An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease.
- Conditions
- Idiopathic Parkinson's DiseaseMedDRA version: 21.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-000346-19-FI
- Lead Sponsor
- Herantis Pharma Plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
1. Completion of the 6 months treatment period in the Main study (HP-CD-CL-2002), including End-of-Study assessment at Visit 17 (Week 24).
2. Females of childbearing potential must have a negative pregnancy test at study entry and be willing to use a highly effective form of contraception until 30 days after the end of the study (hormonal contraception associated with inhibition of ovulation, IUD, IUS, bilateral tubal occlusion, vasectomised partner or sexual abstinence). Males (non-vasectomised) must be willing to use condom during intercourse and do not donate sperms for three months following each DAT-PET scan. Female partners of childbearing potential should be willing to use a highly effective form of contraception until 30 days after their male partner’s end of the study.
3. At least one functioning catheter tip in each putamen.
4. Provision of informed consent. The patient is judged by the investigator to be alert and oriented to person, place, time and situation when giving the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9
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 (CNS) 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. Brief episodes of hallucinations, disorientation or confusion are not exclusionary.
5. Presence of clinically significant impulse control disorder by a positive screen on the questionnaire for impulsive-compulsive disorders in Parkinson’s Disease (QUIP-RS) score >20, or, presence of dopamine dysregulation syndrome.
6. Any unresolved intolerable adverse events or adverse device events in study HP-CD-CL-2002, which are not expected to resolve or cease to an acceptable level of intensity within reasonable time. This includes any Serious Adverse Event (SAE) of at least Grade 3 (severe) in severity, judged to be possibly, probably or definitely related to study treatment.
7. Any medical condition, which might impair outcome measure assessments or safety measures including ability to undergo MRI or DAT-PET.
8. Impaired renal function. Estimated Glomerular Filtration rate (eGFR) < 30 mL/min/1.73 m2 .
9. Concomitant treatment with neuroleptics or antipsychotic medication prescribed for treatment of current psychosis, central dopamine blockers or tricyclic antidepressants. Low dose quetiapine
and similar medications prescribed for Parkinson’s disease treatment are not exclusionary.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method