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

• Register: EUCTR
• Last refreshed on: 16 September 2024
• Main ID: EUCTR2015-003513-24-HU
• Date of registration: 02/03/2016
• Prospective Registration: Yes
• Primary sponsor: Intec Pharma, Ltd.
• Public title: OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004
• Scientific title: An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
• Date of first enrolment: 24/05/2016
• Target sample size: 460
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003513-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Germany, Hungary, Israel, Italy, Poland, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Affairs
• Affiliation: Intec Pharma, Ltd.

• Name: Clinical Affairs
• Affiliation: Intec Pharma, Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Men or women with PD and who successfully completed the core study IN 11 004
2. Subjects for whom, in the opinion of the Investigator, the PD diagnosis is still valid and subjects remain eligible for LD therapy
3. Subjects able to understand and sign written 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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 320

Exclusion criteria:
1. Participation in another clinical trial and receipt of an investigational medication within 28 days prior to the planned start of treatment (prior participation in IN 11 004 clinical trial is required)
2. Previous or planned functional neurosurgical treatment for PD (e.g., procedures including ablation or deep brain stimulation) during study participation
3. Concomitant non-steroidal anti-inflammatory drugs (NSAID’s) and oral steroids within 90 days prior to Baseline Visit or planned concomitant administration during study participation
4. Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation.
5. Catechol-O-methyltransferase (COMT) inhibitors within 14 days prior to Baseline Visit or planned administration during study participation
6. Opioids within 7 days prior to Baseline Visit or planned administration during study participation
7. In the opinion of the Investigator, subject should not participate in the study



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

MedDRA version: 19.0 Level: HLT Classification code 10034005 Term: Parkinson's disease and parkinsonism System Organ Class: 100000004852

Intervention(s)

Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: End of Study (Week 53)

Secondary Objective: Not applicable

Primary end point(s): 1. Change from Baseline to End of Study (Week 53) in Unified Parkinson's Disease Rating Scale (UPDRS) scale (with Part III to be evaluated in “on state”.
2. Change from baseline to End of Study in Parkinson’s disease Questionnaire – 39 items (PDQ-39).
3. Improvement as recorded on Clinical Global Impression-Improvement (CGI-I) scale – patient and physician

Main Objective: To determine the long-term clinical benefit and safety of AP-CD/LD in subjects with advanced PD who completed the core study IN 11 004.

Secondary Outcome(s)

Secondary end point(s): Safety and Tolerability Outcome Measures:
1. Adverse Events
2. Safety laboratory
3. Vital signs
4. Electrocardiogram (ECG)
5. Physical examination
6. Orthostatic hypotension evaluation
7. Withdrawal rates, days and reason to withdrawals

Timepoint(s) of evaluation of this end point: On an ongoing basis.

Secondary ID(s)

NCT02615873

IN11004OLE

Source(s) of Monetary Support

Intec Pharma, Ltd.

Ethics review

Status: Approved
Approval date: 11/05/2016
Contact: