evodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease

• Conditions: Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.; MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2006-005186-18-DE
• Lead Sponsor: Abbott Healthcare Products B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-13
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1.Diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria;.
2.The subjects' advanced PD must be the Levodopalevodopa-responsive type as judged by the Investigator. Additionally, subjects will need to demonstrate severe motor fluctuations in spite of individually optimized available treatment, and where other therapy options are indicated;.
3.Subjects have had optimal treatment with available PD medication as defined by local standards of care and, based upon the judgment of the Investigator, and their symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of Levodopalevodopa and/or other antiparkinsonian medication; this. This will be based on the Investigator's best clinical judgment;.
4.Presence of a recognizable offOff and onOn state (motor fluctuations) as confirmed by the symptom diaryParkinson's Disease Diary© at baseline (diaries are collected for the 3 days preceding the Baseline visit);.
5.Subjects (or subject's proxy) must be able to keep a subject diaryParkinson's Disease Diary© of offOff time and dyskinesia;. Subjects' entries may be entered by the caregiver.
6.Subjects must be experiencing a minimum of 3 hours per day of offOff time, as estimated by the Investigator and supported by the UPDRS and the diariesParkinson's Disease Diary©. The offOff time must occur during a continuous 16-hour interval, including the portion of the day during which the subject is awake the majority of the time (e.g., 5 AM to 9 PM, 7 AM to 11 PM);.
7.The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen);.
8.Subjects must be able to speak, read, understand and possess the ability to respond to and follow simple instructions. For a subject to be eligible all required documents, including the informed consent, must be available in a language which is understandable to the subject;.
9.Male or female subjects aged at least 30 years; of age.
10.Females who are not breast-feeding or are of non-childbearing potential. All females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-HCG) test prior to study entry.
Non-childbearing is defined as:
?last natural menstruation at least 24 months prior to Baseline or
?surgically sterilized (i.e., tubal sterilization) at least 3 months prior to Baseline or
?total hysterectomy at least 3 months prior to Baseline.
11.A female subject of childbearing potential may be enrolled provided that she is maintained on one of the following medically acceptable methods of birth control (a stable dose of contraceptive drug for at least 3 months or barrier methods: intra uterine device, diaphragm, combination of a condom and spermicide).

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 189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

Subjects meeting any of the exclusion criteria listed below either at screening and/or baseline must be excluded from participation in the study.
1. PD diagnosis is unclear or a suspicion of other parkinsonianParkinsonian syndromes exists, such as secondary parkinsonismParkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson's-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or other neurodegenerative diseases;.
2. Subjects who have undergone surgery for the treatment of PD (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation);.
3. Subjects with any neurological deficit that might interfere with the study assessments (e.g., hemiparesis); and/or any subjects diagnosed with an acute stroke within the 6 months prior to Baseline;.
4. Known hypersensitivity to Levodopa, Carbidopalevodopa, carbidopa or radiopaque material;.
5. Contraindications to Levodopa,levodopa such as narrow angle glaucoma, pheochromocytoma, Cushing's syndrome andor history of malignant melanoma;.
6. Subjects who are experiencing sleep attacks or who exhibit clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality) at any point during the 3 months prior to the screening evaluation;.
7. Current diagnosis or history of drug or alcohol abuse (Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV-TR criteria) within 12 months prior to the Screening visit;.
8. Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses (e.g., such as bipolar disorder or major depressive disorder (per DSM IV-TR criteria);.
9. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct or interpretation of the study; troublesome. Troublesome hallucinations would also be included under this category;.
10. Alzheimer's disease; or other conditions including significant cognitive impairment or dementia (defined as MMSE < 24);.
11. Clinically significant abnormal laboratory data (e.g., aspartate aminotransferase [AST] or alanine aminotransferase [ALT] = 3 × ULN) or any other abnormal laboratory value that could interfere with the assessment of safety. in the judgment of the Investigator;.
12. Current evidence of clinically significant hematological, autoimmune, endocrine, cardiovascular, renal or gastrointestinal disorder that would possibly interfere with the subject's participation in the study (e.g., treated, controlled and thus stable hypertension is not considered an exclusion criterion);.
13. A history of, or a known current gastrointestinal, liver, kidney or other known condition, which may interfere with the absorption, distribution, metabolism or excretion of the study drug and/or assessments, or interfere with the insertion of the tubing system (e.g., subjects who have undergone gastric or intestinal surgery other than, for instance, appendectomy or cholecystectomy);.
14. Any malignant disease or a history of neoplasms, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the past 5 years prior to screening. Additionally, subjects with prostate cancer may be considered for enrollment in the study following a comprehensive assessment and a discussion between the Investigator and the Medical Monitor regarding the appropriateness of the subject for the study;.
15. Medical, labor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified