26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease

• Register: EUCTR
• Last refreshed on: 21 November 2016
• Main ID: EUCTR2014-004865-26-DE
• Date of registration: 22/05/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease
• Scientific title: An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study
• Date of first enrolment: 27/08/2015
• Target sample size: 88
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004865-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes 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 Number of treatment arms in the trial: 2
• 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, Canada, European Union, Germany, Italy, Spain, Sweden

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject must have a minimum PDSS-2 total score of 20 at Baseline assessment.
2. Subject must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria. See Appendix C for UKPDS.
3. Subject demonstrates persistent motor fluctuations in spite of individually optimized treatment.
4. The subject's Parkinson's disease is levodopa-responsive.
5. Subject has had optimal treatment with available anti-PD medication and their motor symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other antiparkinsonian medication. This will be based on the Investigator's clinical judgment.
6. Subject and/or if applicable, their care-partner must be able to complete the Subject Dosing Diary and must be able to demonstrate the ability to operate, manipulate and care for the infusion pump and tubing.

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 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion criteria:
1. Subject's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g., Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD.
2. Subject has undergone neurosurgery for the treatment of Parkinson's disease.
3. Subject has any neurological deficit that might interfere with the study assessments (e.g., hemiparesis).
4. Known hypersensitivity to levodopa, carbidopa or radiopaque material.
5. Subject has contraindications to levodopa, (e.g., narrow angle glaucoma, malignant melanoma).
6. Subject experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation) as judged by the Principal Investigator.
7.Subject has undergone apomorphine continuous infusion for the treatment of Parkinson's disease


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

Health Condition(s) or Problem(s) studied

Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 19.0 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
Pharmaceutical Form: Intestinal gel
INN or Proposed INN: Levodopa
CAS Number: 59-92-7
Other descriptive name: LEVODOPA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Carbidopa
CAS Number: 38821-49-7
Other descriptive name: CARBIDOPA MONOHYDRATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Secondary Objective: To assess the effect of LCIG relative to that of OMT on the motor symptoms/motor complications, safety, tolerability and health-related outcome measures.

Primary end point(s): Non-Motor Symptoms Scale (NMSS) Total Score and the Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score.

Main Objective: The primary objective of this study is to examine the effect of LCIG relative to that of OMT on non motor symptoms associated with advanced Parkinson's disease.

Timepoint(s) of evaluation of this end point: Baseline, Week 6, Week 12, Week 26

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: UPDRS Parts III and IV:Screening, Baseline, Week6, Week 12, Week 26
Safety and Tolerability: every visit
HEOR: Baseline, Week 6, Week 12, Week 26

Secondary end point(s): Motor symptoms/motor complications will be measured by •Unified Parkinson's Disease Rating Scale (UPDRS) Parts III and IV

Safety and tolerability will be assessed by:
• Adverse event monitoring
• Neurological exams
• Clinical laboratory evaluations
• Electrocardiogram
• Vital signs and weight
• Columbia Suicide Severity Rating Scale (C-SSRS)
• Minnesota Impulsive Disorders Interview (MIDI)
? Sleep Attacks Questionnaire (SAQ)

Health Related Outcomes will be measured by:
• Parkinson's Disease Questionaire-8 (PDQ-8)
• Clinical Global Impression of Change (CGI-C)
• UPDRS Parts I and II
• Patient Global Impression of Change (PGIC)
• Montreal Cognitive Assessment Test (MOCA)
• PD Anxiety Index (PAS)
• Geriatric Depression Scale (GDS-15)
• King PD Pain Scale

Secondary ID(s)

M12-927

Source(s) of Monetary Support

AbbVie Inc.