MedDRA version: 20.0 Level: HLT Classification code 10034005 Term: Parkinson's disease and parkinsonism System Organ Class: 100000004852
Conditions
Interventions
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Sponsors
Intec Pharma, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who successfully completed the core study IN 11 004 and, in the opinion of the Investigator would benefit from long-term treatment with AP-CD/LD 2. Continue to carry the diagnosis of Parkinson's Disease consistent with UK brain bank criteria. 3. Patients who have a good response to levodopa in the opinion of the investigator 4. Patients able and willing to give written (signed and dated) informed consent to participate in the study 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 186
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial other than IN 11 004 and receipt of an investigational medication, other than those administered in IN 11 004, within 28 days prior to the planned start of treatment. 2. Previous or planned functional neurosurgical or Duodepa treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation) 3. Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation. 4. In the opinion of the Investigator, subject should not participate in the study 5. Women who are pregnant or nursing. Women of childbearing potential who are not willing to use medically acceptable methods of contraception. Medically acceptable methods of contraception that may be used by the patient and / or partner include: True abstinence when this is in line with the preferred and usual lifestyle of the patient, oral contraceptive agents, intrauterine devices (IUDs), implantable contraceptives (e.g. Norplant), transdermal hormonal contraceptives (e.g. Ortho-Evra), and injectable contraceptives (e.g., Depo-Provera), condom and / or diaphragm, diaphragm with vaginal spermicide, surgical sterilization (6 months), or postmenopausal females (no menstrual period for > 2 years) or vasectomy (> 6 months). The current contraceptive therapy must be maintained through the end of the study (End of study visit or final follow-up phone visit, whichever is later). Hormonal contraceptive therapy must be a stable dose for at least 90 days prior to first study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety measures: 1. Adverse Events 2. Specific evaluation of GI complaints (Adverse events of special interest) 3. Withdrawal rates, days and reason to withdrawals 4. Safety laboratory (hematology, biochemistry, Vitamin B12, Folic Acid and urinalysis) 5. Vital signs 6. Electrocardiogram (ECG) 7. Physical examination 8. Orthostatic hypotension evaluation 9. Evaluation of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS) baseline (Visit 1) to EOS (Visit 7) visit 10. Assessment of impulse control using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease–Rating Scale (QUIP-RS) 11. Change from baseline (Visit 1) to EOS (Visit 7) visit in the Scales for Outcomes in Parkinson's Disease - Epworth Sleepiness Scale (ESS) ;Main Objective: To determine the long-term safety and tolerability of AP-CD/LD in subjects with advanced PD who completed the core study IN 11 004.;Secondary Objective: The secondary objective is to determine the long-term clinical benefit of AP-CD/LD in subjects with advanced PD who completed the core study IN 11 004.;Timepoint(s) of evaluation of this end point: On an ongoing basis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Outcome Measures: The following efficacy endpoints are pre-defined as secondary endpoints for approximately the first 150 enrolled patients. 1. Change from Baseline to EOS in the percentage and total hours of daily "Off time" during waking hours based on Hauser Home Diary assessments; Total number of "Off " hours normalized to a 16- hour waking day will also be calculated but only a single p-value applicable to both the percentage and hours will be reported. 2. Change from Baseline to EOS in "On time" without troublesome dyskinesia during waking hours 3. Change from Baseline to EOS in the number of daily Levodopa doses 4. CGI-I at EOS as recorded by physician (all enrolled patients) 5. CGI-I at EOS as recorded by patient (all enrolled patients) 6. Change from Baseline in total UPDRS Score (Sum of Parts I-III) 7. Change from Baseline to EOS in UPDRS Part II (Activities of Daily Living) 8. Change from Baseline to EOS in UPDRS Motor Examination (part III - evaluated 2-3 hours after last LD dose) 9. Change from Baseline to EOS in PDQ-39 summary index 10. Change from Baseline to EOS in troublesome dyskinesia 11. Change from Baseline to EOS in "On time" without dyskinesia during waking hours. In addition, the following exploratory efficacy endpoints will be evaluated. • Change from Baseline to EOS in the Parkinson's Disease Sleep Scale (PDSS-2) • Change from Baseline to EOS (hours during waking time) for each diary category not listed as secondary endpoint • Change from Baseline to EOS in the Freezing of Gait | — |
Countries
Bulgaria, Germany, Hungary, Israel, Italy, Poland, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Affairs
Intec Pharma, Ltd.
Outcome results
None listed