[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

858-617-7744

Email address

cechen@neurocrine.com

Condition

Parkinson Disease,Parkinson's Disease

Treatment type

Interventional

Investigational product

VY-AADC02

Phase

Phase 2

Sponsor

Neurocrine Biosciences

ClinicalTrials.gov identifier

NCT03562494

Study number

PD-1105

Understanding clinical trials

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About the study

The objectives of this study are to assess the efficacy, safety and tolerability of VY-AADC02 in Patients with Parkinson's Disease with Motor Fluctuations.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. inclusive) 2. Diagnosis of PD, consistent with United Kingdom Brain Bank Criteria 3. Motor responsiveness to dopaminergic therapy, demonstrated by improvement in MDS-UPDRS III score 4. Disease duration from diagnosis of ≥4 years 5. An average of ≥3 hours of OFF time (ie, periods of insufficient control of motor PD
  2. symptoms) per day over 3 consecutive days as confirmed by the PD Diary 6. A stable, optimal regimen of Parkinson's medications including levodopa for at least weeks prior to screening evaluation. Participants must have a minimum duration of levodopa treatment of ≥1 year 7. In the judgment of the Investigator, stable Parkinson's features and symptoms for at least 4 weeks prior to screening evaluation 8. Agrees to defer any elective neurological surgery, including deep brain stimulation or ablation procedure for PD, levodopa or apomorphine infusion, or the addition of new dopaminergic formulations until after the study is completed, if medically appropriate 9. Ability to travel to study visits Key
Exclusion criteria
  1. depression) within 1 year of screening 4. Brain imaging abnormalities in the striatum or other regions that would substantially increase risk of surgery 5. Contraindication to MRI and/or gadolinium-based contrast agents 6. Prior brain surgery, infusion therapies or planned treatments that could complicate the study procedure or negatively impact study evaluations as determined from participant interview, screening MRI, or medical records 7. History of malignancy other than treated carcinoma in situ within 3 years of screening evaluation 8. Prior gene transfer, current treatment with any investigational agent (drug or
  2. device) within 2 months of screening evaluation, or participation or plans to participate in another research study 9. Severe, biphasic and/or uncontrolled dyskinesia 10. Disabling or uncontrolled impulse control disorders

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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