Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02347878
Recruitment Status : Unknown
Verified January 2015 by Liang Wang, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : January 27, 2015
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Liang Wang, Sun Yat-sen University

Brief Summary:
Headache following a lumbar puncture (post-lumbar-puncture headache,PLPH)is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Drug: Aprepitant Phase 4

Detailed Description:
Headache following a lumbar puncture (post-lumbar-puncture headache,PLPH)is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)
Study Start Date : April 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Aprepitant

Arm Intervention/treatment
Experimental: treatment arm
this treatment arm will received aprepitant 1 hour before lumbar puncture and intrathecal treatment.
Drug: Aprepitant
use aprepitant 1 hour before lumbar puncture and intrathecal treatment
Other Name: Emend

No Intervention: control arm
this arm will received nothing 1 hour before lumbar puncture



Primary Outcome Measures :
  1. incidence of any grade post-lumbar-puncture headache [ Time Frame: date from the day of lumbar puncture to 2 weeks after lumbar puncture ]

Secondary Outcome Measures :
  1. incidence of grade 3/4 post-lumbar-puncture headache [ Time Frame: date from the day of lumbar puncture to 2 weeks after lumbar puncture ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed as acute leukemia, or lymphoma
  • Patients will received repeated lumbar puncture (at least 2 times, and at least 2 weeks apart) and intrathecal treatment
  • Without CNS involvement
  • Without headache for at least 1 week before the day of lumbar puncture
  • The platelet count was at least 30×10e9/L

Exclusion Criteria:

  • With CNS involvement of disease
  • With headache before lumbar puncture
  • Needs lumbar puncture more than once a week

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347878


Contacts
Layout table for location contacts
Contact: Liang Wang, doctor +86-20-87342462 wangliang@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Liang Wang, Doctor    +86-20-87342462    wangliang@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Liang Wang, DOCTOR Sun Yat-sen University

Layout table for additonal information
Responsible Party: Liang Wang, Doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02347878     History of Changes
Other Study ID Numbers: PLPH
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Liang Wang, Sun Yat-sen University:
leukemia
lymphoma
lumbar puncture
intrathecal treatment
post-lumbar puncture headache

Additional relevant MeSH terms:
Layout table for MeSH terms
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action