NCT01117090 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Coffey RJ, Miesel K, Billstrom T
Cerebrospinal fluid pressure measurement in the ovine intrathecal space: a preliminary study towards the diagnosis of intrathecal drug administration catheter dislodgement or occlusion. Stereotact Funct Neurosurg. 2010;88(6):337-44. doi: 10.1159/000319034. Epub 2010 Aug 21.
Saulino M, Miesel K, Turner M, Cochran F, Stromberg K, Fehrmann E, Markert M
Can CSF pressure signals distinguish catheter complications from normal catheter function in subjects who experience loss of intrathecal baclofen therapy? Abstract submitted to

Feasibility of Measuring Cerebrospinal Fluid (CSF) Signatures in Subjects With Intrathecal Catheter-Related Problems

Clinical trial NCT01117090 - References