Advanced Parkinson's Disease
Conditions
Keywords
Safety, Tolerability, Efficacy, levodopa-carbidopa intestinal gel, levodopa, carbidopa, Advanced Parkinson's Disease
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.
Interventions
DRUGABT-SLV187
Dose levels will be individually optimized
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | From Day 1 up to 6 years (estimated maximum) | All negative changes in health during the study will be treated and recorded during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score | From Day 1 up to 36 months (estimated maximum) | 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 | From Screening Visit 2 of M12-921 to Week 52 | 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 Patient Global Impression of Change (PGIC) scores | From Screening Visit 2 of M12-921 to Week 52 of M12-923 | 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 mean daily Off time (hours) as measured by the Parkinson's Disease (PD) Diary © | From Day 1 to Week 52 | 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 | From Screening Visit 2 of M12-921 to Week 52 of M12-923 | 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. |
| 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 | The study will assess the difference in the amount of time a subject is able to move and function well during the day. |
Countries
Japan, South Korea, Taiwan
Outcome results
None listed