Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03775538
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2018-10-11
Brief Title:
Safety of CDNF by Brain Infusion in Patients With Parkinsons Disease Extension to HP-CD-CL-2002 Clinical Study
Sponsor:
Herantis Pharma Plc
Organization:
Herantis Pharma Plc
Study Overview
Official Title:
A Randomised Double-Blind Multi-centre Active Treatment Extension and Safety Study for Patients With Idiopathic Parkinsons Disease PD Who Previously Completed the CDNFDDS Main Study HP-CD-CL-2002
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an extension to the HP-CD-CL-2002 clinical study It evaluates the long-term safety and tolerability of CDNF in patients with Parkinsons disease when dosed directly into the brain using an implanted investigational drug delivery system DDS Long-term safety of the DDS is also being evaluated All patients will receive monthly infusions of either mid- or high-dose of CDNF for a period of 6 months
Detailed Description:
A patients participation in the study will last for six months and will include nine visits
Screening 1 visit same as HP-CD-CL-2002 End-of-Study visit Dosing visits CDNF 6 visits DAT-PET 1 visit End-of-study visit 1 visit
Study examinations and assessments
Physical examination pulse rate blood pressure temperature body weight and height body mass index BMI neurological exam
ECG electrocardiography and blood and urine tests
Pregnancy tests for women of childbearing age
Completion of a patient diary to record mobility and time asleep
Parkinsons Kinetigraph PKGTM Data Logger a watch-type movement recording device
Questionnaires rating scales and forms quality of life mood memory impulse control mental health
Assessment of the port and the skin around the port
Cerebrospinal fluid sampling by lumbar puncture
Magnetic resonance imaging MRI
Positron emission tomography scans PET
For more information httpstreatereuclinical-study
Screening 1 visit same as HP-CD-CL-2002 End-of-Study visit Dosing visits CDNF 6 visits DAT-PET 1 visit End-of-study visit 1 visit
Study examinations and assessments
Physical examination pulse rate blood pressure temperature body weight and height body mass index BMI neurological exam
ECG electrocardiography and blood and urine tests
Pregnancy tests for women of childbearing age
Completion of a patient diary to record mobility and time asleep
Parkinsons Kinetigraph PKGTM Data Logger a watch-type movement recording device
Questionnaires rating scales and forms quality of life mood memory impulse control mental health
Assessment of the port and the skin around the port
Cerebrospinal fluid sampling by lumbar puncture
Magnetic resonance imaging MRI
Positron emission tomography scans PET
For more information httpstreatereuclinical-study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None