An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
NCT ID: NCT02649608
Last Updated: 2021-02-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2016-01-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lu AF28996 in Participants With Parkinson's Disease (PD)
NCT04291859
A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.
NCT05924243
A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD)
NCT06004180
A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PD
NCT04630860
Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
NCT03611569
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Dosing regimen will be decided at a dosing conferences. Dose levels can be increased, maintained or reduced both between cohorts but also within same cohort. The results are presented by dose level and reflect the actual doses administered.
A follow-up safety visit was scheduled approximately 7 days after the last dose of IMP.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0.04 mg Lu AE04621
Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
0.04 mg Lu AE04621
0.04 mg dose group
0.08 mg Lu AE04621
Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
0.08 mg Lu AE04621
0.08mg dose group
0.2 mg Lu AE04621
Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
0.2 mg Lu AE04621
0.2 mg dose group
0.4 mg Lu AE04621
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
0.4 mg Lu AE04621
0.4 mg dose group
0.6 mg Lu AE04621
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
0.6 mg Lu AE04621
0.6 mg dose group
0.8 mg Lu AE04621
Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
0.8 mg Lu AE04621
0.8 mg dose group
1.0 mg Lu AE04621
Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
1.0 mg Lu AE04621
1.0 mg dose group
1.2 mg Lu AE04621
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
1.2 mg Lu AE04621
1.2 mg dose group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
0.04 mg Lu AE04621
0.04 mg dose group
0.08 mg Lu AE04621
0.08mg dose group
0.2 mg Lu AE04621
0.2 mg dose group
0.4 mg Lu AE04621
0.4 mg dose group
0.6 mg Lu AE04621
0.6 mg dose group
0.8 mg Lu AE04621
0.8 mg dose group
1.0 mg Lu AE04621
1.0 mg dose group
1.2 mg Lu AE04621
1.2 mg dose group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The patient's Hoehn and Yahr Staging score is ≤ 3 in the "ON" state.
* The patient experiences motor fluctuations with at least 2.5 hours of "OFF" periods in the awake time and has predictable morning "OFF" episodes, which have been consistent within the past 4 weeks.
* The patient currently has a good response to L-DOPA and has been receiving a stable dose of L-DOPA (≥3 doses per day of standard L-DOPA or ≥3 doses per day of Carbidopa and L-DOPA, Extended-Release Capsules) during at least four weeks prior to screening.
Exclusion Criteria
* The patient has severe disabling dyskinesia
* The patient takes or has taken disallowed recent or concomitant medication (CYP2D6 inhibitors, CYP 3A4 substrate, Dopamine agonists, 5 HT3 antagonists, Anti-viral (Amantadine))
45 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
H. Lundbeck A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
US1251
Hallandale, Florida, United States
US1126
Orlando, Florida, United States
US1352
Chicago, Illinois, United States
US1084
Detroit, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16779A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.