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

NCT02082249 | Completed Phase 3

• 1 other identifier: M12-923
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 7

Brief Summary

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

Conditions

Advanced Parkinson's Disease

Keywords

Safety; Tolerability; Efficacy; levodopa-carbidopa intestinal gel; levodopa; carbidopa; Advanced Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Patient Global Impression of Change (PGIC) scores

  From Screening Visit 2 of M12-921 to Week 52 of M12-923

• Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score

  From Day 1 up to 36 months (estimated maximum)

• Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores

  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

  From Day 1 to Week 52

• Change in the mean daily "Off" time (hours) as measured by the Parkinson's Disease (PD) Diary ©

  From Day 1 to Week 52

Study Arms (1)

ABT-SLV187

EXPERIMENTAL

up to 6 years

Drug: ABT-SLV187

Interventions

ABT-SLV187 DRUG

Dose levels will be individually optimized

ABT-SLV187

Eligibility Criteria

• Age: 30 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• The subject must be willing to continue on treatment.

You may not qualify if:

• Subject is enrolled in another clinical trial.
• 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.
• 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.
• Uncooperative attitude or reasonable likelihood for non-compliance with the protocol.
• 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.
• Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-SLV187.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (7)

National Hospital Organization Asahikawa Medical Center /ID# 101178

Asahikawa, Hokkaido, 070-8644, Japan

Location

National Hospital Organization Sagamihara National Hospital /ID# 98662

Sagamihara-shi, Kanagawa, 252-0315, Japan

Location

Osaka University Hospital /ID# 108335

Suita-shi, Osaka, 565-0871, Japan

Location

National Center of Neurology and Psychiatry /ID# 98664

Kodaira, Tokyo, 187-8551, Japan

Location

Kyoto University Hospital /ID# 112136

Sakyo-ku, 606-8507, Japan

Location

Seoul National University Hospital /ID# 105935

Seoul, 03080, South Korea

Location

Linkou Chang Gung Memorial Ho /ID# 102297

Taoyuan, 33305, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 29511383 DERIVED

Related Links

• clinical study report synopsis

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: March 10, 2014
• Study Start: March 10, 2014
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• 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

JP (5); KR (1); TW (1)