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

 

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

Purpose:
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.

Duration:
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

 

Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease (INTREPID)

Purpose: The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

Duration: 52 weeks

Study Design: Randomized, Double Blind, Active Comparator (Medium continuous dose of stimulation), Sham Comparator (Low intermittent dose of stimulation)

Inclusion Criteria:
Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.

Exclusion Criteria:
Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
Any other active implanted devices including neurostimulators and /or drug delivery pumps
Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.

Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations

Purpose: The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.

Study design: Double blind, randomized, placebo-controlled

Study duration: Approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period

Official Title: A 15-week, Phase 2, Double Blind, Randomized, Placebo-controlled, Dose Ranging Study To Investigate The Efficacy, Safety And Tolerability Of Pf-06649751 In Subjects With Motor Fluctuations Due To Parkinson's Disease

Inclusion Criteria
Females of non-childbearing potential and/or male subjects between the ages of 45 and 85 years, inclusive.
Clinical diagnosis of Parkinson's disease.

Exclusion Criteria:
History or presence of atypical Parkinsonian syndrome.
History of surgical intervention for Parkinson's disease.
Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
Any condition possibly affecting drug absorption.
Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.  

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.

Last modified: Aug 02, 2016
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