- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02347878
Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)
January 26, 2015 updated by: Liang Wang, Sun Yat-sen University
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
85
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment arm
this treatment arm will received aprepitant 1 hour before lumbar puncture and intrathecal treatment.
|
use aprepitant 1 hour before lumbar puncture and intrathecal treatment
Other Names:
|
No Intervention: control arm
this arm will received nothing 1 hour before lumbar puncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of any grade post-lumbar-puncture headache
Time Frame: date from the day of lumbar puncture to 2 weeks after lumbar puncture
|
date from the day of lumbar puncture to 2 weeks after lumbar puncture
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of grade 3/4 post-lumbar-puncture headache
Time Frame: date from the day of lumbar puncture to 2 weeks after lumbar puncture
|
date from the day of lumbar puncture to 2 weeks after lumbar puncture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
January 21, 2015
First Submitted That Met QC Criteria
January 26, 2015
First Posted (Estimate)
January 27, 2015
Study Record Updates
Last Update Posted (Estimate)
January 27, 2015
Last Update Submitted That Met QC Criteria
January 26, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLPH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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