| First Published on Clinicaltrials.gov: |
11/29/2008 |
| Status: |
This study has been completed |
| ClinicalTrials.gov ID: |
NCT00800501 |
| Sponsor: |
NeuroNova AB |
| Purpose: |
This study is conducted to evaluate the safety and tolerability of the drug product sNN0029, containing the growth factor VEGF165, when administered directly into one of the fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed II pump. Patients with Amyotrophic Lateral Sclerosis will be enrolled. |
| Phase: |
I/II |
| Treatment Type: |
Surgical Administration with Catheter |
| Trial Type: |
Double Blind, Placebo Control |
| Estimated Enrollment: |
18 |
| Eligibility: |
18 years to 75 years. Both Genders. No healthy volunteers. |
| Details: |
Two arm study: experimental continuous ICV infusion at one of three dose levels of sNN0029, placebo continuous ICV infusion of placebo.NeuroNova intends to investigate whether intracerebroventricular administration of VEGF165 in the form of the drug product sNN029 can improve motor function and prolong survival in patients with ALS, and in this first study the safety and tolerability of treatment for 3 months will be evaluated. |
| Collaborator(s): |
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| Location(s): |
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| Primary Investigator: |
Wim Robberecht, MD PhD University Hospital Leuven, Department of Neurology |
| Contact: |
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| Trial Protocol as Published on Clinicaltrials.gov: |
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| ALS Forum: |
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