OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004

Phase 1

• Conditions: MedDRA version: 20.0 Level: HLT Classification code 10034005 Term: Parkinson's disease and parkinsonism System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-003513-24-BG
• Lead Sponsor: Intec Pharma, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 266

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

1. Participation in a clinical trial other than study IN 11 004 and receipt of an investigational medication other than those administered in study IN 11 004, within 28 days prior to the planned start of treatment
2. Previous or planned functional neurosurgical or Duodopa 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. If, 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 a medically acceptable method 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 > 2years) 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.

Study & Design

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