Clinical Trials List
Protocol NumberM12-923
2013-10-01 - 2017-12-31
Phase III
Terminated2
Study ended1
ICD-10G21.9
Secondary parkinsonism, unspecified
ICD-10G21.8
Other secondary parkinsonism
ICD-9332.1
Secondary Parkinsonism
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 Applicant
AbbVie
-
Sponsor
Abbvie
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Tu-Hsueh YEH Division of Neurology
- 宋皚峰 Digestive System Department
- 林政輝 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- CHUN-HWEI TAI Division of Neurology
- 劉高郎 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hui-Chun Huang Division of Neurology
- 陳政國 Digestive System Department
- Ming-Kuei Lu Division of Neurology
- Yu-Wan Yang Division of Neurology
- Jen-Wei Chou Digestive System Department
- Yi-Ting Hsu Division of Neurology
The Actual Total Number of Participants Enrolled
2 Study ended
Condition/Disease
Available Anti-Parkinsonian Medications
Objectives
The primary objective of this extension study is to evaluate the long-term safety and
tolerability of ABT-SLV187 (known as Duodopa®
in countries where it is marketed) in
subjects with advanced PD and persistent motor complications despite optimized
treatment with available anti-Parkinson's disease medications.
The secondary objective is to assess the long-term maintenance of efficacy of
ABT-SLV187 in these subjects over a period of 12 months.
Test Drug
ABT-SLV187 (Duodopa)
Active Ingredient
Levodopa & Carbidopa monohydrate
Dosage Form
Gel
Dosage
Levodopa: 20 mg/mL; Carbidopa monohydrate: 5 mg/mL
Endpoints
Safety:
treatment-emergent adverse events
clinical labs
vital signs
ECGs
product quality complaints
abnormal findings on neurological exams
impulsivity as reported on the MIDI
sleep attacks as reported in the sleep attack interview
potential tardive dyskinesia based on the AIMS
suicidal ideation or behavior reported on the C-SSRS
Tolerability will be assessed by the number of subjects who complete the study.
Efficacy:
PD Diary variables will include average daily normalized "Off" time, "On" time with troublesome
dyskinesia and "On" time without troublesome dyskinesia.
Efficacy analyses will also be performed for the following additional variables.
UPDRS total score, Parts I to IV scores and dyskinesia item score
PDQ-39 summary index and domain scores
PGI-C score and responder category
CGI-C score
treatment-emergent adverse events
clinical labs
vital signs
ECGs
product quality complaints
abnormal findings on neurological exams
impulsivity as reported on the MIDI
sleep attacks as reported in the sleep attack interview
potential tardive dyskinesia based on the AIMS
suicidal ideation or behavior reported on the C-SSRS
Tolerability will be assessed by the number of subjects who complete the study.
Efficacy:
PD Diary variables will include average daily normalized "Off" time, "On" time with troublesome
dyskinesia and "On" time without troublesome dyskinesia.
Efficacy analyses will also be performed for the following additional variables.
UPDRS total score, Parts I to IV scores and dyskinesia item score
PDQ-39 summary index and domain scores
PGI-C score and responder category
CGI-C score
Inclution Criteria
1. Subjects completing 12 weeks treatment in Study M12-921 or 21 days treatment in Study M12-925,
who, in the opinion of the Investigator, would benefit from long-term treatment from ABT-SLV187.
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.
4. Female subjects of childbearing potential practicing at least one of the following methods of birth
control throughout the study:
Total abstinence from intercourse;
Vasectomized partner(s);
Intrauterine device (IUD);
Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with
spermicidal foam/gel/film/cream/suppository). Diaphragm must be used with spermicidal foam
or jelly. The combination of diaphragm and spermicidal substance counts as a single barrier;
Using oral, injected, or implanted methods of hormonal contraceptives (oral, parenteral or
transdermal) for at least 3 months prior to study drug administration and the partner should also
use a barrier method (e.g., condom) with spermicidal foam/gel/film/cream/suppository during
this study and for 90 days after study drug completion;
All female subjects of childbearing potential must have negative result of a serum pregnancy
test performed at Screening and a negative urine pregnancy test result is required prior to any
radiological procedures and prior to any PEG-J placement procedures;
If male, must be surgically sterile (vasectomy), agree to be sexually inactive or use a barrier method
(condom) of birth control from the time of the Initial Screening Visit through 30 days after the
administration study drug ends.
who, in the opinion of the Investigator, would benefit from long-term treatment from ABT-SLV187.
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.
4. Female subjects of childbearing potential practicing at least one of the following methods of birth
control throughout the study:
Total abstinence from intercourse;
Vasectomized partner(s);
Intrauterine device (IUD);
Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with
spermicidal foam/gel/film/cream/suppository). Diaphragm must be used with spermicidal foam
or jelly. The combination of diaphragm and spermicidal substance counts as a single barrier;
Using oral, injected, or implanted methods of hormonal contraceptives (oral, parenteral or
transdermal) for at least 3 months prior to study drug administration and the partner should also
use a barrier method (e.g., condom) with spermicidal foam/gel/film/cream/suppository during
this study and for 90 days after study drug completion;
All female subjects of childbearing potential must have negative result of a serum pregnancy
test performed at Screening and a negative urine pregnancy test result is required prior to any
radiological procedures and prior to any PEG-J placement procedures;
If male, must be surgically sterile (vasectomy), agree to be sexually inactive or use a barrier method
(condom) of birth control from the time of the Initial Screening Visit through 30 days after the
administration study drug ends.
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 (C-SSRS) 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.
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 (C-SSRS) 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.
The Estimated Number of Participants
-
Taiwan
5 participants
-
Global
37 participants
