Parkinson's disease MedDRA version: 18.1 Level: LLT Classification code 10034008 Term: Parkinson's syndrome System Organ Class: 100000004852
Conditions
Sponsors
North Bristol NHS Trust (NBT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to qualify for entry into the study, subjects MUST meet all of the following criteria: 1. Enrolled and completed treatment in the Pilot or Primary Study Stages of Study 2553. 2. Females of childbearing potential must have a negative pregnancy test at study entry and be willing to use an approved (by the PI or designee) form of contraception until the end of the study. 3. Males with female partners of childbearing potential must be willing to use condoms for contraception until the end of the study. 4. Provision of 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will NOT be eligible for inclusion in the study: 1. Discontinued treatment early in Study 2553. 2. Had any significant (in the opinion of the PI or designee) protocol deviation in Study 2553; this includes receipt of any disallowed anti-parkinsonian treatment or any investigational treatment. 3. Presence of clinically significant (in the opinion of the PI) depression. 4. MoCA score < 24 at the final assessment in Study 2553. 5. Any new medical condition which might impair outcome measure assessments or safety measures including ability to undergo MRI scanning.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of intermittent bilateral intraputamenal GDNF infusions on OFF-state motor function after 18 months of treatment with the effects after 9 months of treatment in subjects who completed in Study 2553.; Secondary Objective: To compare the effects of intermittent bilateral intraputamenal GDNF infusions on ON-state motor function, motor complications, & ON- & OFF-state activities of daily living after 18m treatment with the effects after 9m treatment in subjects who completed Study 2553. • To assess the safety of intermittent bilateral intraputamenal GDNF infusions at 18m in subjects who received GDNF or placebo for 9m in Study 2553. • To explore the effects of intermittent bilateral intraputamenal GDNF infusions on other motor & non-motor functions, quality of life assessments, & imaging endpoints at 18 months in subjects who completed Study 2553. • To compare the results for various motor outcomes between the subjects who started GDNF early (i.e. were randomized to GDNF in Study 2553) & those who started GDNF late (i.e. were randomized to placebo in Study 2553). • Pilot Extension: To generate long-term safety data & provide continued access to GDNF until results of Study 2553 are available ;Primary end point(s): The primary endpoint of the study is the percentage change from baseline to the end of treatment in the practically defined OFF-state UPDRS motor score (part III).; Timepoint(s) of evaluation of this end point: 9 months of treatment in extension study (18 months treatment overall including treatment in study 2553) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage change from baseline to the end of treatment in UPDRS motor score (part III) in the ON-state (following a levodopa challenge) • Percentage change from baseline to the end of treatment in UPDRS ADL (part II) . • Change from baseline to the end of treatment in PD diary ratings; i.e., total OFFtime per day, total good quality ON-time (ON without dyskinesias or ON with non-troublesome dyskinesias) and ON-time with troublesome dyskinesias ; Timepoint(s) of evaluation of this end point: 9 months of treatment in extension study (18 months treatment overall including treatment in study 2553) Pilot subjects only will be eligible for up to an additional 80 weeks of Treatment (Pilot Extension). | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Manager Helen Lewis
North Bristol NHS Trust (NBT)
Outcome results
None listed