The purpose of this study is to evaluate the safety and effectiveness of daxibotulinumtoxinA for injection (a new investigational study drug) compared to placebo in the treatment of cervical dystonia (CD). DaxibotulinumtoxinA for injection is composed of purified botulinum toxin type A, formulated with a small protein RTP004, and will be used for injection. Placebo means it doesn't contain botulinum toxin type A.
If you are eligible and choose to be in the study, the dose of study drug you receive will depend on the group that you will be put into after randomization at the time of your entry.
You will be assigned, by chance, to 1 of the 3 groups below:
? Group 1: High-dose (250 Units of daxibotulinumtoxinA for injection)
? Group 2: Low-dose (125 Units of daxibotulinumtoxinA for injection)
? Group 3: Placebo (a substance that looks like daxibotulinumtoxinA for injection but has no drug in it)
Study lasts aproximately 39 weeks, including 3 weeks of screening. You will come to the study center up to 12 times during the research study.
The study is being done at approximately 80 sites. Approximately 300 people will take part study-wide and 4 will take part at this institution.
This study will allow evaluation of long-term safety and clinical effects as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 (?core study', a Phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase III study to assess the safety and efficacy of AP-CD/LD versus IR CD/LD in fluctuating PD patients).
This study will assess the effectiveness, safety and tolerability of Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) compared to Immediate Release Carbidopa/Levodopa (IR CD/LD) (Sinemet) in patients with fluctuating Parkinson's disease (PD).
This study will examine changes in brain architecture that are associated with vascular parkinsonism, in comparison to Parkinson's disease. We will do this by using advanced imaging techniques to compare brain structure between subjects with vascular parkinsonism and Parkinson's disease.
This is a prospective, multi-center, open-label, Phase 3 study in Levodopa responsive PD patients with motor fluctuations, designed to evaluate the long-term safety, tolerability and efficacy of APL-130277. APL-130277 is being evaluated as a "rescue" treatment for OFF episodes.
The overall number of subjects is not pre-specified as this is an extension
Patients who have completed any of the following studies: CTH-201,
CTH-203, CTH-300, CTH-301, or CTH-302 will be eligible to enroll into
this study. In addition, approximately one hundred (100) de novo patients
will also be enrolled.