A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)

NCT ID: NCT02549092

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-26
• Study Completion Date: 2022-11-18

Brief Summary

The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.

Detailed Description

The study will consist of 3 sequential parts:

Part 1: Screening period. The screening period will consist of 3 visits, Visit 1 (V1), Visit 2 ([V2] [optional]) and the Randomization Visit (V3) in which the participant will be assessed to determine eligibility. The duration of the Screening Period can be between 30 to 67 days to accommodate the required procedures, training and collection of diaries, and to allow for stabilization of anti-PD medications and medications to treat NMS. All anti-PD medications and medications to treat NMS are required to be stable for a minimum of 30 days prior to randomization.

Part 2: Treatment period. Those participants randomized to OMT at the end of V3 will remain on their current optimized regimen. The day after randomization will be considered Day 1 of their treatment period and participants will have study visits at the end of Weeks 2, 6, 12, and 26. All participants randomized to the LCIG group should have all anti-PD medications, with the exception of levodopa formulations, tapered off within 14 days after randomization. Optional nasojujunal (NJ) and/or percutaneous endoscopic gastrostomy with a jejunal tube (PEG-J) placement will then occur. After that, the participant may begin initiation and titration of LCIG infusion to be adjusted to obtain the optimal clinical response. The day of initial NJ or PEG-J placement will be considered Day 1 for participants in the LCIG group. Study visits happen at the end of Weeks 2, 6, 12, and 26.

Part 3: Extension/Transition Period. Eligible participants who complete the 26 week study may continue into the Extension Period of the study. Participants in the LCIG arm will have study drug dispensation every 4 weeks and will have study visits every 6 months. Participants from the OMT arm will undergo the NJ (optional) and PEG-J procedures, titration, plus have visits at 2 weeks, 6 weeks, 3 months and 6 months post NJ or PEG-J. Participants will then continue to receive study drug every 4 weeks and will have study visits every 6 months until Duodopa is commercially available. Transition to a Post-Trial Access protocol will be possible if Duodopa does not become commercially available in a location.

Conditions

Advanced Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimized Medical Treatment (OMT)

Participants randomized to continue OMT remain on their current optimized regimen. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.

Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG.

Group Type: ACTIVE_COMPARATOR

Optimized Medical Treatment

Intervention Type: DRUG

Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications.

Levodopa-Carbidopa Intestinal Gel

Intervention Type: DRUG

Nasojejunal (NJ) tube

Intervention Type: DEVICE

optional prior to PEG-J placement

Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

Intervention Type: DEVICE

Levodopa-Carbidopa Intestinal Gel (LCIG)

Participants randomized to LCIG at an individually optimized dose (after NJ and/or PEG-J placement), in accordance with the LCIG approved product label for countries participating in the study. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.

The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion is expected to run over a period of 16 consecutive hours each day.

Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG.

Group Type: EXPERIMENTAL

Levodopa-Carbidopa Intestinal Gel

Intervention Type: DRUG

Nasojejunal (NJ) tube

Intervention Type: DEVICE

optional prior to PEG-J placement

Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

Intervention Type: DEVICE

Interventions

Optimized Medical Treatment

Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications.

Intervention Type: DRUG

Levodopa-Carbidopa Intestinal Gel

Intervention Type: DRUG

Nasojejunal (NJ) tube

optional prior to PEG-J placement

Intervention Type: DEVICE

Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

Intervention Type: DEVICE

Other Intervention Names

ABT-SLV187; Duodopa; LCIG

Eligibility Criteria

Inclusion Criteria

1. Participant(s) must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria.

2. Participant(s) demonstrates persistent motor fluctuations in spite of individually optimized treatment.

3. The participant's Parkinson's disease is levodopa-responsive.

4. Participant(s) has had optimized 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.

5. Male or female participant(s) must be at least 30 years of age.

6. Minimum Parkinson's Disease Sleep Scale 2 (PDSS-2) total score of 18 at Baseline assessment.

Exclusion Criteria

1. Participant'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. Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.

3. Known hypersensitivity to levodopa, carbidopa or radiopaque material.

4. Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma).

5. Participant(s) 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

Parkinson's and Movement /ID# 161596

Fountain Valley, California, United States

Boca Raton Regional Hospital /ID# 200056

Boca Raton, Florida, United States

University of Florida Neurolog /ID# 168699

Jacksonville, Florida, United States

Parkinson's Disease Treatment Center of Southwest Florida /ID# 168085

Port Charlotte, Florida, United States

Rush University Medical Center /ID# 168088

Chicago, Illinois, United States

St. Luke's Health System /ID# 168706

Kansas City, Missouri, United States

Central Texas Neurology Consul /ID# 168087

Round Rock, Texas, United States

Inland Northwest Research /ID# 200113

Spokane, Washington, United States

Westmead Hospital /ID# 136575

Westmead, New South Wales, Australia

Royal Adelaide Hospital /ID# 136577

Adelaide, South Australia, Australia

Royal Melbourne Hospital /ID# 136780

Parkville, Victoria, Australia

Goulburn Valley Hospital /ID# 164202

Shepparton, Victoria, Australia

University of Alberta /ID# 136586

Edmonton, Alberta, Canada

The Ottawa Hospital /ID# 139341

Ottawa, Ontario, Canada

Toronto Western Hospital /ID# 136585

Toronto, Ontario, Canada

Central Hospital Bremerhaven /ID# 136573

Bremerhaven, , Germany

251 Airforce General Hospital /ID# 160594

Athens, Attica, Greece

Mediterraneo Hospital /ID# 208042

Glyfada, , Greece

A.O. Univ. Ospedali Riuniti /ID# 135964

Ancona, The Marches, Italy

Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 136789

Bologna, , Italy

A.O.U. Ospedali Riuniti di Fog /ID# 136792

Foggia, , Italy

A.O.U. Policlinico G. Martino /ID# 136790

Messina, , Italy

Ospedale S.Maria della Miseri /ID# 160609

Perugia, , Italy

Azienda Sanitaria Locale di /ID# 160608

Ponderano,biella, , Italy

Azienda Policlinico Umberto I /ID# 201223

Roma, , Italy

Severance Hospital /ID# 163019

Seoul, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital /ID# 162990

Seoul, , South Korea

Asan Medical Center /ID# 163018

Seoul, , South Korea

Hospital Universitario de Bellvitge /ID# 136579

L'Hospitalet de Llobregat, Barcelona, Spain

CHU Insular-Materno Infantil /ID# 136783

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Clinic de Barcelona /ID# 137689

Barcelona, , Spain

Hospital Santa Creu i Sant Pau /ID# 136581

Barcelona, , Spain

Hospital Puerta del Mar /ID# 157977

Cadiz, , Spain

Hospital Universitario Virgen de las Nieves /ID# 136583

Granada, , Spain

Hospital Universitario Ramon y Cajal /ID# 136784

Madrid, , Spain

Hospital Universitario Virgen del Rocio /ID# 145624

Seville, , Spain

Hospital Universitario y Politecnico La Fe /ID# 136722

Valencia, , Spain

Karolinska Univ Sjukhuset /ID# 135961

Solna, , Sweden

Countries

United States; Australia; Canada; Germany; Greece; Italy; South Korea; Spain; Sweden

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-004865-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M12-927

Identifier Type: -

Identifier Source: org_study_id