No registrations found.
ID
Source
Brief title
Health condition
1. Parkinson's disease (NLD: ziekte van Parkinson);
2. T-Port;
3. Duodopa.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To assess the safety and tolerability:
a. Adverse event monitoring;
b. Tolerability assessed by number of subjects who complete the 6 months of treatment;
c. Acceptance of the T-Port by the patients;
In addition:
2. Physical examination, including weight;
3. Vital signs systolic/diastolic blood pressure and pulse rate;
4. Concomitant medication usage;
5. Monitoring complications of the infusion device.
Secondary outcome
N/A
Background summary
This is an open study assessing the long-term safety and utility of a new gastrostomy access port for use with Duodopa, in patients in whom a positive test of the clinical response was already conducted with Duodopa administered via a nasoduodenal tube. Only those PD patients are eligible for the T-Port system who on clinical grounds will be proposed to have Duodopa therapy.
Study objective
The primary objective of this test series will be to gain experience and provide long-term safety using a transcutaneous titanium port as an access port for gastrostomy (T-Port) in the context of Duodopa treatment of severely afflicted PD patients.
Study design
N/A
Intervention
Insertion in abdominal wall titanium T-Port en insertion of duodenum tube.
K.L. Leenders
Groningen 9700 RB
The Netherlands
+31 50 361 2175
k.l.leenders@neuro.umcg.nl
K.L. Leenders
Groningen 9700 RB
The Netherlands
+31 50 361 2175
k.l.leenders@neuro.umcg.nl
Inclusion criteria
Clinical diagnosis of advanced Parkinson's disease. On/off phenomena leading to severe disability which can not be regulated by the normal oral drug schemes. A clinical indaction for duodenum Duodopa tretament should have been made by the treating physician.
Exclusion criteria
1. Non-responsiveness to levodopa substitution therapy;
2. Deformities abdominal wall.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL910 |
| NTR-old | NTR934 |
| Other | METc : 2007/072 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |