Continuously Infused Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (GDNF) to Treat Progressive Supranuclear Palsy

Exclusion Criteria

• •1. Treatment with levodopa, dopamine agonists or any other antiparkinsonian medications.
• •2. Presence of clinically significant psychosis or hallucinations.
• •3. Any disorder that precludes a surgical procedure (e.g., bleeding diathesis, signs of sepsis or inadequately treated infection) alters wound healing or renders bilateral catheter and infusion pump implants unsuitable.
• •4. Any history of clinically significant head trauma or cerebrovascular disease or recent history (within previous 2 years) of drug or alcohol abuse.
• •5. A computed tomography (CT) scan or magnetic resonance image (MRI) of the brain within 3 months before the implantation procedure that indicates the presence of a central nervous system abnormality that may interfere with the assessments of safety or biologic effect in this protocol, or represent a surgical risk to the subject.
• •6. The presence of an intracranial shunt or catheter system other than the one used in this protocol.
• •7. Any medical disability, condition or laboratory abnormality (e.g., severe degenerative arthritis, compromised nutritional state, body weight less than 15% of ideal, Na less than 130 (grade 3 or above), cardiovascular disease) that would be deemed likely to increase risk of participation in the protocol or interfere with assessment of the safety and biologic effect of study materials, the chronic implantation of catheters and infusion pumps, or would compromise the ability of the subject to give informed consent.
• •8. Known allergy to E coli-derived products or history of anaphylaxis.
• •9. Treatment with an investigational agent or used an investigational device within 60 days before the first dose of study material, other than those described in this protocol.