Transl Clin Pharmacol.  2017 Dec;25(4):162-165. 10.12793/tcp.2017.25.4.162.

Post lumbar puncture headache: Case report of a serious adverse event in first-in-human study

• Shin W
• Kim MK
• Kim J
• Woo MH
• Cho DY
• Lim KS

• KMID: 2406996
• DOI: http://doi.org/10.12793/tcp.2017.25.4.162

Abstract

A lumbar puncture can be used to measure the concentrations of drugs and/or pharmacodynamic biomarkers during clinical trials of central nervous system drugs. We report a case of a post lumbar puncture headache (PLPH) in a first-in-human study, which was reported as a serious adverse event. A 20-year-old man received 200 mg of the investigational product (IP) for 7 days and underwent a lumbar puncture for cerebrospinal fluid sampling before IP administration (Day 1, pre-dose) and after 7 days and multiple IP administrations (Day 7, 1 hour post-dose). After discharge on Day 8, the subject complained of headache, nausea, vomiting, neck stiffness, and numbness of the extremities. The symptoms occurred when he got up and disappeared after he remained in the supine position for several minutes. Five days later, he visited the neurology clinic of the main hospital. The neurologist recommended hospitalization for further evaluation and symptom management, and the subject was then admitted to the hospital. There were no abnormal findings in vital signs, laboratory results, or brain-computed tomography. His symptoms disappeared during the hospitalization period. It was important to distinguish whether the headache was IP-related or lumbar puncture-related. Therefore, knowledge of clinical characteristics and differential diagnosis of PLPH is paramount. Furthermore, if severe PLPH occurs, a consultation with a neurologist and imaging studies should be considered for a differential diagnosis of PLPH.

Keyword

Post lumbar puncture headache; Serious adverse event; Lumbar puncture; First-in-human

MeSH Terms

Biomarkers
Central Nervous System Agents
Cerebrospinal Fluid
Diagnosis, Differential
Extremities
Headache*
Hospitalization
Humans
Hypesthesia
Nausea
Neck
Neurology
Spinal Puncture*
Supine Position
Vital Signs
Vomiting
Young Adult
Biomarkers
Central Nervous System Agents

Figure

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  Figure 1 Brain CT of the subject showing no abnormal finding.

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