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

 

Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes (SPAN-PD TM)

Purpose:
Evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena)

Duration: 12 Weeks

Study design: Randomized, Double Blind

Inclusion Criteria:
30 years - 80 years
Require levodopa-containing medication regimen at least 4 times during the waking day;
Are on stable PD medication regimen;
Total daily LD dose ≤1600 mg/day;

Exclusion Criteria:
Previous surgery for PD or plan to have stereotactic surgery during the study period;
History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
Any contraindication to performing routine spirometry.

 

A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease (KW-6002)

Purpose: To assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease who are already on Levodopa/Carbidopa or Levodopa/Benserazide therapy.

Duration: 12 weeks

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

Inclusion criteria:
30 years of age or older.
On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit.
Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization.
Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization.
Documented end-of-dose wearing-off and levodopa-induced dyskinesia.
Have an average of two hours of OFF time per day.

Exclusion Criteria:

Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
Subject who have had neurosurgical operation for PD.
Subjects who smoke > 5 cigarettes/day 

 

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.

Last modified: Feb 22, 2016
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