1. Parkinson's disease (NLD: ziekte van Parkinson)
Conditions
Interventions
Insertion in abdominal wall titanium T-Port en insertion of duodenum tube.
Sponsors
TransCutan AB
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Non-responsiveness to levodopa substitution therapy; 2. Deformities abdominal wall.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactK.L. Leenders
Hanzeplein 1
Outcome results
None listed