A Phase 1/2 interventional study of Cerebral Dopamine Neurotrophic Factor and Renishaw Drug Delivery System in Parkinson Disease, Movement Disorders and Neurodegenerative Diseases, sponsored by Herantis Pharma Plc.. Completed at 3 sites in 2 countries. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Herantis Pharma Plc. · Phase 1/2, Interventional, and Treatment
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Among 79 studies in Parkinson Disease with a site in Sweden — 14 open to participants now, 18 under way, none of them phase 3. Parkinson Disease · Sweden.
Among the 79 studies in Parkinson Disease with a site in Sweden, this one is the 47th largest by enrollment of the 61 interventional ones that give a count, is one of 8 that started in 2017, is one of 5 in phase 1/2, and was the 39th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →14 of the 79 studies in Parkinson Disease with a site in Sweden are open now. Recruiting first, the newest first:
Lund University · Sites in Sweden
Ages 18+
University Hospital Tuebingen · Sites in Sweden, France, Germany and 4 more countries
Ages 35–80
Navamedic AB · Sites in Sweden
Ages 30+
Karolinska Institutet · Sites in Sweden
Ages 18+
AbbVie · Sites in Sweden, Austria, Netherlands and 1 more country
Ages 18+
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 750 Parkinson Disease studies recruiting now, 312 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 190 take healthy volunteers.
This study: 35 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 15 · Phase 3 14 · Phase 4 7
First in 2002; this study’s year is marked. 8 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 89 across the 61 interventional studies, 316 across the 18 observational. Of the 57 that completed or were terminated, 20 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
43 of 79 have an industry lead sponsor. The 10 most frequent:
Herantis Pharma Plc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Herantis Pharma Plc. has 4 studies filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
5 of the studies in Parkinson Disease with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06891703AC Immune SA[18F]ACI-15916 PET in α-synucleinopathies | 2026-12 |
| NCT06901869Karolinska InstitutetPhysical Activity in Persons With Parkinson's Disease | 2026-12 |
| NCT05635409Region SkaneA Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease | 2027-01 |
| NCT07839793Navamedic ABA 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients | 2027-03-31 |
| NCT05573542Örebro University, SwedenEarly Signs of Parkinsons Disease in IBS | 2027-10 |
Add all 5 to your calendar (.ics) → With an account.
Among the 79 studies in Parkinson Disease with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study evaluates the 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). 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.
A patient's participation in the study will last for ten months and will include sixteen to seventeen visits:
Study examinations and assessments
For more information: https://treater.eu/clinical-study/
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this group will receive 6 monthly infusions of placebo/vehicle
Drug: Cerebral Dopamine Neurotrophic Factor · Device: Renishaw Drug Delivery System
Patients randomized to this group will receive 6 doses of CDNF titrated to mid-dose
Drug: Cerebral Dopamine Neurotrophic Factor · Device: Renishaw Drug Delivery System
Patients randomized to this group will receive 6 doses of CDNF titrated to high-dose
Drug: Cerebral Dopamine Neurotrophic Factor · Device: Renishaw Drug Delivery System
Repeated intracerebral infusions
Also known as: CDNF
Stereotactically implanted device
Also known as: DDS
Adverse events (AEs)
Number and severity of adverse events
Time frame: Week 15 to Week 40
Electrocardiogram (ECG)
Changes in electrical activity of heartbeat measured by electrocardiogram
Time frame: Week 15 to Week 40
Beck Depression Inventory (BDI) score
Assessment of change in depression using Beck Depression Inventory (BDI) score
Time frame: Week 15 to Week 40
Questionnaire for impulsive-compulsive disorder in Parkinson's disease rating scale (QUIP_RS)
Assessment of changes in impulsive-compulsive disorders using QUIP_RS
Time frame: Week 15 to Week 40
Montreal cognitive assessment (MoCA)
Assessment of change in cognitive domains using MoCA test
Time frame: Week 15 to Week 40
Physical examination
Changes in anatomic findings found in physical examination
Time frame: Week 15 to Week 40
Vital signs
Changes in vital signs
Time frame: Week 15 to Week 40
Clinical laboratory safety screen
Changes in clinical laboratory variables (chemistry, haematology, urinanalysis)
Time frame: Week 15 to Week 40
Formation of anti-CDNF antibodies
Change in anti-CDNF antibody concentration
Time frame: Week 15 to Week 40
Device related changes in safety measures
Occurrence of adverse device effects (ADE), for either the whole system or the individual sub systems (guide tubes/catheters, subcutaneous components, port), serious adverse device effect (SADE) including long term effects, neurological deficit (seizures), infection (local to components, in CNS), severe skin breakdown or necrosis requiring component removal life threatening or major (requiring intervention) intracerebral haemorrhage.
Time frame: Week 8 to Week 40
Device related accuracy of implantation
The accuracy of implantation of the Drug Delivery System (DDS) will be measured comparing the tip of each individual catheters defined in the plan of the surgical procedure with the position of those measured by the post-operative CT scan.
Time frame: Week 8
UPDRS (Unified Parkinson's Disease Rating Scale) Part III motor score
Changes in severity of PD (Parkinson's disease) motor symptoms assessed by UPDRS Part III motor scores
Time frame: Week 15 to Week 40
TUG (Timed Up and Go) test
Changes in mobility assessed by TUG test
Time frame: Week 15 to Week 40
UPDRS Total score (Part I-IV)
Change in severity of PD non-motor and motor symptoms assessed by UPDRS Part I-IV total scores (Parts I, II and IV in ON-state; Part III in OFF-state).
Time frame: Week 15 to Week 40
Home diary score
Change in functional status assessed by home diary score
Time frame: Week 16 to Week 24
PDQ-39 (Parkinson's Disease Questionnaire) score
Changes in health and daily activity assessed by PDQ-39 questionnaire score
Time frame: Week 15 to Week 40
change in CGI (Clinical Global Impressions) scale
• Change from baseline until end of treatment evaluation in mental status as measured by CGI scale.
Time frame: Week 16 to Week 40
Occurrence of blockage
Occurrence of blockage of implanted catheter preventing or limiting infusion assessed by measuring catheter pressure
Time frame: Week 11 to Week 36
Cessation of infusions
Cessation of infusions in an individual patient
Time frame: Week 11 to Week 36
DAT (dopamine transporter)-PET imaging
Change in caudate and putamen DAT availability using PET imaging.
Time frame: Week 14 to Week 38
alpha-synuclein levels
Changes in serum and CSF (cerebrospinal fluid) concentrations of various α-synuclein species
Time frame: Week 15 to Week 40
Distribution of CDNF
Level of distribution of CDNF in serum and Cmax of CDNF in CSF
Time frame: Week 24 and Week 36
Daily activity measurement
Change in daily activity measured by Parkinson's KinetiGraph™ (PKG™) Data Logger
Time frame: Week 16 to Week 40
Coverage of infusate
Coverage of the infusate in target anatomy assessed by MRI (Magnetic resonance imaging)
Time frame: Week 11 to Week 36
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Dec 2019, 26 months.
Of 55 phase 1/2 interventional studies under Parkinson Disease, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's 26 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Herantis Pharma Plc.