[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

+358401585669

Email address

sigrid.booms@herantis.com

Condition

Brain Diseases,Movement Disorders,Nervous System Diseases,Neurodegenerative Diseases,Parkinson Disease

Treatment type

Interventional

Investigational product

Renishaw Drug Delivery System

Phase

Phase 1/Phase 2

Sponsor

Herantis Pharma Plc.

ClinicalTrials.gov identifier

NCT03295786

Study number

HP-CD-CL-2002

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About the study

This study evaluates the safety and tolerability of CDNF in patients with Parkinson's disease, when dosed directly into the brain using an implanted investigational drug delivery system (DDS). Safety and accuracy of the DDS is also being evaluated. One-third of the patients will receive monthly infusions with placebo and two-third of the patients will receive monthly infusions with either mid- or high-doses of CDNF for a period of 6 months.

Who can take part?

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

Inclusion criteria
  1. inclusive) 3. Age 35-75 years (
  2. inclusive) 4. Presence of motor fluctuations. 5. At least 5 daily doses of levodopa 6. Ability to reliably distinguish motor states and accurately complete fluctuation diaries 7. UPDRS motor score (part
  3. III) in a practically defined OFF-state between 25-50 (
  4. inclusive) 8. Hoehn and Yahr ≤ stage III in the OFF-state 9. Responsiveness to levodopa 10. No change in anti-parkinsonian medication for 6 weeks before screening 11. Provision of Informed Consent
Exclusion criteria
  1. RS) score > 20), or, presence of dopamine dysregulation syndrome. 9. MoCA score < 24. 10. Use within 3 months of planned catheter insertion of concomitant medications known to affect PD symptoms other than prescribed PD therapy. 11. Any medical condition, which might impair outcome measure assessments or safety measures including ability to undergo MRI or DAT-PET. 12. Hypersensitivity or allergy to gadolinium or to any of excipients of macrocyclic GBCA used for the surgical planning MRI. 13. Screening and/or planning MRI demonstrating any abnormality, which would suggest an alternative cause for patient's parkinsonism or preclude neurosurgery. 14. Any medical condition that would put the patient at undue risk from surgical treatment or chronic implants including but not limited to bleeding disorders, chronic infections, or immunosuppressive illness 15. History within the last 5 years of cancer with the exception of basal cell carcinoma of the skin 16. History of drug or alcohol abuse within 2 years of screening 17. Use of any investigational drug or device within 90 days of screening 18. Active breastfeeding

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

Study locations

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How to apply

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