Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.

Phase 1

• Conditions: Parkinson's Disease; MedDRA version: 21.1Level: PTClassification code 10068100Term: Vascular parkinsonismSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-004235-23-IT
• Lead Sponsor: ABBVIE DEUTSCHLAND GMBH & CO. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Subject must be able to understand the nature of the study and have had the opportunity to have any questions answered by the investigator.
2. Subject, if judged by the investigator to have decision making capacity, must voluntarily sign and date an informed consent form approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to initiation of any study-specific procedures.
3. Subject completed ABBV-951 Study M15-741 (parent study).
4. Subject is willing and able to comply with procedures required in this protocol.
5. Subject is not considered by the investigator to be an unsuitable candidate to continue to receive ABBV-951 for any reason.
6. Subject confirms to not have suicidal ideation (as evidenced by answering no to Questions 4 or 5 on the suicidal ideation portion of the C-SSRS) at the Final Visit of the parent study.
7. If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least 1 protocol-specified method of birth control that is effective from D1 through at least 30 days after the end of the infusion of study drug. Subject is not pregnant, breastfeeding, or considering becoming pregnant or donating eggs during the study or within 30 days after the end of the infusion of study drug. If female of childbearing potential, subject must have a negative urine pregnancy test on D1.
8. If male and sexually active with a female partner(s) of childbearing potential, subject must agree to practice protocol-specified contraception. Subject is not considering fathering a child or donating sperm during the study or within 30 days after the end of the infusion of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1. Subject has received an investigational product other than ABBV-951 within a time period equal to 5 half-lives, if known, or within 6 weeks, whichever is longer, prior to study drug administration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified