Overview

This trial is active, not recruiting.

Condition advanced parkinson's disease
Treatment abt-slv187
Phase phase 3
Sponsor AbbVie
Start date March 2014
End date February 2017
Trial size 37 participants
Trial identifier NCT02082249, M12-923

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
52 Week Period
abt-slv187
Dose levels will be individually optimized

Primary Outcomes

Measure
Change in Vital Signs
time frame: From Day 1 up to 36 months (estimated maximum)
Change in Clinical Labs
time frame: Day 1 up to 36 months (estimated maximum)
Change in 12-lead electrocardiogram (ECG)
time frame: From Day 1 up to 36 months (estimated maximum)
Number of Participants with Adverse Events
time frame: From Day 1 up to 36 months (estimated maximum)

Secondary Outcomes

Measure
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 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 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 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 Unified Parkinson's Disease Rating Scale (UPDRS) score
time frame: From Day 1 up to 36 months (estimated maximum)
Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores
time frame: From Screening Visit 2 of M12-921 to Week 52

Eligibility Criteria

Male or female participants from 30 years up to 99 years old.

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. 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 study subjects. 6. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-SLV187.

Additional Information

Official title An Open-Label Two-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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.