PMID- 32095469
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2289-0882 (Print)
IS  - 2383-5427 (Electronic)
IS  - 2289-0882 (Linking)
VI  - 25
IP  - 4
DP  - 2017 Dec
TI  - Post lumbar puncture headache: Case report of a serious adverse event in 
      first-in-human study.
PG  - 162-165
LID - 10.12793/tcp.2017.25.4.162 [doi]
AB  - 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.
CI  - Copyright (c) 2017 Translational and Clinical Pharmacology.
FAU - Shin, Wonsuk
AU  - Shin W
AD  - Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, 
      CHA University, Seongnam 13496, Republic of Korea.
FAU - Kim, Min-Kyoung
AU  - Kim MK
AD  - Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, 
      CHA University, Seongnam 13496, Republic of Korea.
AD  - Department of Psychiatry, CHA Bundang Medical Center, CHA University, Seongnam 
      13496, Republic of Korea.
FAU - Kim, Jinkwon
AU  - Kim J
AD  - Department of Neurology, CHA Bundang Medical Center, CHA University, Seongnam 
      13496, Republic of Korea.
FAU - Woo, Min-Hee
AU  - Woo MH
AD  - Department of Neurology, CHA Bundang Medical Center, CHA University, Seongnam 
      13496, Republic of Korea.
FAU - Cho, Doo-Yeon
AU  - Cho DY
AD  - Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, 
      CHA University, Seongnam 13496, Republic of Korea.
FAU - Lim, Kyoung Soo
AU  - Lim KS
AD  - Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, 
      CHA University, Seongnam 13496, Republic of Korea.
LA  - eng
PT  - Case Reports
DEP - 20171220
PL  - Korea (South)
TA  - Transl Clin Pharmacol
JT  - Translational and clinical pharmacology
JID - 101639331
PMC - PMC7033405
OTO - NOTNLM
OT  - First-in-human
OT  - Lumbar puncture
OT  - Post lumbar puncture headache
OT  - Serious adverse event
COIS- Conflict of Interest: -Authors: The author has no conflict of interest. 
      -Reviewers: Nothing to declare -Editors: Nothing to declare
EDAT- 2017/12/01 00:00
MHDA- 2017/12/01 00:01
PMCR- 2017/12/20
CRDT- 2020/02/26 06:00
PHST- 2017/08/22 00:00 [received]
PHST- 2017/11/09 00:00 [revised]
PHST- 2017/11/11 00:00 [accepted]
PHST- 2020/02/26 06:00 [entrez]
PHST- 2017/12/01 00:00 [pubmed]
PHST- 2017/12/01 00:01 [medline]
PHST- 2017/12/20 00:00 [pmc-release]
AID - 10.12793/tcp.2017.25.4.162 [doi]
PST - ppublish
SO  - Transl Clin Pharmacol. 2017 Dec;25(4):162-165. doi: 10.12793/tcp.2017.25.4.162. 
      Epub 2017 Dec 20.