017