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

Phase 1

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

• Registration Number: EUCTR2015-003513-24-IT
• Lead Sponsor: INTEC PHARMA LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-05
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

1. Subjects 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. Subjects who have a good response to levodopa in the opinion of the
investigator
3. Subjects 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 subject and /or partner include: True abstinence when
this is in line with the preferred and usual lifestyle of the subject, 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