Cerebrospinal fluid (CSF) sampling
Sampling of cerebrospinal fluid (CSF) is an essential step for early-phase drug development studies, and particularly for studies in neurology. As CSF drug concentrations reflect unbound drug concentrations in the brain, this procedure is of critical importance for gaining insight into the delivery of drugs that act on targets in the central nervous system (CNS). In addition, CSF biomarkers are vital for indicating pharmacodynamic action of CNS drugs in clinical trials, as well as providing an excellent basis for go/no go decisions in the drug development process.
What CHDR offers
- Extensive experience in early-phase clinical trials involving healthy volunteers and patients with a variety of conditions, especially neurodegenerative diseases
- Capacity to conduct numerous lumbar punctures (~300 single punctures per year) in our Clinical Research Unit
- Excellent quality of CSF collection with high success rate and less than 2% post-puncture headache
- An experienced and highly-trained team of physicians and two in-house neurologists assisted by dedicated nursing staff
- Expertise and support from the department of anaesthesiology of our partner hospital, the Leiden University Medical Center
- 24/7 pharmacy and bioanalytical laboratory facilities
CSF sampling techniques applied at CHDR
Single lumbar puncture:
- Performed under local anaesthesia
- Used for direct PK and/or PD assessments in the CNS compartment, as well as for intrathecal drug administration
- Performed under local anaesthesia
- Used for direct PK and/or PD assessments in the CNS compartment, as well as for intrathecal drug administration
Continuous sampling with spinal catheter:
- Performed under local anaesthesia
- Used when serial CSF sampling is needed for
pharmacokinetic and/or pharmacodynamic profiling
