Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa ? Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations - ND

• Conditions: Parkinson Disease; MedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease

• Registration Number: EUCTR2006-005186-18-IT
• Lead Sponsor: Solvay Pharmaceuticals BV.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-14
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Diagnosis of idiopathic Parkinson?s disease according to the United Kingdom Parkinson?s Disease Society (UKPDS) Brain Bank Criteria with the diagnosis made at least 2 years prior to enrollment in the study.
2. The subject?s Parkinson?s disease must be the levodopa-responsive type as judged by the investigator; additionally, subjects will need to demonstrate severe motor fluctuations in spite of individually optimized oral treatment, and where other therapy options beside oral treatment 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, are judged inadequately controlled on this optimized treatment.
4. Presence of a recognizable ?off? and ?on? state (motor fluctuations) as confirmed by diary at baseline (diary measurements performed for the three days preceding the baseline visit).
5. Subjects or subject?s proxy/caretaker must be able to keep a subject diary of ?off? time.
6. Minimum ?off? time must be approximately 3 hours per day as estimated by the investigator.
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 in their native language and/or in English. All required documents, including the informed consent, will be translated into the native language as appropriate.
9. Male or female subjects aged at least 30 years

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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

1.Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or the 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);
4.Treatment with prohibited medications (see Section 7.8);
5.Known hypersensitivity to levodopa, carbidopa or radiopaque material;
6.Contraindications to levodopa, such as narrow angle glaucoma, hyperthyroidism, pheochromocytoma, Cushing?s syndrome and history of malignant melanoma;
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 screening visit;
8.Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder (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 hallucinations would also be included under this category;

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Study & Design

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