Ignite Creation Date:
2024-05-06 @ 10:34 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03295786
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2017-09-14
Brief Title:
Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinsons Disease
Sponsor:
Herantis Pharma Plc
Organization:
Herantis Pharma Plc
Study Overview
Official Title:
Phase 1-2 Randomised Double-Blind Placebo Controlled Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor CDNF Infusions Via an Investigational Drug Delivery System to Patients With Parkinsons Disease
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 evaluates the safety and tolerability of CDNF in patients with Parkinsons 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
Detailed Description:
A patients participation in the study will last for ten months and will include sixteen to seventeen visits
Screening 2 visits
Planning of surgery - Surgery implantation of drug delivery system - Post-surgery follow-up 3 visits
Test infusions with vehicle 1-2 visits
Positron emission tomography PET examinations before the first and after the last dose 2 visits
Baseline and randomisation to CDNF or placebo group 1 visit
Dosing visits CDNF or placebo 6 visits
End-of-study visit 1 visit
Study examinations and assessments
- Physical examination pulse rate blood pressure temperature body weight and height
ECG electrocardiography and blood and urine tests
HIV hepatitis B and C blood tests on first visit
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 device worn on the wrist for certain periods during the study to record movements
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
Computed tomography CT
For more information httpstreatereuclinical-study
Screening 2 visits
Planning of surgery - Surgery implantation of drug delivery system - Post-surgery follow-up 3 visits
Test infusions with vehicle 1-2 visits
Positron emission tomography PET examinations before the first and after the last dose 2 visits
Baseline and randomisation to CDNF or placebo group 1 visit
Dosing visits CDNF or placebo 6 visits
End-of-study visit 1 visit
Study examinations and assessments
- Physical examination pulse rate blood pressure temperature body weight and height
ECG electrocardiography and blood and urine tests
HIV hepatitis B and C blood tests on first visit
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 device worn on the wrist for certain periods during the study to record movements
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
Computed tomography CT
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-004175-73 | EUDRACT_NUMBER | None | None |