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Completed

NCT Number: 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

This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.

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Key information

Age range

30 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Hospital Organization Asahikawa Medical Center /ID# 101178, Asahikawa, Hokkaido, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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).
  • The subject must be willing to continue on treatment.

Exclusion criteria

  • Subject is enrolled in another clinical trial.
  • 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.
  • 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.
  • Uncooperative attitude or reasonable likelihood for non-compliance with the protocol.
  • 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.
  • Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-SLV187.

Treatment and study plan

ABT-SLV187

Drug

Dose levels will be individually optimized

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: From Day 1 up to 6 years (estimated maximum)

    All negative changes in health during the study will be treated and recorded during the study.

Secondary outcomes

  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."

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2014
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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