Levodopa and Pramipexole dministration modalities in patients affected by parkinson desease.

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2010-019396-29-IT
• Date of registration: 05/03/2012
• Prospective Registration: No
• Primary sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO-VITTORIO EMANUELE
• Public title: Levodopa and Pramipexole dministration modalities in patients affected by parkinson desease.
• Scientific title: Levodopa Administration Modalities and Pramipexole in Parkinson's Disease (LAMP-PD study) A multicenter, randomized, four parallel groups, active-controlled, open-label study to evaluate the risk of dyskinesia in early PD. - LAMP-PD
• Date of first enrolment: 18/05/2010
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019396-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: - same IMP used at different dosage Number of treatment arms in the trial: 4

Countries of recruitment

Italy

Contacts

• Name: Dipartimento di Neurologia
• Affiliation: AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO -VITTORIO EMANUELE

• Name: Dipartimento di Neurologia
• Affiliation: AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO -VITTORIO EMANUELE

Key inclusion & exclusion criteria

Inclusion criteria:
1.Idiopathic PD diagnosed according to the Gelb’s criteria; 2.Aged between 50-74 years; 3.Hoehn Yahr stage 1-2.5; 4.Ascertained dopaminergic response; 5.Willing and able to give written informed consent; 6.Willing and able to comply with the study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms; 2.History of stereotaxic brain surgery for PD; 3.Mini-mental examination (MMSE) score less than 24 at screening; 4.Previous use of LD in any formulation for more than 3 months or for any time within 4 week prior to baseline; 5.Previous use of a DAs in any formulation for more than 3 months or for any time within 4 week prior to baseline; 6.Presence of dyskinesia prior to baseline; 7.Any other medical or psychiatric condition that may compromise the patient’s participation in this study; 8.Women with child-bearing potential; 9.History of known hypersensitivity to any of the study drugs; 10.Who for any reason would be expected to be unable to complete the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with idiopathic Parkinson's Disease.

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 125-

Trade Name: COMTAN
Pharmaceutical Form: Tablet
INN or Proposed INN: Entacapone
Concentration unit: mg milligram(s)
Concentration number: 200-

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 125-

Trade Name: STALEVO*100CPR 50/12,5/200MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor
Concentration unit: mg milligram(s)
Concentration number: 262.5-

Trade Name: STALEVO*100CPR 100/25/200MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor
Concentration unit: mg milligram(s)
Concentration number: 325-

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 275-

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 275-

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 275-

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 275-

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 125-

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 125-

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 125-

Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Conce

Primary Outcome(s)

Secondary Objective: 1.Severity of dyskinesia; 2.Effect of treatments on the parkinsonian disability; 3.Effect of treatments on quality of life; 4.Effect of treatments on the progression of PD; 5.Incidence of wearing off; 6.Time to loss of the LDR; 7.Cumulative daily dosage of LD or Pramipexole needed to maintain an optimal LDR; 8.Percentage of patients requiring supplemental LD; 9.Incidence of adverse events; 10.Incidence of Impulsive Control disorder.

Main Objective: To evaluate the risk of dyskinesia in early PD patients treated with different modalities of LD administration (CLD, PLD and ILD) or pramipexole over a period of two years (24 months).

Primary end point(s): The primary outcome variable is defined as the time until the occurrence of dyskinesia. Dyskinesia will be considered to be present if a patient had a score of 1 or more at Unified Parkinson’s Disease Rating Scale (UPDRS) item 32 during any visit. Dyskinesia will be also assessed by blinded raters at the peak of the drug maximal efficacy by mean of Abnormal Involuntary Movements Scale (AIMS) and Clinical Dyskinesia Rating Scale (CDRS). Dyskinesia will be considered to be present if a patient had a score greater than 0.

Secondary ID(s)

LAMP-PD

Source(s) of Monetary Support

AIFA (bandi per la ricerca indipendente)