T-Port to apply Duodopa.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR934
• Date of registration: 13/03/2007
• Primary sponsor: TransCutan AB
• Public title: T-Port to apply Duodopa.
• Scientific title: Transcutaneous port (T-Port) for gastrostomy use in combination with Duodopa. - TEPODOPA
• Date of first enrolment: 1/5/2007
• Target sample size: 10
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=934
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: 2 or more arms, non-randomized

Countries of recruitment

The Netherlands

Contacts

• Name: K.L. Leenders

• Name: K.L. Leenders

Key inclusion & exclusion 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: 1. Non-responsiveness to levodopa substitution therapy;

2. Deformities abdominal wall.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Parkinson's disease

Intervention(s)

Insertion in abdominal wall titanium T-Port en insertion of duodenum tube.

Primary Outcome(s)

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 ID(s)

2007/072

Source(s) of Monetary Support

Solvay Pharmaceuticals GMBH