| - candidate number | 2519 |
| - NTR Number | NTR934 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 13-mrt-2007 |
| - Secondary IDs | 2007/072 METc |
| - Public Title | T-Port to apply Duodopa. |
| - Scientific Title | Transcutaneous port (T-Port) for gastrostomy use in combination with Duodopa. |
| - ACRONYM | TEPODOPA |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Parkinson's disease |
| - 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. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | no |
| - group | Parallel |
| - Type | 2 or more arms, non-randomized |
| - Studytype | intervention |
| - planned startdate | 1-mei-2007 |
| - planned closingdate | 31-dec-2007 |
| - Target number of participants | 10 |
| - Interventions | Insertion in abdominal wall titanium T-Port en insertion of duodenum tube. |
| - 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 |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | prof. dr. K.L. Leenders |
| - CONTACT for SCIENTIFIC QUERIES | prof. dr. K.L. Leenders |
| - Sponsor/Initiator | TransCutan AB |
| - Funding (Source(s) of Monetary or Material Support) | Solvay Pharmaceuticals GMBH |
| - Publications | N/A |
| - Brief 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. |
| - Main changes (audit trail) | |
| - RECORD | 13-mrt-2007 - 1-feb-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl