Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study

• Status: Completed
• Trial end date: 2020-07-08
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herantis Pharma Plc.
• Collaborator: Renishaw plc.
• Treatments: Dopamine

Criteria

Inclusion Criteria:

1. Completion of 6 months treatment period in the Main study (HP-CD-CL-2002) including End-of-Study assessment

2. 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.

3. At least one functioning catheter in each putamen

4. Provision of informed consent

Exclusion Criteria:

1. Drug-resistant rest tremor, severe dyskinesia or severe head tremor, which could interfere with treatment infusions

2. Significant neurological disorder other than PD including clinically significant head trauma, cerebrovascular disease, epilepsy, CSF shunt or other implanted central nervous system device

3. Changes in pathology which give rise to safety concern such as sequelae from catheter implantation, clinically significant intracerebral trauma, oedema, haemorrhage, or infection

4. Current psychosis requiring therapy

5. Presence of clinically significant impulse control disorder by a positive screen on the QUIP-RS questionnaire score >20, or, presence of dopamine dysregulation syndrome

6. 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

7. Medical conditions, which might impair outcome measure assessments or safety measures

8. Impaired renal function

9. Concomitant treatment with neuroleptics or antipsychotic medication prescribed for treatment of current psychosis, central dopamine blockers or tricyclic antidepressants