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Clinical Trials/EUCTR2011-003866-34-GB
EUCTR2011-003866-34-GBActive, not recruitingPhase 1

A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease

orth Bristol NHS Trust (NBT)0 sites42 target enrollmentStarted: May 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
42
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •Inclusion Criteria
  • •1. Subjects diagnosed with idopathic PD according to the UK Brain Bank Criteria. Bilateral findings must be present at study entry.
  • •2. Duration of PD symptoms 5 years, verified by subject’s medical records.
  • •3. Age 35-75 years.
  • •4. Presence of motor fluctuations. Subjects must have an average of at least 2.5 hours of Off-time per day on 3-day
  • •fluctuation diaries completed during screening.
  • •5. Ability to reliably distinguish motor states (ON without dyskinesias, ON with non-troublesome dyskinesias, ON with
  • •troublesome dyskinesias and OFF) and accurately complete fluctuation diaries.
  • •6. UPDRS motor score (part III) in a practically defined OFF-state between 25-45.
  • •7. Hoehn and Yahr = stage III in the OFF-state.
  • •8. Responsiveness to levodopa (=40% improvement in motor UPDRS [part III] following a levodopa challenge)
  • •9. No change in anti-parkinsonian medication for 6 weeks before screening.
  • •10. 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.
  • •11. Provision of informed consent.
  • •Post-surgery Randomization Criteria
  • •1. No relevant sequelae from catheter implantation such as clinically significant intracerebral trauma, haemorrhage, or infection.
  • •2. Total distribution volume providing at least 50% volume coverage of a predefined volume of interest in each putamen (approximately 25% volume coverage of total putamen), as assessed by an independent review of an MRI scan taken within 2 hours post-infusion of diluent at the end of the healing period.
  • •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

  • •1. Diagnosed with atypical parkinsonism or any known secondary parkinsonian syndrome including but not limited to
  • •medication induced, toxic, vascular, post-traumatic or post-infectious parkinsonism, progressive supranuclear palsy,
  • •multiple systems atrophy, or other neurodegenerative disorder associated with parkinsonism.
  • •2. Signs or symptoms suggestive of atypical parkinsonian syndrome including supranuclear gaze palsy, early postural
  • •instability and falls (within 3 years of disease onset), cerebellar signs, myoclonus, disproportionate antecollis,
  • •extensor plantar responses, cortical sensory loss, emotional incontinence (pseudobulbar affect), severe bulbar
  • •dysfunction (dysarthria, dysphonia or dysphagia) or respiratory symptoms such as stridor or inspiratory sighs.
  • •3. Family history of more than 1 first-degree relative with PD.
  • •4. Severe dyskinesias or severe tremor which could interfere with GDNF infusion.
  • •5. Prior neurosurgical treatment for PD, including previous treatment with GDNF or deep brain stimulation.
  • •6. Significant neurological disorder other than PD including clinically significant head trauma, cerebrovascular disease,
  • •CSF shunt or other implanted CNS device.
  • •7. Presence of significant depression as defined as a Beck Depression Inventory (BDI) score = 20.
  • •8. Current or past history of psychosis requiring therapy. The presence of benign hallucinosis is not exclusionary.
  • •9. Presence or history of clinically significant impulse control disorder or presence or history of dopamine dysregulation syndrome.
  • •10. MoCA score < 24.
  • •11. Use within 3 months of planned catheter insertion of concomitant medications known to affect PD symptoms other
  • •than prescribed PD therapy including but not limited to neuroleptics or other central dopamine receptor blockers.
  • •12. Any medical condition which might impair outcome measure assessments or safety measures including ability to
  • •undergo MRI scanning.
  • •13. Screening MRI demonstrating any abnormality which would suggest an alternative cause for subject’s parkinsonism.
  • •14. Any medical condition that would put the subject at undue risk from surgical treatment or chronic implants including
  • •but not limited to bleeding disorders, chronic infections, or immunosuppressive illness.
  • •15. History within the last 5 years of cancer with the exception of basal cell carcinoma of the skin.
  • •16. History of drug or alcohol abuse within 2 years of planned catheter insertion.
  • •17. Use of any investigational drug or device within 90 days of planned catheter insertion.
  • •18. Active breastfeeding.

Investigators

Sponsor
orth Bristol NHS Trust (NBT)

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