Clinical trial NCT02082249: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Parkinson's Disease
Keywords: Safety
Tolerability
Efficacy
levodopa-carbidopa intestinal gel
levodopa
carbidopa
Advanced Parkinson's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: From Day 1 up to 6 years (estimated maximum)
Secondary outcomes:
measure: Change in Patient Global Impression of Change (PGIC) scores
timeFrame: From Screening Visit 2 of M12-921 to Week 52 of M12-923
measure: Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score
timeFrame: From Day 1 up to 36 months (estimated maximum)
measure: Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores
timeFrame: From Screening Visit 2 of M12-921 to Week 52
measure: 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
timeFrame: From Day 1 to Week 52
measure: Change in the mean daily "Off" time (hours) as measured by the Parkinson's Disease (PD) Diary ©
timeFrame: From Day 1 to Week 52
measure: Change in Clinical Global Impression of Change (CGI-C) scores
timeFrame: From Screening Visit 2 of M12-921 to Week 52 of M12-923
Other outcomes:
Locations:
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center /ID# 101178
state: Hokkaido
city: Sagamihara-shi
country: Japan
facility: National Hospital Organization Sagamihara National Hospital /ID# 98662
state: Kanagawa
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 108335
state: Osaka
city: Kodaira
country: Japan
facility: National Center of Neurology and Psychiatry /ID# 98664
state: Tokyo
city: Sakyo-ku
country: Japan
facility: Kyoto University Hospital /ID# 112136
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 105935
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Ho /ID# 102297
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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.