A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-005033-11-DE
• Date of registration: 04/01/2008
• Prospective Registration: Yes
• Primary sponsor: CombinatoRx, Inc
• Public title: A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease
• Scientific title: A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease
• Date of first enrolment: 27/03/2008
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005033-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: Sinemet CR

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients who have provided written informed consent which is written in a manner approved by the Institutional Review Board/Ethics Committee
- At least 65% of the subjects should be male
- Ambulatory patients who are 58 to 75 years of age. The study population will consist of patients with a diagnosis of idiopathic Parkinson disease and will meet both of the following criteria:
1. PD, defined with at least two of the following cardinal features: rest tremor, bradykinesia, rigidity with PD diagnosis less than or equal to 5 years.
2. Levodopa-responsive idiopathic Parkinson’s disease (PD) patients receiving carbidopa/levodopa (immediate release or sustained-release forms (or both), optimally managed with levodopa intake of no more than 600 mg/day.
-Evaluable patients will need to have levodopa-induced peak-effect dyskinesias.
- Female patients must not be of childbearing potential (e.g., surgically sterile or be at least one year post-menopausal).
- Patients must be willing and able to abide by the dietary requirements of the study
- Patients must be willing and able to abide by the restrictions on concomitant medication use that are outlined (restrictions to be determined-see section 9.6).
- Patients must be willing to cooperate with study procedures and to be confined within the clinical site’ designated facility overnight, including three consecutive nights.

Are the trial subjects under 18? no
Number of subjects for this age range:
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:
- Clinical evidence of other parkinsonian syndromes, other than Parkinson’s disease (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, lewy body dementia).
-Patients with the “dyskinesia-improvement-dyskinesia” pattern of levodopa responses, or severe wearing-off dystonia will be excluded.
- Patients characterized as Hoehn & Yahr Stages >4, without clinical features of dementia, “freezing” of gait, or other significant neurological abnormalities.
- Positive test for HIV and Hepatitis A, B, and C
- Positive urine drug screen or positive alcohol breathalyzer test.
- Insufficiently controlled hypertension (blood pressure > 160/100)
- Atrial fibrillation, atrial- nodal- or ventricular arrhythmia, ventricular tachyarrhythmia
- History of gastrointestinal surgery or gastrointestinal disease which could affect drug absorption or elimination.
- Presence of clinically significant urinary tract obstruction
- Patients who donated more than 450 mL of blood within 30 days of the administration of study medication
- Patients who have co-morbid neurological or psychiatric disorders (even if they don’t require medications).
- Subjects who are taking medications outlined in Section 9.6.
- Disruptive non-compliance with requirements of the study causing an inability to collect valid and reliable data.
- History of alcohol abuse or drug abuse.
- Smokers of more than 10 cigarettes per day (average of 10 weeks prior to the Screening Visit).
- Patients who have ingested or who have been administered an investigational compound within 30 days prior to first study medication in this study.
- Any condition the clinical investigator deems to be a significant risk to the patient or the scientific integrity of the study.



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

Health Condition(s) or Problem(s) studied

Patients with Parkinson's Disease

Intervention(s)

Product Name: Levodopa-Carbidopa Multilayer Extended Release Tablet
Product Code: Levodopa-Carbidopa XL tablet (M)
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Levodopa
CAS Number: 59-92-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: Carbidopa
CAS Number: 38821-49-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Sinemet® CR
Product Name: Sinemet CR
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Levodopa
CAS Number: 59-92-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: Carbidopa
CAS Number: 38821-49-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: Provide preliminary assessments of the treatment of Parkinson’s disease using a Parkinson’s Disease Diary, tapping speed and tremor score (monitored every 2 hours up to 6 hours after test doses)

Main Objective: Assess the safety of Levodopa-Carbidopa XL Tablets in subjects with Parkinson's disease
Assess the bioavailability and pharmacokinetics of 2 regimens of Levodopa-Carbidopa XL Tablets in subjects with Parkinson’s disease.

Primary end point(s): Safety of Levodopa-Carbidopa XL Tablets in subjects with Parkinson's disease.
Assess the bioavailability and pharmacokinetics of Levodopa-Carbidopa XL Tablets after a single dose in subjects with Parkinson’s disease.

Secondary ID(s)

SRx-501-01