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

Advanced Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082249
• Other study ID #: M12-923
• Status: Completed
• Phase: Phase 3
• Start date: March 10, 2014
• Est. completion date: October 31, 2019

Study information

• Verified date: May 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• ABT-SLV187
Dose levels will be individually optimized

Locations

Country	Name	City	State
Japan	National Hospital Organization Asahikawa Medical Center /ID# 101178	Asahikawa	Hokkaido
Japan	National Center of Neurology and Psychiatry /ID# 98664	Kodaira	Tokyo
Japan	National Hospital Organization Sagamihara National Hospital /ID# 98662	Sagamihara-shi	Kanagawa
Japan	Kyoto University Hospital /ID# 112136	Sakyo-ku
Japan	Osaka University Hospital /ID# 108335	Suita-shi	Osaka
Korea, Republic of	Seoul National University Hospital /ID# 105935	Seoul
Taiwan	Linkou Chang Gung Memorial Ho /ID# 102297	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis