An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications

An Open-Label Three-Part Extension Study Assessing Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications

This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.

Study Overview

• Status: Completed
• Conditions: Advanced Parkinson's Disease
• Intervention / Treatment: Drug: ABT-SLV187

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Sakyo-ku, Japan, 606-8507
    • Kyoto University Hospital /ID# 112136
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-8644
      • National Hospital Organization Asahikawa Medical Center /ID# 101178
  • Kanagawa
    • Sagamihara-shi, Kanagawa, Japan, 252-0315
      • National Hospital Organization Sagamihara National Hospital /ID# 98662
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0871
      • Osaka University Hospital /ID# 108335
  • Tokyo
    • Kodaira, Tokyo, Japan, 187-8551
      • National Center of Neurology and Psychiatry /ID# 98664
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 105935
• Taiwan
  • Taoyuan City, Taiwan, 33305
    • Linkou Chang Gung Memorial Ho /ID# 102297

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects completing 12 weeks treatment in Study M12-921 who would benefit from long-term treatment from ABT-SLV187. Alternatively, subjects who (i) participated in the Phase 2 Study M12-925 (ii) would, in the opinion of the Investigator, benefit from ABT-SLV187 treatment in the Study M12-923, (iii) did not discontinue the M12-925 Study due to safety reason, and (iv) meet all entry requirements. Lastly, subjects who completed another ABT-SLV187 study (e.g., Study M12-927) in South Korea.
2. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
3. The subject must be willing to continue on treatment.

Exclusion Criteria:

1. Subject is enrolled in another clinical trial.
2. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
3. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant and in the opinion of the PI, would be a contraindication to continued levodopa therapy.
4. Uncooperative attitude or reasonable likelihood for non-compliance with the protocol.
5. Subject has current significant suicidal ideation as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale completed at the Week 12 Visit of Study M12-921 or at the Baseline Visit of the current study for M12-925 or M12-927 study subjects.
6. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-SLV187.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABT-SLV187; up to 6 years	Drug: ABT-SLV187; Dose levels will be individually optimized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	All negative changes in health during the study will be treated and recorded during the study.	From Day 1 up to 6 years (estimated maximum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Global Impression of Change (PGIC) scores	The PGIC is a 7-point response scale. The subject will be asked by the Investigator or qualified designee to rate their change in their disease status.	From Screening Visit 2 of M12-921 to Week 52 of M12-923
Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score	The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the course of Parkinson's disease.	From Day 1 up to 36 months (estimated maximum)
Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores	The PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.	From Screening Visit 2 of M12-921 to Week 52
Change in PD Diary mean daily "On" time without troublesome dyskinesia ("On" time without dyskinesia or with non-troublesome dyskinesia) or "On" time with troublesome dyskinesia	The study will assess the difference in the amount of time a subject is able to move and function well during the day.	From Day 1 to Week 52
Change in the mean daily "Off" time (hours) as measured by the Parkinson's Disease (PD) Diary ©	The study will assess the difference in the amount of time a subject is unable to move and function during the day.	From Day 1 to Week 52
Change in Clinical Global Impression of Change (CGI-C) scores	The 7-item CGI-C (Change) scale assesses the overall degree of illness relative to Week 0. A rating of 4 is equivalent to "no change." Ratings < 4 are equivalent to "improvement" and ratings of 4 are equivalent to "worsening."	From Screening Visit 2 of M12-921 to Week 52 of M12-923

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Murata M, Mihara M, Hasegawa K, Jeon B, Tsai CH, Nishikawa N, Oeda T, Yokoyama M, Robieson WZ, Chatamra K, Facheris MF, Benesh J. Safety and efficacy of levodopa-carbidopa intestinal gel: results from an open-label extension study in Japanese, Korean and Taiwanese patients with advanced Parkinson's disease. Ther Adv Neurol Disord. 2018 Feb 26;11:1756286418759315. doi: 10.1177/1756286418759315. eCollection 2018.

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2014
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: February 14, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (Estimate): March 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Efficacy; levodopa; Tolerability; Advanced Parkinson's Disease; carbidopa; levodopa-carbidopa intestinal gel
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: M12-923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No