Safety, Tolerability, and Activity Study of ISIS SOD1Rx to Treat Familial Amyotrophic Lateral Sclerosis (ALS) Caused by SOD1 Gene Mutations
| Status: | Archived |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2010 |
| End Date: | December 2011 |
A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of ISIS 333611 Administered Intrathecally to Patients With Familial Amyotrophic Lateral Sclerosis Due to Superoxide Dismutase 1 Gene Mutations
This study will test the safety, tolerability and pharmacokinetics of single doses of ISIS
333611 administered into the spinal canal as 12 hour infusions.
This study will test the safety, tolerability, and pharmacokinetics of single doses of ISIS
333611 administered as 12-hour intrathecal infusions. Four dose levels (0.15, 0.5, 1.5 and
3 mg) will be evaluated sequentially. The volume of the infusion is 0.25 mL/12 hours. Each
dose level will be studied in a cohort of 8 patients where 6 are randomized to active
treatment with ISIS 333611 and 2 are randomized to placebo.
We found this trial at
6
sites
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Charlestown, Massachusetts 02129
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