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.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety:
To assess the safety and tolerability:
* Adverse event monitoring.
* Tolerability assessed by number of subjects who complete the 6 months of
treatment
* Acceptance of the T-Port by the patients
In addition:
• Physical examination, including weight.
• Vital signs systolic/diastolic blood pressure and pulse rate.
• Concomitant medication usage.
• Monitoring complications of the infusion device.
Utility:
Utility will be assessed using the UPDRS, TRS (treatment rating scale) and
PDQ-8
Secondary outcome
NvT
Background summary
Transcutaneous Port (T-Port) for Gastrostomy Use in Combination with Duodopa®
This is a 6 month, open-label, study of the safety and tolerability of
implanting a T-Port for gastrostomy in approximately 10 patients receiving
Duodopa, who have been shown to have levodopa-responsive Parkinson's disease,
with persistent severe motor fluctuations despite optimized treatment with
available Parkinson medicinal products.
Duodopa is delivered to the upper intestine through a catheter inserted via
percutaneous endoscopic gastrostomy (PEG). Gastrostomy will be aided with use
of the transcutaneous titanium port (T-Port). The Duodopa infusion system
consists of a suspension which is dispensed in medication cassette reservoirs
designed to be connected to a portable pump. The contents of the medication
cassette reservoir are delivered via continuous administration over a sixteen
hour period. Additional bolus doses can be given to address immediate medical
needs.
The reference therapy will be the PEG-duodenal/jejunal tube applied which until
recently is the standard Duodopa approach. The disadvantages of the PEG methods
are mainly: leakage problems, dislocation of tube into the stomach, blocking
problems. Also cosmetic and handling disadvantages are mentioned by the
patients. The dose of Duodopa and the administration by the pump will be
identical in the T-Port system.
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
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 burden and risks
The burden of the project is almost identical to the conventional PEG duodenum
therapy. In addition the patient has to wait 2 weeks before the Duodopa
infusion can be started instead of immediate infusion after the PEG tube has
been placed.
Also the patient has to come to the out-patient clinic 6 times during 6 months
after implantation of the T-Port. After PEG tube positioning the patient
usually has to return to the out-patient clinic only 3 or 4 times within the
first 6 months, provided no complications are encountered.
Risks: local hematoma or infection in the abdominal wall.
Björnflokevägen 35
S-162 45 Vällingby
Zweden
Björnflokevägen 35
S-162 45 Vällingby
Zweden
Listed location countries
Age
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
non-responsiveness to levodopa substitution therapy. Deformities abdominal wall.
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 | NL16049.042.07 |
| Other | Nog niet bekend. |