- Is the apomorphine micro-emulsion effective and safe?- Does iontophoresis improve the clinical effect and safety of the micro-emulsion?- Does surfactant improve the effectiveness of the micro-emulsion with iontophoresis without changing the safety…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical improvement
- tapping score
- standard scales for clinical improvement
side-effects
-scales
-visual scoringsystem
Secondary outcome
apomorphine plasma concentration
Background summary
The majority of patients with Parkinson*s disease experience a decrease in the
effectiveness of their levodopa treatment after a couple of years. This results
in *on-off* fluctuations. Until recently no effective treatment for this
phenomenon has been found. Apomorphine has proved to be useful, however, a
means for continuous administration is still to be established. At this moment
adequate plasma levels can be attained with transdermal administration of an
apomorphine micro-emulsion. Iontophoresis could be useful in elevating these
levels and could offer potential for an accurate regulation.
Study objective
- Is the apomorphine micro-emulsion effective and safe?
- Does iontophoresis improve the clinical effect and safety of the
micro-emulsion?
- Does surfactant improve the effectiveness of the micro-emulsion with
iontophoresis without changing the safety
Study design
The patients are asked to spend three separate days in the UMCG. They are
consecutively treated with transdermal apomorphine micro-emulsion (AME), AME
plus iontophoresis and subsequently with AME iontophoresis and surfactant. For
internal control they are also treated with apomorphine intravenously.
The clinical effect will be determined by unilateral tapping scores and
standard scales for clinical improvement. Local and general side effects are
determined by questionnaires and local dermal side effects by a visual scoring
system.
Study burden and risks
Earlier research has pointed out that transdermal apomorphine delivery does not
cause any risks. Concerning iontophoresis there is the possibility of some
slight local side effects. This includes itching en tingling. Some mild
erythema can occur, which will disappear spontaneously. Iontophoresis does not
cause pain.
Five ml of blood will be drawn through an infuse approximately twenty times a
day. Furthermore the patient will be given a subcutaneous apomorphine
injection and has to spend three separate days in the hospital.
postbus 30.001
9700 RB Groningen
Nederland
postbus 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
- Patients with parkinson's disease with at random fluctuations that are insufficiently medicated with oral parkinson medication
-age > 18
-patient signed approved informed consent;-patient should be capable of understanding the protocol
Exclusion criteria
- severe reaction on subcutaneous apomorphine test
-little skin pigmentation combined with burned skin
-instable internal pathology
-changes in parkinson medication during the past month
-Mini Mental State Examination <24
- Orthostatic hypotension
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 |
|---|---|
| EudraCT | EUCTR2006-005639-11-NL |
| CCMO | NL14725.042.06 |