Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2008-001329-33-GB
• Date of registration: 15/03/2010
• Prospective Registration: Yes
• Primary sponsor: AbbVie Inc
• Public title: Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
• Scientific title: Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies.
• Date of first enrolment: 24/02/2011
• Target sample size: 275
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001329-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Czech Republic, Israel, Italy, New Zealand, Poland, Portugal, Russian Federation, Thailand, United Kingdom

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion criteria:
In order to be eligible to participate in this study, subjects must meet the following criteria:

1. The subject should have completed participation in Study S187.3.003, S187.3.004, or any new Phase 3 open-label LCIG study initiated by the Sponsor; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG. For Canada, subjects will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.

2. The subject must understand the nature of the study and must provide written
informed consent prior to the conduct of any study related procedures.
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 137
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 138

Exclusion criteria:
Subjects meeting any of the exclusion criteria listed below at baseline must be excluded from participation in the study.
1. Medical, laboratory, psychiatric, or surgical issues deemed by the Investigator to be clinically significant, and which could confound the findings of the study, or interfere with the subject’s participation in the study.


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

Health Condition(s) or Problem(s) studied

Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies
MedDRA version: 16.0 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852

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

Intervention(s)

Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel
Pharmaceutical Form: Gel
INN or Proposed INN: levodopa
CAS Number: 59-92-7
Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: carbidopa monohydrate
CAS Number: 38821-49-7
Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Secondary Objective: To assess the long-term safety and tolerability of the LCIG therapeutic system by the
following:
? Physical examination, including weight
? Neurological examination
? Vital signs
? Resting ECGs
? Columbia Suicide-Severity Rating Scale (C-SSRS)
? Clinical laboratory assessments including biochemistry, hematology,
urinalysis, and special labs to monitor for vitamin deficiencies
? Concomitant medication usage
? Adverse event monitoring, including for the development of sleep attacks,
melanoma, or excessive impulsive behavior
? Monitoring complications of the infusion device
? Tolerability assessed by number of subjects who complete the study

Main Objective: The primary objective of this study is to provide, under well-controlled conditions,
continued access to LCIG treatment to subjects who have already participated in an
open-label efficacy and safety trial with the same treatment (S187.3.003, S187.3.004, or
any new Phase 3 open-label LCIG study initiated by the Sponsor), and in whom the need
for such continuation is indicated, as confirmed by periodic evaluation, until the product
is commercially available.

Primary end point(s): Safety and Tolerability Assessments:

1. Adverse event monitoring (including sleep attacks, development of impulsive behavior and of melanoma)
2. Monitoring complications of the infusion device

Efficacy Assessments (for the subject’s continuity in the study):

1. Periodic assessment of the appropriateness for continuation in the study. The decision to continue is based on the Principle Investigator’s clinical judgment.

Timepoint(s) of evaluation of this end point: Until commercial availability

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Until commercial availability

Secondary end point(s): Evaluation of physical exams, neurological exams, vitals, ECGs, clinical lab assessments, concomitant medication usage, monitoring complications of the infusion device, adverse event monitoring, tolerability assessed by the number of subjects who complete the study.

Secondary ID(s)

NCT00660673

2008-001329-33-PT

S187.3.005

Source(s) of Monetary Support

AbbVie Inc

Ethics review

Status: Approved
Approval date:
Contact: