Clinical Trials List
Protocol NumberM12-921
NCT Number(ClinicalTrials.gov Identfier)NCT01960842
2013-07-01 - 2015-12-31
Phase III
Terminated3
ICD-10G20
Parkinson's disease
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 Medications
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Trial Applicant
AbbVie
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Sponsor
Abbvie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 林政輝 Digestive System Department
- Tu-Hsueh YEH Division of Neurology
- 宋皚峰 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yi-Ting Hsu Division of Neurology
- Yu-Wan Yang Division of Neurology
- Jen-Wei Chou Digestive System Department
- Hui-Chun Huang Division of Neurology
- 陳政國 Digestive System Department
- Ming-Kuei Lu Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 劉高郎 Division of Neurology
- CHUN-HWEI TAI Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Available Anti Parkinsonian Medications
Objectives
The primary objective of this study is to evaluate the efficacy of ABT-SLV187 (known as
Duodopa®
in countries where it is marketed) monotherapy over 12 weeks of treatment
using the Parkinson's Disease Diary to assess the "Off" time change from baseline in
subjects with advanced Parkinson's disease and persistent motor complications despite
optimized treatment with available anti-parkinsonian medications. The secondary
objective is to assess the safety and tolerability of ABT-SLV187 in this patient
population.
Test Drug
ABT-SLV187 (Duodopa)
Active Ingredient
Levodopa & Carbidopa monohydrate
Dosage Form
Gel
Dosage
Levodopa: 20 mg/mL; Carbidopa monohydrate: 5 mg/mL
Endpoints
Efficacy:
The primary efficacy variable will be the change from baseline to Week 12 in the mean daily "Off" time
(hours) as measured by the PD Diary.
Secondary efficacy variables will include the following:
Change from baseline in PD Diary mean daily "Off" time (hours) at additional time points.
Change from baseline in PD Diary mean daily "On" time without troublesome dyskinesia ("On"
time without dyskinesia or with non-troublesome dyskinesia) and "On" time with troublesome
dyskinesia.
Clinical Global Impression of Change (CGI-C) scores
Patient Global Impression of Change (PGI-C) scores.
Change from baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Parts I to IV
scores.
Change from baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) summary index
and domain scores.
Safety:
Safety and tolerability will be assessed using the following parameters:
Physical examination including weight
Neurological examination
Vital signs
Clinical laboratory assessments including biochemistry, hematology, urinalysis and special labs
to detect vitamin deficiencies
Resting 12-lead electrocardiogram (ECG)
Concomitant medication use
Adverse event monitoring including the development of sleep attacks, melanoma, or excessive
impulsive behavior (including gambling or hypersexuality)
Monitoring complications of the infusion device
Abnormal Involuntary Movement Scale (AIMS)
Columbia-Suicide Severity Rating Scale (C-SSRS)
The primary efficacy variable will be the change from baseline to Week 12 in the mean daily "Off" time
(hours) as measured by the PD Diary.
Secondary efficacy variables will include the following:
Change from baseline in PD Diary mean daily "Off" time (hours) at additional time points.
Change from baseline in PD Diary mean daily "On" time without troublesome dyskinesia ("On"
time without dyskinesia or with non-troublesome dyskinesia) and "On" time with troublesome
dyskinesia.
Clinical Global Impression of Change (CGI-C) scores
Patient Global Impression of Change (PGI-C) scores.
Change from baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Parts I to IV
scores.
Change from baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) summary index
and domain scores.
Safety:
Safety and tolerability will be assessed using the following parameters:
Physical examination including weight
Neurological examination
Vital signs
Clinical laboratory assessments including biochemistry, hematology, urinalysis and special labs
to detect vitamin deficiencies
Resting 12-lead electrocardiogram (ECG)
Concomitant medication use
Adverse event monitoring including the development of sleep attacks, melanoma, or excessive
impulsive behavior (including gambling or hypersexuality)
Monitoring complications of the infusion device
Abnormal Involuntary Movement Scale (AIMS)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Inclution Criteria
1. Diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society (UKPDS)
Brain Bank Criteria.
2. Subjects have 4 or 5 in modified H & Y classification of disease severity at "Off" state determined
by the UPDRS Part V at Screening Visit 1.
3. The subject's advanced PD must be levodopa-responsive as judged by the Investigator.
4. Subjects have had optimal treatment with available PD 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 (or subject's proxy/caregiver) must be able to keep a Parkinson's Disease Diary©
.
7. 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 1and 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).
8. Male or female subjects of at least 30 years of age.
9. Subject must be able to successfully convert to oral study drug, levodopa-carbidopa 100/10 mg or
100/25 mg tablets and stop all other oral PD medications prior to ABT-SLV187 initiation via N-J.
Brain Bank Criteria.
2. Subjects have 4 or 5 in modified H & Y classification of disease severity at "Off" state determined
by the UPDRS Part V at Screening Visit 1.
3. The subject's advanced PD must be levodopa-responsive as judged by the Investigator.
4. Subjects have had optimal treatment with available PD 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 (or subject's proxy/caregiver) must be able to keep a Parkinson's Disease Diary©
.
7. 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 1and 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).
8. Male or female subjects of at least 30 years of age.
9. Subject must be able to successfully convert to oral study drug, levodopa-carbidopa 100/10 mg or
100/25 mg tablets and stop all other oral PD medications prior to ABT-SLV187 initiation via N-J.
Exclusion Criteria
1. PD 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 PD.
2. Subjects who have undergone neurosurgery for the treatment of PD.
3. Current primary psychiatric diagnosis of acute psychotic disorder or other uncontrolled primary
psychiatric diagnoses, (e.g., bipolar disorder or major depressive disorder per 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.
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.
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 PD.
2. Subjects who have undergone neurosurgery for the treatment of PD.
3. Current primary psychiatric diagnosis of acute psychotic disorder or other uncontrolled primary
psychiatric diagnoses, (e.g., bipolar disorder or major depressive disorder per 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.
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.
The Estimated Number of Participants
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Taiwan
5 participants
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Global
32 participants
