Lu AF28996 in Participants With Parkinson's Disease (PD)

• Register: ClinicalTrials.gov
• Last refreshed on: 24 February 2025
• Main ID: NCT04291859
• Date of registration: 28/02/2020
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: Lu AF28996 in Participants With Parkinson's Disease (PD)
• Scientific title: Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's Disease
• Date of first enrolment: February 26, 2020
• Target sample size: 63
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04291859
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France, Germany, Netherlands, Spain, United States

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

• Name: Email contact via H. Lundbeck A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants diagnosed with idiopathic PD (consistent with the UK PD Society Brain
Bank Criteria for the Diagnosis of PD), with not more than 1 first-degree relative
who has PD.

- Participants must have a Modified Hoehn and Yahr score =4 in the OFF state and =3 in
the ON state, and a Mini Mental State Examination score >25.

- The OFF/ON amplitude on the MDS-UPDRS Part III at screening must be minimum 30%
difference.

- Participants must experience recognizable and predictable motor fluctuations (with
at least 1.5 hours of OFF periods in the awake time, including predictable morning
OFF episodes), causing clinically significant disability during the 7-week Screening
Period, as evaluated by the investigator. This will be documented using a
participant ON/OFF state registration over 3 consecutive days prior to enrolment.

- Allowed concomitant medication for PD during the study includes levodopa, monoamine
oxidase B inhibitors, COMT inhibitors, anticholinergics, and amantadine. Dopamine
agonists are not allowed and should be discontinued =4 weeks prior to dosing with Lu
AF28996 and until the end of the study.

- Participants diagnosed with idiopathic PD (consistent with the UK PD Society Brain
Bank Criteria for the Diagnosis of PD), with not more than 1 first-degree relative
who has PD.

- Participants must have a Modified Hoehn and Yahr score =2 to =4 in the OFF state and
=3 in the ON state, a MDS-UPDRS Part IV, 4.5 score of 1 or 2, and a MDS-UPDRS Part
IV, 4.2 score =2 (at least mild functional impact), and a Mini Mental State
Examination score >25 at the Screening Visit.

- Participants must currently have a good response to levodopa and be receiving a
stable dose of levodopa (=3 doses per day of levodopa/dopa decarboxylase inhibitor
therapy or =3 doses per day of levodopa Extended-Release Capsules and LEDD between
400 and 1600, inclusive) for at least 4 weeks prior to screening.

- Participants must experience recognizable and predictable motor fluctuations (with
=3 hours of OFF periods in the awake time, including predictable morning OFF
episodes), causing clinically significant disability during 3 months prior to
enrolment, as evaluated by the investigator. The criteria will be documented using
Hauser Diary over 3 consecutive days prior to enrolment.

- Participants must experience =1 hour daily ON time with troublesome dyskinesia (TD)
in the awake time (TD/24 hours while awake) during the last 3 months prior to
enrolment as evaluated by the investigator. The criteria will be documented using
the Hauser Diary over 3 consecutive days prior to enrolment.

- Allowed concomitant medication for PD during the study includes levodopa, dopamine
agonists, if allowed daily dose, monoamine oxidase B inhibitors, COMT inhibitors,
anticholinergics, and amantadine.

Exclusion Criteria:

- The participant has or had one or more of the following conditions that are
considered clinically relevant in the context of the study; other neurological
disorder, psychiatric disorder, seizure disorder or encephalopathy, respiratory
disease, hepatic impairment or renal insufficiency, metabolic disorder,
endocrinological disorder, haematological disorder, infectious disorder, any
clinically significant immunological condition, or a history of narrow-angle
glaucoma.

- Participant has been treated with apomorphine (pen/pump), and/or inhaled levodopa
and/or levodopa/carbidopa intestinal gel (LCIG),and/or subcutaneous
foslevodopa/foscarbidopa within 6 weeks prior to the Baseline Visit.

- Participants formerly treated with oral or transdermal dopamine agonists must have
discontinued 4 weeks prior to screening.

- Participant has a history of Dopamine Agonist Withdrawal Syndrome (DAWS) when
dopamine agonists were previously discontinued or reduced.

Other inclusion and exclusion criteria may apply.


Age minimum: 35 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Lu AF28996

Primary Outcome(s)

Number of Participants with Treatment-emergent Adverse Events [Time Frame: From Baseline to 5.5 Months]

Cmax of Lu AF28996 [Time Frame: 0 (predose) to 24 hours postdose on Day 1 to Day 47]

Tmax of Lu AF28996 [Time Frame: 0 (predose) to 24 hours postdose on Day 1 to Day 47]

Secondary ID(s)

18252A

2019-001280-77

Source(s) of Monetary Support

Please refer to primary and secondary sponsors