Idiopathic Parkinson's Disease MedDRA version: 21.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852
Conditions
Sponsors
Renishaw Neuro Solutions Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who completed Visit 4, implantation of the DDS, in the main study (HP-CD-CL-2002). 2. Patients that fulfil any of the following criteria: a. Discontinued the main study (HP-CD-CL-2002) after Visit 4, or, the extension study (HP-CD-CL-2003), or, b. Completed the main study (HP-CD-CL-2002) having received 6 doses of treatment, but did not continue in the extension study (HP-CD-CL-2003), or, c. Patients that completed also the extension study, receiving a total of 12 doses of treatment (HP-CD-CL-2003). 3. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: None.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the long-term safety and tolerability of – The implanted IMD, and, – The previous administered bilateral intraputamenal IMP infusions;Secondary Objective: Evaluate the device: • The patient’s skin healing after port removal • The safety of the explantation procedures, when also subcutaneous and brainimplanted parts of the DDS are removed Evaluate the long-term drug related effects: • the severity of PD motor symptoms as measured by OFF-state UPDRS motor scores (part III) • mobility as measured by OFF-state TUG test • ON-state non-motor and motor function, motor complications, and ON- and OFF-state activities of daily living • functional status by PD home diary • health and daily activities as measured by PDQ-39 questionnaire • treatment response on mental status as measured by CGI scale Exploratory objectives: To evaluate the drug related effects on • the change in caudate and putamen dopamine transporter (DAT) availability after 7 months since last treatment infusion, using PET imaging • the daily activity measurement by Parkinson’s KinetiGraph;Primary end point(s): Device related • Occurrence of adverse device effects (ADE), for either the whole system or the individual sub systems (guide tubes/catheters, subcutaneous components, port), evaluated separately for o the explantation procedure (Week 55), o the healing period (Weeks 55 to 57), o the subsequent safety visits during the entire study period outside of the explantation and healing period (Week 55 to Week 57), with serious adverse device effect (SADE), including long term pathological changes seen by MRI , neurological deficit (seizures), infection (local to components, in CNS), severe skin breakdown or necrosis requiring component removal and life threatening or major (requiring intervention) intracerebral haemorrhage up to 5 y | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Drug related 1. Change from baseline (Week -1), study start (Week 49) and after thirteen months of follow-up (Month 25) in severity of PD motor symptoms by UPDRS Part III motor scores. 2. Change from baseline (Week -1), study start (Week 49) and after thirteen months of follow-up (Month 25) in mobility by TUG test. 3. Change from baseline (Week -1), study start (Week 49) and after thirteen months of follow-up (Month 25) in severity of PD non-motor and motor symptoms by UPDRS Part I-IV total scores (Parts I, II and IV in ON-state; Part III in OFF-state). 4. Change from baseline (Week -1), study start (Week 49) and after thirteen months of follow-up (Month 25) in functional status by home diary score. 5. Change from baseline (Week -1), study start (Week 49) and after thirteen months of follow-up (Month 25) in health and daily activity by PDQ-39 questionnaire score. 6. Change from baseline (Week -1), study start (Week 49) and after thirteen months of follow-up (Month 25) in mental status as measured by CGI-I scale. Exploratory Endpoints Drug related (only for patients that have baseline DAT-PET and PKG TM data from HP-CD-CL-2002) 1. Change in caudate and putamen DAT availability from the previous DAT-PET image(s) in study HP-CD-CL-2002 (Week -2 and 22) or Study HP-CD-CL-2003 (Week47) and until seven months since the last treatment visit (Visit 33, Week 75) using PET imaging with [ 18 F]FE-PE2I to assess the integrity of the nigrostriatal system. 2. Change from inclusion (Week 49), after three months (Week 58) and until seven months since the last treatment visit (Week 71) in daily activity measurement by Parkinson’s KinetiGraph™ (PKG™) Data Logger. ;Timepoint(s) of evaluation of this end point: Drug related 1. - 3. baseline (Week -1), study start (Week 49) and after thirteen months of follow-up (Month 25) 4. - 6. baseline (Week -1), study start (Week | — |
Countries
Finland, Sweden
Contacts
Public ContactProject Manager
Renishaw Neuro Solutions Ltd.
Outcome results
None listed