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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

Primary Purpose

Advanced Parkinson's Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ABT-SLV187

About this trial

This is an interventional treatment trial for Advanced Parkinson's Disease focused on measuring Safety, Tolerability, Efficacy, levodopa-carbidopa intestinal gel, levodopa, carbidopa, Advanced Parkinson's Disease

Eligibility Criteria

30 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

National Hospital Organization Asahikawa Medical Center /ID# 101178
National Hospital Organization Sagamihara National Hospital /ID# 98662
Osaka University Hospital /ID# 108335
National Center of Neurology and Psychiatry /ID# 98664
Kyoto University Hospital /ID# 112136
Seoul National University Hospital /ID# 105935
Linkou Chang Gung Memorial Ho /ID# 102297

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABT-SLV187

Arm Description

up to 6 years

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events

All negative changes in health during the study will be treated and recorded during the study.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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."

Full Information

NCT ID

NCT02082249

First Posted

February 14, 2014

Last Updated

May 11, 2021

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02082249

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

March 10, 2014 (Actual)

Primary Completion Date

October 31, 2019 (Actual)

Study Completion Date

October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Parkinson's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABT-SLV187

Arm Type

Experimental

Arm Description

up to 6 years

Intervention Type

Drug

Intervention Name(s)

ABT-SLV187

Intervention Description

Dose levels will be individually optimized

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Description

All negative changes in health during the study will be treated and recorded during the study.

Time Frame

From Day 1 up to 6 years (estimated maximum)

Secondary Outcome Measure Information:

Title

Change in Patient Global Impression of Change (PGIC) scores

Description

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.

Time Frame

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

Title

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

Description

The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the course of Parkinson's disease.

Time Frame

From Day 1 up to 36 months (estimated maximum)

Title

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

Description

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.

Time Frame

From Screening Visit 2 of M12-921 to Week 52

Title

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

Description

The study will assess the difference in the amount of time a subject is able to move and function well during the day.

Time Frame

From Day 1 to Week 52

Title

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

Description

The study will assess the difference in the amount of time a subject is unable to move and function during the day.

Time Frame

From Day 1 to Week 52

Title

Change in Clinical Global Impression of Change (CGI-C) scores

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

National Hospital Organization Asahikawa Medical Center /ID# 101178

City

Asahikawa

State/Province

Hokkaido

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

National Hospital Organization Sagamihara National Hospital /ID# 98662

City

Sagamihara-shi

State/Province

Kanagawa

ZIP/Postal Code

252-0315

Country

Japan

Facility Name

Osaka University Hospital /ID# 108335

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

National Center of Neurology and Psychiatry /ID# 98664

City

Kodaira

State/Province

Tokyo

ZIP/Postal Code

187-8551

Country

Japan

Facility Name

Kyoto University Hospital /ID# 112136

City

Sakyo-ku

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Seoul National University Hospital /ID# 105935

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Linkou Chang Gung Memorial Ho /ID# 102297

City

Taoyuan City

ZIP/Postal Code

33305

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

29511383

Citation

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.

Results Reference

derived

Links:

URL

https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/levodopa_carbidopa_M12-923.pdf

Description

clinical study report synopsis

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