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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

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ClinicalTrials.gov Identifier: NCT02082249
Recruitment Status : Active, not recruiting
First Posted : March 10, 2014
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Advanced Parkinson's Disease Drug: ABT-SLV187 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2014
Estimated Primary Completion Date : December 27, 2023
Estimated Study Completion Date : December 27, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABT-SLV187
up to 9 years
Drug: ABT-SLV187
Dose levels will be individually optimized




Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: From Day 1 up to 9 years (estimated maximum) ]
    All negative changes in health during the study will be treated and recorded during the study.


Secondary Outcome Measures :
  1. Change in Patient Global Impression of Change (PGIC) scores [ Time Frame: 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.

  2. Change in the Unified Parkinson's Disease Rating Scale (UPDRS) score [ Time Frame: 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.

  3. Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) scores [ Time Frame: 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.

  4. 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 [ Time Frame: 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.

  5. Change in the mean daily "Off" time (hours) as measured by the Parkinson's Disease (PD) Diary © [ Time Frame: 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.

  6. Change in Clinical Global Impression of Change (CGI-C) scores [ Time Frame: 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."



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082249


Locations
Japan
National Hospital Organization Asahikawa Medical Center /ID# 101178
Asahikawa, Hokkaido, Japan, 070-8644
National Hospital Organization Sagamihara National Hospital /ID# 98662
Sagamihara-shi, Kanagawa, Japan, 252-0315
Osaka University Hospital /ID# 108335
Suita-shi, Osaka, Japan, 565-0871
National Center of Neurology and Psychiatry /ID# 98664
Kodaira, Tokyo, Japan, 187-8551
Kyoto University Hospital /ID# 112136
Sakyo-ku, Japan, 606-8507
Korea, Republic of
Seoul National University Hospital /ID# 105935
Seoul, Korea, Republic of, 03080
Taiwan
Linkou Chang Gung Memorial Ho /ID# 102297
Taoyuan City, Taiwan, 33305
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02082249     History of Changes
Other Study ID Numbers: M12-923
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Safety
Tolerability
Efficacy
levodopa-carbidopa intestinal gel
levodopa
carbidopa
Advanced Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors