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-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas
- Conditions
- Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.Tratamiento de la enfermedad de Parkinson avanzada que responde a Levidopa con fluctuaciones motoras severasMedDRA version: 9.1Level: LLTClassification code 10013113Term: Disease Parkinson's
- Registration Number
- EUCTR2006-005186-18-ES
- Lead Sponsor
- Solvay Pharmaceuticals B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
1. 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
10. Females who are not breast-feeding or are of non-childbearing potential may be enrolled. All females 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. bilateral tubal sterilization) at least three months prior to baseline, or
-total hysterectomy at least three months prior to baseline
11. A female subject of child-bearing potential may be enrolled provided that she is maintained on a medically acceptable method of birth control.
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
Subjects meeting any of the exclusion criteria listed below either at screening and/or baseline must be excluded from participation in the study.
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;
10. Alzheimer’s disease; or other significant cognitive impairment or dementia (defined as Mini-Mental State Examination [MMSE] <24);
11. Clinically significant abnormal laboratory data (e.g., aspartate aminotransferase [AST] or alanine aminotransferase [ALT] greater than three times the upper limit of normal) or any 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 medication 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 five 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, laboratory or surgical issues deemed by the investigator to be clinically significant;
16. Exposure to any investigational drug within 30 days prior to baseline;
17. Prior exposure to levodopa-carbidopa gel;
18. Uncooperative attitude or reasonable likelihood for non-comp
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method