EUCTR2005-001006-12-DE
Active, not recruiting
Phase 1
Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO
Axxonis Pharma GmbH0 sites60 target enrollmentSeptember 5, 2006
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.
- Sponsor
- Axxonis Pharma GmbH
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female patients
- •Age 18 \- 75 years
- •Idiopathic Parkinson’s disease for at least 3 years (diagnosis based on the UK Brain Bank Criteria)
- •Presence of motor fluctuations (wearing\-off or other OFF periods) and / or presence of troublesome dyskinesia, with a total daily minimum of at least 4 hours, despite optimized oral anti\-parkinsonian therapy
- •Stable levodopa intake, i.e. at least four doses of levodopa per day
- •Stable dosing of all other anti\-parkinsonian drugs, such as dopamine agonists, COMT\- and MAO\-B inhibitors, amantadine, or anticholin\-ergics for a minimum of four weeks prior to inclusion.
- •The following oral dopamine agonist drugs are allowed in this trial: pramipexol up to a total daily dose of 3,15mg, ropinirol up to a total daily dose of 24mg, cabergoline up to a total daily dose of 6mg or combinations
- •Concomitant diseases are stable and well controlled
- •Willingness and ability to comply with all trial requirements
- •Written informed consent
Exclusion Criteria
- •Non\-idiopathic Parkinson’s disease (e.g. drug\-induced or other forms of secondary or atypical parkinsonism such as MSA)
- •Significant neurological symptoms not accounted for by Parkinson’s disease
- •History or presence of dementia according to clinical impressions
- •Mini\-mental status examination (MMSE \< 24\)
- •Presence of major depression according to DSM IV criteria (\= 6 months)
- •History or presence of epilepsy
- •Presence of dopaminergic psychosis
- •Unstable severe concomitant diseases (e.g. liver diseases, kidney diseases or clinically relevant cardiac or coronary dysfunction)
- •Presence of heart valvular fibrosis or indication of significant valvular stenosis / insufficiency on echocardiogram
- •History of syncope and/or severe or otherwise symptomatic orthostatic hypotension
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSOPatients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.MedDRA version: 9.1Level: LLTClassification code 10034006Term: Parkinson's disease aggravatedEUCTR2005-001006-12-CZAxxonis Pharma GmbH60
Active, not recruiting
Not Applicable
Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSOPatients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.EUCTR2005-001006-12-ATAxxonis Pharma GmbH60
Completed
Phase 3
To prove the therapeutic efficacy and tolerability of Ichthraletten® versus placebo in case of mild to moderate Acne papulopustulosa.CTRI/2009/091/000791ICHTHYOLCompany Cordes Hermanni and Co120
Active, not recruiting
Not Applicable
Double-blind, placebo controlled, randomized, multicenter, parallel-group study to compare the efficacy and safety of Advantan cream twice weekly with Advabase cream during a maintenance phase of 16 weeks after successful treatment of Atopic Dermatitis with Advantan creamAtopic DermatitisMedDRA version: 6.1Level: PTClassification code 10012438EUCTR2004-002673-22-ITSCHERING
Active, not recruiting
Not Applicable
Double-blind, placebo controlled, randomized, multicenter, parallel-group study to compare the efficacy and safety of Advantan cream twice weekly with Advabas cream during a maintenance phase of 16 weeks after successful treatment of Atopic Dermatitis with Advantan cream - Advantan maintenance studyAtopic DermatitisMedDRA version: 7.1Level: PTClassification code 10012438EUCTR2004-002673-22-DESchering AG250