Trial Search Results

Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease

The purpose of this study is to evaluate the safety and potential benefits of CERE-120 in the treatment of Parkinson's disease. CERE-120 is an experimental drug that consists of an adeno-associated virus (AAV) that was engineered to carry the human gene for neurturin, a neurotrophic (growth) factor. Similar to other growth factors (such as GDNF), neurturin is capable of restoring function and protecting brain cells from further damage. The virus used in CERE-120 is not known to cause disease in people.

CERE-120 is delivered directly to the brain cells most affected in Parkinson's disease - the dopamine producing neurons. CERE-120 is injected during brain surgery. Once in place, CERE-120 continuously produces neurturin.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Sangamo Therapeutics

Stanford Investigator(s):

Intervention(s):

  • Biological: CERE-120: Adeno-Associated Virus Delivery of Neurturin
  • Procedure: Sham Surgery

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Males and females, ages 35 to 70 years old (inclusive)

   - A diagnosis of idiopathic Parkinson's disease based on UK Brain Bank criteria,
   including bradykinesia and at least 1 of the following PD features: resting tremor or
   rigidity

   - A Hoehn and Yahr score of no greater than 3 in the "off" condition at Screening

   - A robust response to dopaminergic therapy as judged by the investigator based on the
   UPDRS Part III: Motor Examination

   - Experiencing motor complications despite adequate antiparkinsonian therapy

   - A stable, optimized regimen of antiparkinsonian medications and stable parkinsonian
   features for at least 6 weeks prior to Screening

   - Subject is willing not to undergo DBS for at least 12 months after the study surgical
   procedure (Phase 1 subjects) or while the study is blinded (Phase 2 subjects) and the
   investigator believes that this is medically acceptable

   - Medically fit to undergo the study surgical procedure as determined by medical
   history, clinical and laboratory evaluations, and any other pre-surgical evaluations
   that are standard at the institution where the subject will undergo surgery

   - Physically and mentally capable of performing all protocol-specified assessments and
   complying with the study visit schedule

   - Subjects must be able to travel to study visits alone or able to identify a partner or
   caregiver who agrees to accompany the subject to the study visits

   - Females of childbearing potential must have a negative β-HCG pregnancy test at
   Screening and again before surgery on Day 0

   - All subjects, both male and female, must agree to practice adequate barrier method
   contraception for at least 6 months after the surgical procedure

   - Provides written informed consent to participate before any study-specific procedures
   are conducted

Exclusion Criteria:

   - Atypical or secondary parkinsonism, including, but not limited to, multiple system
   atrophy (MSA) or progressive supranuclear palsy

   - Any subject for whom participation in the study would pose a substantial safety risk

   - Any condition that would compromise the ability of the subject to undergo study
   procedures, including allergy to gadolinium

   - Presence of any known brain abnormality that could interfere with the assessment of
   safety or efficacy or represents a surgical risk to the subject

   - Evidence of significant brain atrophy on the Baseline MRI

   - History of any cancer other than basal or squamous cell skin cancer within the 3 years
   prior to Screening

   - Any chemotherapy, cytotoxic therapy, or immunotherapy (e.g., IL-2, IL-12, interferon)
   within the 3 months prior to Screening

   - Any prior treatment for PD with a procedure involving intracranial surgery or
   implantation of a device (e.g. DBS, pallidotomy)

   - Any prior treatment for a neurological or psychiatric disorders with a procedure
   involving the implantation of a device (e.g. spinal cord stimulator, vagus nerve
   stimulator)

   - History of any prior gene transfer therapy

   - Treatment with any investigational agent within the 3 months prior to Screening

   - Anticipated need for antiplatelet agents or anticoagulation therapy, including gingko
   biloba, during the 10 days prior to the projected surgery date

   - Any vaccinations within the 30 days prior to the projected surgery date Note:
   Vaccinations are not allowed for 30 days after the surgical procedure, unless deemed
   necessary by the investigator for the subject's well-being

   - Not likely to be available for the duration of the trial, likely to be noncompliant
   with the protocol, or who are deemed unsuitable by the investigator for any other
   reason

   - Participation in a previous surgical treatment study for Parkinson's disease

Ages Eligible for Study

35 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sandra Dunn
6507248278
Not Recruiting