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)

NCT02549092 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M12-9272014-004865-26
• Study Type: interventional
• Target: 89
• Locations: 9 countries
• Sites: 38

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.

Conditions

Advanced Parkinson's Disease

Keywords

levodopa-carbidopa intestinal gel; levodopa; carbidopa; Advanced Parkinson's Disease; Non-Motor Symptom Scale NMSS; Parkinson's Disease Sleep Scale PDSS-2; efficacy

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Week 26 in the NMSS Total Score

  The NMSS consists of 30 questions in 9 domains (cardiovascular/falls, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, GI tract, urinary, sexual function, miscellaneous). Score of each question is calculated by multiplying severity\*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Total score is the sum of 9 domains, and ranges from 0 to 360, with a lower value indicating a more desirable outcome. Repeated-measure analysis.

  Baseline, Week 26

• Change From Baseline to Week 26 in the Modified PDSS-2 Total Score

  The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 \[never\] to 4 \[very often\]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Repeated measure analysis.

  Baseline, Week 26

Secondary Outcomes (10)

• Change From Baseline to Week 26 in Parkinson's Disease Questionnaire (PDQ-8) Summary Index Score

  Baseline, Week 26

• Clinical Global Impression of Change (CGI-C) Final Score

  End of Treatment Period (up to Week 26)

• Change From Baseline at Week 26 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score

  Baseline, Week 26

• Change From Baseline to Week 26 in the NMSS Domain Scores

  Baseline, Week 26

• Change From Baseline to Week 26 in the Modified PDSS-2 Domain Scores

  Baseline, Week 26

Study Arms (2)

Optimized Medical Treatment (OMT)

ACTIVE COMPARATOR

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.

Drug: Optimized Medical Treatment; Drug: Levodopa-Carbidopa Intestinal Gel; Device: Nasojejunal (NJ) tube; Device: Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

Levodopa-Carbidopa Intestinal Gel (LCIG)

EXPERIMENTAL

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.

Drug: Levodopa-Carbidopa Intestinal Gel; Device: Nasojejunal (NJ) tube; Device: Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

Interventions

Optimized Medical Treatment 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.

Optimized Medical Treatment (OMT)

Levodopa-Carbidopa Intestinal Gel DRUG

Also known as: ABT-SLV187, Duodopa, LCIG

Levodopa-Carbidopa Intestinal Gel (LCIG); Optimized Medical Treatment (OMT)

Nasojejunal (NJ) tube DEVICE

optional prior to PEG-J placement

Levodopa-Carbidopa Intestinal Gel (LCIG); Optimized Medical Treatment (OMT)

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

Levodopa-Carbidopa Intestinal Gel (LCIG); Optimized Medical Treatment (OMT)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant(s) must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria.
• Participant(s) demonstrates persistent motor fluctuations in spite of individually optimized treatment.
• The participant's Parkinson's disease is levodopa-responsive.
• 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.
• Male or female participant(s) must be at least 30 years of age.
• Minimum Parkinson's Disease Sleep Scale 2 (PDSS-2) total score of 18 at Baseline assessment.

You may not qualify if:

• 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.
• Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.
• Known hypersensitivity to levodopa, carbidopa or radiopaque material.
• Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma).
• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (38)

Parkinson's and Movement /ID# 161596

Fountain Valley, California, 92708, United States

Location

Boca Raton Regional Hospital /ID# 200056

Boca Raton, Florida, 33486, United States

Location

University of Florida Neurolog /ID# 168699

Jacksonville, Florida, 32209, United States

Location

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

Port Charlotte, Florida, 33980, United States

Location

Rush University Medical Center /ID# 168088

Chicago, Illinois, 60612, United States

Location

St. Luke's Health System /ID# 168706

Kansas City, Missouri, 64111, United States

Location

Central Texas Neurology Consul /ID# 168087

Round Rock, Texas, 78681, United States

Location

Inland Northwest Research /ID# 200113

Spokane, Washington, 99202-1342, United States

Location

Westmead Hospital /ID# 136575

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital /ID# 136577

Adelaide, South Australia, 5000, Australia

Location

Royal Melbourne Hospital /ID# 136780

Parkville, Victoria, 3050, Australia

Location

Goulburn Valley Hospital /ID# 164202

Shepparton, Victoria, 3630, Australia

Location

University of Alberta /ID# 136586

Edmonton, Alberta, T6G 2X8, Canada

Location

The Ottawa Hospital /ID# 139341

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto Western Hospital /ID# 136585

Toronto, Ontario, M5T 2S8, Canada

Location

Central Hospital Bremerhaven /ID# 136573

Bremerhaven, 27574, Germany

Location

251 Airforce General Hospital /ID# 160594

Athens, Attica, 11525, Greece

Location

Mediterraneo Hospital /ID# 208042

Glyfada, 16675, Greece

Location

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

Ancona, The Marches, 60126, Italy

Location

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

Bologna, 40139, Italy

Location

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

Foggia, 71100, Italy

Location

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

Messina, 98125, Italy

Location

Ospedale S.Maria della Miseri /ID# 160609

Perugia, 06132, Italy

Location

Azienda Sanitaria Locale di /ID# 160608

Ponderano,biella, 13875, Italy

Location

Azienda Policlinico Umberto I /ID# 201223

Roma, 00161, Italy

Location

Severance Hospital /ID# 163019

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Seoul National University Hospital /ID# 162990

Seoul, 03080, South Korea

Location

Asan Medical Center /ID# 163018

Seoul, 05505, South Korea

Location

Hospital Universitario de Bellvitge /ID# 136579

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

CHU Insular-Materno Infantil /ID# 136783

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Hospital Clinic de Barcelona /ID# 137689

Barcelona, 08036, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 136581

Barcelona, 08041, Spain

Location

Hospital Puerta del Mar /ID# 157977

Cadiz, 11009, Spain

Location

Hospital Universitario Virgen de las Nieves /ID# 136583

Granada, 18014, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 136784

Madrid, 28034, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 145624

Seville, 41013, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 136722

Valencia, 46026, Spain

Location

Karolinska Univ Sjukhuset /ID# 135961

Solna, 17176, Sweden

Location

MeSH Terms

Interventions

carbidopa, levodopa drug combination

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 15, 2015
• Study Start: October 26, 2015
• Primary Completion: May 14, 2020
• Study Completion: November 18, 2022
• Last Updated: November 28, 2023
• Results First Posted: June 3, 2021

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

AU (4); GR (2); DE (1); CA (3); ES (9); SE (1); IT (7); KR (3); US (8)