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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 May 2021
• Main ID: NCT02082249
• Date of registration: 14/02/2014
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public 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
• Scientific 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
• Date of first enrolment: March 10, 2014
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02082249
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan, Korea, Republic of, Taiwan

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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.



Age minimum: 30 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Parkinson's Disease

Intervention(s)

Drug: ABT-SLV187

Primary Outcome(s)

Number of Participants with Adverse Events [Time Frame: From Day 1 up to 6 years (estimated maximum)]

Secondary Outcome(s)

Change in Patient Global Impression of Change (PGIC) scores [Time Frame: From Screening Visit 2 of M12-921 to Week 52 of M12-923]

Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores [Time Frame: From Screening Visit 2 of M12-921 to Week 52]

Change in Clinical Global Impression of Change (CGI-C) scores [Time Frame: From Screening Visit 2 of M12-921 to Week 52 of M12-923]

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 [Time Frame: From Day 1 to Week 52]

Change in the mean daily "Off" time (hours) as measured by the Parkinson's Disease (PD) Diary © [Time Frame: From Day 1 to Week 52]

Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score [Time Frame: From Day 1 up to 36 months (estimated maximum)]

Secondary ID(s)

M12-923

Source(s) of Monetary Support

Please refer to primary and secondary sponsors