A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01960842
• Date of registration: 09/10/2013
• Prospective Registration: No
• Primary sponsor: AbbVie
• Public title: A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications
• Scientific title: An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medication
• Date of first enrolment: October 2013
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01960842
• 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: Masayoshi Yanagawa, PhD
• Affiliation: AbbVie Japan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease according to the United Kingdom
Parkinson's Disease Society (UKPDS) Brain Bank Criteria.

2. Subjects have 4 or 5 in modified Hohn and Yahr (H & Y) classification of disease
severity at "Off" state determined by the UPDRS Part V at Screening Visit 1.

3. The subject's advanced Parkinson's disease must be levodopa-responsive as judged by
the Investigator.

4. Subjects have had optimal treatment with available Parkinson's disease medication as
defined by local standards of care and, based upon the judgment of the Investigator,
and their symptoms are judged inadequately controlled on this optimized treatment.
Optimized treatment is defined as the maximum therapeutic effect obtained with
available anti-parkinsonian pharmacological therapy when no further improvement is
expected regardless of any additional manipulations of levodopa and/or other anti
parkinsonian medication; this will be based on the Investigator's best clinical
judgment.

5. Presence of a recognizable "Off" and "On" state (motor fluctuations) as confirmed by
UPDRS Part III (in both "On" and "Off" states), and by the Parkinson's Disease Diary©
which must be observed and confirmed at Screening Visit 1.

6. Subjects must be experiencing a minimum of 3 hours per day of "Off" time, as estimated
by the Investigator and supported by the UPDRS at Screening Visit 1 and the
Parkinson's Disease Diaries at baseline. The "Off" time must occur during a continuous
16-hour interval, including the portion of the day during which the subject is awake
the majority of the time (e.g., 5 AM to 9 PM, 7 AM to 11 PM).

Exclusion Criteria:

1. Parkinson's disease diagnosis is unclear or a suspicion of other parkinsonian
syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious
agents, vascular disease, trauma, brain neoplasm), Parkinson's-plus syndromes (e.g.,
multiple system atrophy, progressive supranuclear palsy) or the other
neurodegenerative diseases that might mimic the symptoms of Parkinson's disease .

2. Subjects who have undergone neurosurgery for the treatment of Parkinson's disease .

3. Current primary psychiatric diagnosis of acute psychotic disorder or other
uncontrolled primary psychiatric diagnoses, (e.g., bipolar disorder or major
depressive disorder per Diagnostic and Statistical Manual of Mental Disorders 4th
edition, Text Revision (DSM-IV-TR) criteria.

4. Alzheimer's disease; or other significant cognitive impairment or dementia (defined as
Mini-Mental State Examination (MMSE) total score < 24).

5. Subject has significant current suicidal ideation within the previous year as
evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of
the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening or any
history of suicide attempts.

6. A low B12 level or low-normal B12 level (less than 300 pg/mL) with elevated
methylmalonic acid (MMA). Note: Abnormal Vitamin B12 of questionable clinical
significance (i.e., indeterminate or low normal results) prior to or at Screening
Visit 2 require appropriate interpretation in conjunction with MMA and homocysteine
laboratory values prior to proceeding further into the study.



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Parkinson's Disease

Intervention(s)

Device: PEG tube

Device: J-tube

Device: CADD-Legacy® 1400 ambulatory infusion pump

Drug: Levodopa-carbidopa intestinal gel

Primary Outcome(s)

Average Daily Normalized "Off" Time: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Secondary Outcome(s)

Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Number of Participants With Potentially Clinically Significant Values for Hematology Parameters [Time Frame: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)]

Average Daily Normalized "Off" Time Excluding Subjects Who Did Not Receive LCIG During the Entire PEG-J Period: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Average Daily Normalized "Off" Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Weeks 2, 4, 6, 8, 10, and 12]

Average Daily Normalized "Off" Time Including All PD Diaries Regardless if They Were Completed After the Subject Had Used a Concomitant Anti-Parkinsonian Medication: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl Score: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Clinical Global Impression - Change (CGI-I) Score at the Final PEG-J Visit [Time Frame: Final PEG-J Visit (up to week 12)]

Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters [Time Frame: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)]

Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG) [Time Frame: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)]

Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline (end of screening period) and Final PEG-J Visit (up to week 12)]

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Time Frame: From N-J placement to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days.]

Patient Global Impression of Change (PGI-C) Score at the Final PEG-J Visit [Time Frame: Final PEG-J Visit (up to week 12)]

Unified Parkinson's Disease Rating Scale (UPDRS) Total Score: Change From Baseline To The Final PEG-J Visit [Time Frame: Baseline and Final PEG-J Visit (up to Week 12)]

Number of Participants With Potentially Clinically Significant Vital Sign Parameters [Time Frame: From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)]

Secondary ID(s)

M12-921

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/04/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01960842