The primary objective of this study is to investigate whether differences in patient specific pharmacokinetic properties, both dynamic and absolute, reveal the difference in response to lithium treatment. The pharmacokinetic properties which will be…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine whether there is a correlation between the frequency of cluster
headache attacks and the absminLi.
Secondary outcome
We will describe the relation between the t1/2 and 12h-Li and the frequency of
attacks. Furthermore, we will compare the results of the Liattack with the
Licontrol measurements. Finally, we will evaluate the use of additional
medication and the kidney function.
Background summary
Patients who have unsuccesfully been treated with verapamil as prophylactic
medication for their CH might benefit from lithium as maintenance prophylaxis.
The clinical outcome under lithium treatment differs between patients. Some
patients are free from clusterheadache attacks, whereas others still experience
attacks. Nevertheless, these attacks are less frequent, shorter in duration and
/ or less severe. Specific pharmacokinetic properties have not been studies as
potential cause of the difference in clinical outcome. In this study we would
like to assess both dynamic, the elimination half life (t1/2), and absolute
properties, concentrations, of lithium in CH patients. It is hypothesized that
a correlation between the absminLi, the minimal concentration of lithium prior
to the intake of lithium, and the amount of clusterheadache attacks can be
found. Furthermore, the relation between t1/2 and the concentration 12 hours
post intake (12h-Li) on one hand and the frequency of attacks on the other
hand, might reveal the response of a patient to lithium medication.
Additionally, the lithium concentration during an attack (Liattack) is compared
with a matched-control measurement (Licontrol).
Study objective
The primary objective of this study is to investigate whether differences in
patient specific pharmacokinetic properties, both dynamic and absolute, reveal
the difference in response to lithium treatment. The pharmacokinetic properties
which will be assessed are the absminLi, t1/2 and 12h-Li. In addition, the
lithium concentration during an attack will be compared to a contol
measurement, Licontrol.
Study design
This is an observational study in which cluster headache patients with and
without attacks under lithium prophylaxis are included.
Study burden and risks
After the vena puncture, a bruise or hematome can form at the injection site.
The patients can have little wounds or crusts from the finger pricks.
witbreuksweg 397 116
7522 ZA Enschede
NL
witbreuksweg 397 116
7522 ZA Enschede
NL
Listed location countries
Age
Inclusion criteria
Diagnosed with cluster headache according to "The International Classification of Headache Disorders, 2nd Edition". The patients should have a stable lithium intake for at least 3 weeks.
Exclusion criteria
Patients with significant renal disease which may interfere with the study, or patients with other significant neurological or disabling diseases than CH, are excluded from this study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34136.058.10 |