Status:
COMPLETED
Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study
Lead Sponsor:
Herantis Pharma Plc.
Collaborating Sponsors:
Renishaw plc.
Conditions:
Parkinson Disease
Movement Disorders
Eligibility:
All Genders
35-75 years
Phase:
PHASE1
PHASE2
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 Parkinson's disease when dosed directly into the brain using...
Detailed Description
A patient's 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 v...
Eligibility Criteria
Inclusion
- Completion of 6 months treatment period in the Main study (HP-CD-CL-2002) including End-of-Study assessment
- Negative pregnancy test at study entry for females of childbearing potential. Willingness of using a highly effective form of contraception until 30 days after end of study. Males: willingness to use condom and not to donate sperm for 3 months following DAT-PET. Willingness of female partners of male study participants to use highly effective form of contraception until 30 days after their male partner's end of the study.
- At least one functioning catheter in each putamen
- Provision of informed consent
Exclusion
- Drug-resistant rest tremor, severe dyskinesia or severe head tremor, which could interfere with treatment infusions
- Significant neurological disorder other than PD including clinically significant head trauma, cerebrovascular disease, epilepsy, CSF shunt or other implanted central nervous system device
- Changes in pathology which give rise to safety concern such as sequelae from catheter implantation, clinically significant intracerebral trauma, oedema, haemorrhage, or infection
- Current psychosis requiring therapy
- Presence of clinically significant impulse control disorder by a positive screen on the QUIP-RS questionnaire score \>20, or, presence of dopamine dysregulation syndrome
- An unresolved intolerable adverse event or adverse device event in study HP-CD-CL-2002, which is not expected to resolve or cease to an acceptable level of intensity within reasonable time
- Medical conditions, which might impair outcome measure assessments or safety measures
- Impaired renal function
- Concomitant treatment with neuroleptics or antipsychotic medication prescribed for treatment of current psychosis, central dopamine blockers or tricyclic antidepressants
Key Trial Info
Start Date :
July 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03775538
Start Date
July 5 2018
End Date
July 8 2020
Last Update
August 12 2020
Active Locations (3)
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1
Helsinki University Hospital
Helsinki, Finland, 00029
2
Skåne University Hospital
Lund, Sweden, 221 85
3
Karolinska University Hospital
Stockholm, Sweden, 14186