Parkinson DiseasePhase 1/2NCT04228653
Long-Term Follow-up Safety After DDS Implantation With/Without CDNF Infusions
A Phase 1/2 study testing Renishaw Drug Delivery System in people with Parkinson Disease and Movement Disorders, run by Renishaw at 3 sites in 2 countries.
Trial summary
This study is a follow up to the HP-CD-CL-2002 clinical study. It evaluates the long-term safety in patients with Parkinson's disease after implantation of an investigational drug delivery system (DDS) with or without infusions of CDNF. All patients will have at least the port explanted. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Parkinson Disease, Movement Disorders, Neuro-Degenerative Disease
- What is being tested?
- Renishaw Drug Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 20 Mar 2019to 20 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of visit 4 (implantation of DDS) within main study HP-CD-CL-2002.
- Patients who:
- Discontinued main study after visit 4 of main study or discontinued extension study.
- Received 6 doses in main study but didn't participate in extension study.
- Received 12 doses including extension study.
- Provision of informed consent.
Who cannot join
- None
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sweden2 sites
Skåne University Hospital
Lund, 221 85
Karolinksa University Hospital
Stockholm, 14186
About this study
Official title: A Long-Term Follow-up Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Implanted With the DDS and/or Who Received Treatment in the Main Study and/or Extension Study
This study is a follow up to the HP-CD-CL-2002 clinical study. It evaluates the long-term safety in patients with Parkinson's disease after implantation of an investigational drug delivery system (DDS) with or without infusions of CDNF. All patients will have at least the port explanted.
Read the detailed description
A patients participation in the study will last for up to 4 years and will include up to nine visits:
- Screening (1 visit, same as HP-CD-CL-2003 End-of-Study visit)
- Pre-surgery / explantation surgery / post-surgery (3 visits)
- Safety (4 visits)
- DAT-PET (Dopamine Transporter - Positron Emission Tomography) examination (1 visit)
- End-of-study visit (1 visit)
Study examinations and assessments:
- Physical examination: pulse rate, blood pressure, temperature, body weight and height, body mass index (BMI), neurological exam
- ECG (electrocardiography) and blood and urine tests
- Pregnancy tests for women of childbearing age
- Completion of a patient diary to record mobility and time asleep
- Parkinson's Kinetigraph (PKGTM) Data Logger: a watch-type movement recording device
- Questionnaires, rating scales and forms: quality of life, mood, memory, impulse control, mental health.
- Magnetic resonance imaging (MRI)
- Positron emission tomography scans (PET)
- Skin condition over any remaining implanted subcutaneous portion of the device.
- Skin healing after port / device removal.
For more information: https://treater.eu/clinical-study/
- Conditions
- Parkinson Disease, Movement Disorders, Neuro-Degenerative Disease, Nervous System Diseases, Brain Diseases
- Being tested
- Renishaw Drug Delivery System
- Keywords
- Parkinson, CDNF, Drug Delivery System, Intracerebral, Parkinson Disease, Nervous System Disease, Movement Disorders, Brain Diseases, Neurodegenerative Diseases, Parkinsonian Disorders, Basal Ganglia Diseases, Central Nervous System Diseases, Dopamine, Cardiotonic Agents, Sympathomimetrics, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Dopamine Agents, Neurotransmitter Agents
- Medical subject headings
- Parkinson Disease, Movement Disorders, Nervous System Diseases, Brain Diseases, Neurodegenerative Diseases, Parkinsonian Disorders, Basal Ganglia Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renishaw Drug Delivery SystemDevice
Device that allows pharmaceuticals to be delivered into the brain is to be assessed over a period of time to inform of the long term safety of the implanted device.
| Study group | Role | What they receive |
|---|---|---|
| No Arm | Experimental | As this is the follow up study, there are no arms Receives: Device: Renishaw Drug Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (AEs)[safety-tolerability]
Total number, causality and severity of adverse events at any time during the study period
Measured: Until study completion, up to month 58
Change in Electrocardiogram (ECG): Ventricular rate (bpm), [safety-tolerability]
Changes in electrical activity of heartbeat measured by electrocardiogram: Ventricular rate (bpm),
Measured: Week 71 and Month 25
Change in Electrocardiogram (ECG): PR (pulse rate) interval, qRS duration, QT, QTc (msec) [safety-tolerability]
Changes in electrical activity of heartbeat measured by electrocardiogram: PR interval (msec), QRS duration (msec), QT (msec), QTc (msec)
Measured: Week 71 and Month 25
Change in Beck Depression Inventory (BDI) score [safety-tolerability]
Assessment of change in depression using Beck Depression Inventory (BDI) score: Sadness: Pessimism; Past Failure; Loss of pleasure; Guilty feelings; Punishment Feelings; Self-dislike; Self-criticalness;Suicidal thoughts or wishes; Crying; Agitation; Loss of interest; Indecisiveness;Worthlessness; Loss of energy; Changes in sleeping pattern; Irritability; Changes in appetite; Concentration difficulty; Tiredness or fatique; Loss of interest in sex. Rated on a 4-point scale ranging from 0 to 3 based on severity of each item (0=low intensity; 3=highest intensity). The maximum total score is 63.
Measured: Week 71 and Month 25
Change in Questionnaire for impulsive-compulsive disorder in Parkinson's disease rating scale (QUIP_RS) [safety-tolerability]
Assessment of changes in impulsive-compulsive disorders using QUIP_RS. Questions scored 0-4 (0=never; 4=very often) on gambling, sex, buying, eating, performing tasks/hobbies, repeating simple activities, and taking Parkinson's disease medication. Total QUIP-RS Score 0-112
Assessment of changes in impulsive-compulsive disorders using QUIP_RS. Questions scored 0-4 (0=never; 4=very often) on gambling, sex, buying, eating, performing tasks/hobbies, repeating simple activities, and taking Parkinson's disease medication. Total QUIP-RS Score 0-112
Assessment of changes in impulsive-compulsive disorders using QUIP_RS. Questions scored 0-4 (0=never; 4=very often) on gambling, sex, buying, eating, performing tasks/hobbies, repeating simple activities, and taking Parkinson's disease medication. Total QUIP-RS Score 0-112
Measured: Week 71 and Month 25
Change in Montreal cognitive assessment (MoCA) [safety-tolerability]
Assessment of change in cognitive domains using MoCA test: attention and, concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: Week 71 and Month 25
Changes in physical examination: anatomic findings [safety-tolerability]
Changes in anatomic findings found in physical examination of the following body systems: general inspection/upper extremities; head, eyes, ears, nose, throat, and superficial cervial lymph notes; neck, shoulders, back; chest and lungs; cardiovascular; abdomen; lower extremities
Measured: Week 71, and Months 25, 34, 58
Changes in physical examination: clinical standard neurological examination
A clinical standard neurological examination by study investigator. Changes in motor function, sensory function, cranial nerve function (visual fields), cortical functions and reflexes are followed in the examination, scored as normal - abnormal without clinical relevance - abnormal with clinical relevance
Measured: Week 71, and Months 25, 34, 58
Changes in vital signs: blood pressure [safety-tolerability]
Changes in blood pressure during the study , measured as systolic and diastolic blood pressure (in mmHg)
Measured: Weeks 55, 57, 58, 75
Changes in vital signs: pulse rate [safety-tolerability]
Changes in pulse rate during the study (in beats per minute)
Measured: Weeks 55, 57, 58, 75
Changes in vital signs: body temperature [safety-tolerability]
Changes in body temperature during the study (in degrees celcius)
Measured: Weeks 55, 57, 58, 75
Changes in vital signs: body weight [safety-tolerability]
Changes in body weight during the study (in kilograms)
Measured: Weeks 55, 57, 58, 75
Changes in vital signs: body mass index (BMI) [safety-tolerability]
Changes in body mass index during the study (in kg/m^2)
Measured: Weeks 55, 57, 58, 75
Changes in clinical laboratory safety screen: clinical chemistry [safety-tolerability]
Changes in laboratory variables for clinical chemistry (Na, K, Urea, creatinine, creatine kinase, Ca, Bilirubin, IgG (Immunoglobulin G), Albumin, ALP(Alkaline phosphatase), ALT (Alanine transaminase), AST (Aspartate transaminase))
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: haematology - haemoglobin [safety-tolerability]
Changes in laboratory variables for haematology: hemoglobin (g/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: haematology - haematocrit [safety-tolerability]
Changes in laboratory variables for haematology: hematocrit (%, ratio of red blood cell volume to total blood volume). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: haematology - red blood cell (RBC) count [safety-tolerability]
Changes in laboratory variables for haematology: RBC count (10E12/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: mean cell volume (MCV) of red blood cells [safety-tolerability]
Changes in laboratory variables for haematology: MCV of red blood cells (fL). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: mean cell haemoglobin of RBC (MHC) [safety-tolerability]
Changes in laboratory variables for haematology: MCH (Mean cell hemoglobin) (pg). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: Platelet count [safety-tolerability]
Changes in laboratory variables for haematology: Platelet count (10E9/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: white blood call (WBC) count [safety-tolerability]
Changes in laboratory variables for haematology: Cell counts (10E9/L) for total WBC, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: activated partial thromboplastin time (aPTT) [safety-tolerability]
Changes in laboratory variables for haematology: aPTT (sec) . Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: International Normalised Ratio (INR) [safety-tolerability]
Changes in laboratory variables for haematology: INR (standardized prothrombin time) to determine the effects of oral anticoagulants on the clotting system. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in clinical laboratory safety screen: urinanalysis [safety-tolerability]
Changes in laboratory variables for urinanalysis (blood/erythrocytes, glucose, ketones, leukocytes, nitrites, pH, protein) studied by dipstick and scored 0-3. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Measured: Weeks 53, 55, 57, 58, 71 and Month 25
Formation of anti-CDNF antibodies [safety-tolerability]
Formation and change in anti-CDNF antibody concentration (in ng/ml).
Measured: Weeks 58, 78 and Month 25
Device related occurrence of adverse device effects [safety-tolerability]
Occurrence of adverse device effects (ADE) at any time of the study period, 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.
Measured: Week 49 and Month 58
Secondary outcomes (7)
Change in UPDRS (Unified Parkinson's Disease Rating Scale) Part III motor score [efficacy]
Changes in severity of PD (Parkinson's disease) motor symptoms assessed by UPDRS Part III motor scores (each scored 0-4; 0=none, 4=severe): Speech; facial expression; tremor a rest; Tremor of hands; rigidity; firger taps; hand movelents; alternating movement of hands; leg agility; rising from chair; posture; gait; postural stability; body bradykinesia and hypokinesia. The total score, the sum of scores received from 27 assessments, is 0 - 108
Measured: Week 71 and Month 25
Change in TUG (Timed Up and Go) test [efficacy]
Changes in mobility assessed by TUG test (in minutes and seconds).
Measured: Week 71 and Month 25
Change in UPDRS Total score (Part I-IV) [efficacy]
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): Part 1 (scored 0-16) Mentation, behaviour and mood. Part 2 (scored 0-52) Activities of daily living. Part 3 (scored 0-108) Motor examination. Part 4 (scored 0-23) Complications of therapy. The total score is 0-199 (0=totally healthy; 199=worst possible).
Measured: Week 71 and Month 25
Change in home diary score [efficacy]
Change in functional status of the patient's dyskinesias assessed by home diary score for three-day period. Each half hour is scored: sleep, OFF, ON without dyskinesias, ON with non-troublesome dyskinesias, ON with troublesome dyskinesias. The total time in each state over 3 days is recorded (in hours). The total "bad time" is defined as "OFF time" and "ON time with troublesome dyskinesia". The total "good time" is defined as "ON time without dyskinesia" or "ON time with non-troublesome dyskinesia".
Measured: Weeks 40, 45, 49, 53, 57, 58, 61, 65, 71, and Month 25
Change in PDQ-39 (Parkinson's Disease Questionnaire) score [efficacy]
Changes in health and daily activity assessed by a self-administered PDQ-39 questionnaire comprising of 39 questions related to eight key areas of health in Parkinson's patients: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Each question is evaluated on a scale of five terms "Never", "Occasionally", "Sometimes", "Often" or "Always or cannot do at all".
Measured: Week 71 and Month 25
Change in CGI-I (Clinical Global Impression - Improvement) scale [efficacy]
Change in mental status as measured by CGI-I scale rated by the clinical on a seven-point scale 1-7 (1=very much improved, 4=no change, 7=very much worse).
Measured: Weeks 40, 45, 49, 53, 57, 58, 61, 65, 71, and Month 25
Healing of patient skin after port removal
Any Adverse Events (AEs) or Serious Adverse Events (SAEs) related to the skin condition once the port has been removed
Measured: Month 25, 34 and 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start20 Mar 2019
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renishaw
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Herantis Pharma Plc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228653
- Sponsor's protocol ID
- HP-CD-CL-2004
- Status last verified
- Mar 2021
- First submitted
- 21 Aug 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-up Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Implanted With the DDS and/or Who Received Treatment in the Main Study and/or Extension Study
- ClinicalTrials.gov ID
- NCT04228653
- Acronym / sponsor ID
- HP-CD-CL-2004
- Conditions
- Parkinson Disease, Movement Disorders, Neuro-Degenerative Disease, Nervous System Diseases, Brain Diseases
- Keywords
- Parkinson, CDNF, Drug Delivery System, Intracerebral, Parkinson Disease, Nervous System Disease, Movement Disorders, Brain Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- RenishawIndustry (pharma, biotech, devices)
- Collaborators
- Herantis Pharma Plc.
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a follow up to the HP-CD-CL-2002 clinical study. It evaluates the long-term safety in patients with Parkinson's disease after implantation of an investigational drug delivery system (DDS) with or without infusions of CDNF. All patients will have at least the port explanted.
Detailed description
A patients participation in the study will last for up to 4 years and will include up to nine visits:
- Screening (1 visit, same as HP-CD-CL-2003 End-of-Study visit)
- Pre-surgery / explantation surgery / post-surgery (3 visits)
- Safety (4 visits)
- DAT-PET (Dopamine Transporter - Positron Emission Tomography) examination (1 visit)
- End-of-study visit (1 visit)
Study examinations and assessments:
- Physical examination: pulse rate, blood pressure, temperature, body weight and height, body mass index (BMI), neurological exam
- ECG (electrocardiography) and blood and urine tests
- Pregnancy tests for women of childbearing age
- Completion of a patient diary to record mobility and time asleep
- Parkinson's Kinetigraph (PKGTM) Data Logger: a watch-type movement recording device
- Questionnaires, rating scales and forms: quality of life, mood, memory, impulse control, mental health.
- Magnetic resonance imaging (MRI)
- Positron emission tomography scans (PET)
- Skin condition over any remaining implanted subcutaneous portion of the device.
- Skin healing after port / device removal.
For more information: https://treater.eu/clinical-study/
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| No Arm | Experimental | Device: Renishaw Drug Delivery SystemAs this is the follow up study, there are no arms |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Completion of visit 4 (implantation of DDS) within main study HP-CD-CL-2002.
- Patients who:
- Provision of informed consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renishaw Drug Delivery SystemDevice that allows pharmaceuticals to be delivered into the brain is to be assessed over a period of time to inform of the long term safety of the implanted device. | Device | No Arm |
Primary outcome
Incidence of treatment-emergent adverse events (AEs)[safety-tolerability]
Time frame: Until study completion, up to month 58
Total number, causality and severity of adverse events at any time during the study period
Change in Electrocardiogram (ECG): Ventricular rate (bpm), [safety-tolerability]
Time frame: Week 71 and Month 25
Changes in electrical activity of heartbeat measured by electrocardiogram: Ventricular rate (bpm),
Change in Electrocardiogram (ECG): PR (pulse rate) interval, qRS duration, QT, QTc (msec) [safety-tolerability]
Time frame: Week 71 and Month 25
Changes in electrical activity of heartbeat measured by electrocardiogram: PR interval (msec), QRS duration (msec), QT (msec), QTc (msec)
Change in Beck Depression Inventory (BDI) score [safety-tolerability]
Time frame: Week 71 and Month 25
Assessment of change in depression using Beck Depression Inventory (BDI) score: Sadness: Pessimism; Past Failure; Loss of pleasure; Guilty feelings; Punishment Feelings; Self-dislike; Self-criticalness;Suicidal thoughts or wishes; Crying; Agitation; Loss of interest; Indecisiveness;Worthlessness; Loss of energy; Changes in sleeping pattern; Irritability; Changes in appetite; Concentration difficulty; Tiredness or fatique; Loss of interest in sex. Rated on a 4-point scale ranging from 0 to 3 based on severity of each item (0=low intensity; 3=highest intensity). The maximum total score is 63.
Change in Questionnaire for impulsive-compulsive disorder in Parkinson's disease rating scale (QUIP_RS) [safety-tolerability]
Time frame: Week 71 and Month 25
Assessment of changes in impulsive-compulsive disorders using QUIP_RS. Questions scored 0-4 (0=never; 4=very often) on gambling, sex, buying, eating, performing tasks/hobbies, repeating simple activities, and taking Parkinson's disease medication. Total QUIP-RS Score 0-112 Assessment of changes in impulsive-compulsive disorders using QUIP_RS. Questions scored 0-4 (0=never; 4=very often) on gambling, sex, buying, eating, performing tasks/hobbies, repeating simple activities, and taking Parkinson's disease medication. Total QUIP-RS Score 0-112 Assessment of changes in impulsive-compulsive disorders using QUIP_RS. Questions scored 0-4 (0=never; 4=very often) on gambling, sex, buying, eating, performing tasks/hobbies, repeating simple activities, and taking Parkinson's disease medication. Total QUIP-RS Score 0-112
Change in Montreal cognitive assessment (MoCA) [safety-tolerability]
Time frame: Week 71 and Month 25
Assessment of change in cognitive domains using MoCA test: attention and, concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
Changes in physical examination: anatomic findings [safety-tolerability]
Time frame: Week 71, and Months 25, 34, 58
Changes in anatomic findings found in physical examination of the following body systems: general inspection/upper extremities; head, eyes, ears, nose, throat, and superficial cervial lymph notes; neck, shoulders, back; chest and lungs; cardiovascular; abdomen; lower extremities
Changes in physical examination: clinical standard neurological examination
Time frame: Week 71, and Months 25, 34, 58
A clinical standard neurological examination by study investigator. Changes in motor function, sensory function, cranial nerve function (visual fields), cortical functions and reflexes are followed in the examination, scored as normal - abnormal without clinical relevance - abnormal with clinical relevance
Changes in vital signs: blood pressure [safety-tolerability]
Time frame: Weeks 55, 57, 58, 75
Changes in blood pressure during the study , measured as systolic and diastolic blood pressure (in mmHg)
Changes in vital signs: pulse rate [safety-tolerability]
Time frame: Weeks 55, 57, 58, 75
Changes in pulse rate during the study (in beats per minute)
Changes in vital signs: body temperature [safety-tolerability]
Time frame: Weeks 55, 57, 58, 75
Changes in body temperature during the study (in degrees celcius)
Changes in vital signs: body weight [safety-tolerability]
Time frame: Weeks 55, 57, 58, 75
Changes in body weight during the study (in kilograms)
Changes in vital signs: body mass index (BMI) [safety-tolerability]
Time frame: Weeks 55, 57, 58, 75
Changes in body mass index during the study (in kg/m^2)
Changes in clinical laboratory safety screen: clinical chemistry [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for clinical chemistry (Na, K, Urea, creatinine, creatine kinase, Ca, Bilirubin, IgG (Immunoglobulin G), Albumin, ALP(Alkaline phosphatase), ALT (Alanine transaminase), AST (Aspartate transaminase))
Changes in clinical laboratory safety screen: haematology - haemoglobin [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for haematology: hemoglobin (g/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Changes in clinical laboratory safety screen: haematology - haematocrit [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for haematology: hematocrit (%, ratio of red blood cell volume to total blood volume). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Changes in clinical laboratory safety screen: haematology - red blood cell (RBC) count [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for haematology: RBC count (10E12/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Changes in clinical laboratory safety screen: mean cell volume (MCV) of red blood cells [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for haematology: MCV of red blood cells (fL). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Changes in clinical laboratory safety screen: mean cell haemoglobin of RBC (MHC) [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for haematology: MCH (Mean cell hemoglobin) (pg). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Changes in clinical laboratory safety screen: Platelet count [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for haematology: Platelet count (10E9/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Changes in clinical laboratory safety screen: white blood call (WBC) count [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for haematology: Cell counts (10E9/L) for total WBC, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Changes in clinical laboratory safety screen: activated partial thromboplastin time (aPTT) [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for haematology: aPTT (sec) . Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Changes in clinical laboratory safety screen: International Normalised Ratio (INR) [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Months 25, 34, 58
Changes in laboratory variables for haematology: INR (standardized prothrombin time) to determine the effects of oral anticoagulants on the clotting system. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Changes in clinical laboratory safety screen: urinanalysis [safety-tolerability]
Time frame: Weeks 53, 55, 57, 58, 71 and Month 25
Changes in laboratory variables for urinanalysis (blood/erythrocytes, glucose, ketones, leukocytes, nitrites, pH, protein) studied by dipstick and scored 0-3. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance".
Formation of anti-CDNF antibodies [safety-tolerability]
Time frame: Weeks 58, 78 and Month 25
Formation and change in anti-CDNF antibody concentration (in ng/ml).
Device related occurrence of adverse device effects [safety-tolerability]
Time frame: Week 49 and Month 58
Occurrence of adverse device effects (ADE) at any time of the study period, 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.
7 secondary outcomes
Change in UPDRS (Unified Parkinson's Disease Rating Scale) Part III motor score [efficacy]
Time frame: Week 71 and Month 25
Change in TUG (Timed Up and Go) test [efficacy]
Time frame: Week 71 and Month 25
Change in UPDRS Total score (Part I-IV) [efficacy]
Time frame: Week 71 and Month 25
Change in home diary score [efficacy]
Time frame: Weeks 40, 45, 49, 53, 57, 58, 61, 65, 71, and Month 25
Change in PDQ-39 (Parkinson's Disease Questionnaire) score [efficacy]
Time frame: Week 71 and Month 25
Change in CGI-I (Clinical Global Impression - Improvement) scale [efficacy]
Time frame: Weeks 40, 45, 49, 53, 57, 58, 61, 65, 71, and Month 25
Healing of patient skin after port removal
Time frame: Month 25, 34 and 58
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Renishaw Drug Delivery System in people with Parkinson Disease and Movement Disorders, run by Renishaw at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (AEs)[safety-tolerability] (time frame: Until study completion, up to month 58). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.