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AzTrials

Parkinson DiseasePhase 1NCT02649608

An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients

A Phase 1 study testing 0.04 mg Lu AE04621, 0.08 mg Lu AE04621 and 0.2 mg Lu AE04621 in people with Parkinson Disease, run by H. Lundbeck A/S at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Parkinson Disease
What is being tested?
0.04 mg Lu AE04621, 0.08 mg Lu AE04621 and 0.2 mg Lu AE04621
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
4 sitesUnited States
Study dates
Jan 2016to Dec 2016
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is diagnosed with idiopathic Parkinson Disease (consistent with the UK Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of PD).
  • 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.

Who cannot join

  • The patient has cognitive impairment, defined as a Mini Mental State Examination(MMSE) score ≤ 26 at the Screening Visit.
  • 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))
  • Other protocol defined inclusion and exclusion criteria may apply

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • US1352

    Chicago, Illinois

  • US1084

    Detroit, Michigan

  • US1251

    Hallandale, Florida

  • US1126

    Orlando, Florida

Other trials in United States

About this study

Official title: Interventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's Disease

To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.

Read the detailed description

The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients with Parkinson's disease (men and/or women). Each patient will be treated for 3 or 4 days, with increasing dose each day.

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.

Being tested
0.04 mg Lu AE04621, 0.08 mg Lu AE04621, 0.2 mg Lu AE04621, 0.4 mg Lu AE04621, 0.6 mg Lu AE04621
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.04 mg Lu AE04621Drug

    0.04 mg dose group

  • 0.08 mg Lu AE04621Drug

    0.08mg dose group

  • 0.2 mg Lu AE04621Drug

    0.2 mg dose group

  • 0.4 mg Lu AE04621Drug

    0.4 mg dose group

  • 0.6 mg Lu AE04621Drug

    0.6 mg dose group

  • 0.8 mg Lu AE04621Drug

    0.8 mg dose group

  • 1.0 mg Lu AE04621Drug

    1.0 mg dose group

  • 1.2 mg Lu AE04621Drug

    1.2 mg dose group

Study groups in NCT02649608
Study groupRoleWhat they receive
0.04 mg Lu AE04621ExperimentalPatients having received a dose of 0.04 mg, independent of which Cohort they belong to.
Receives: Drug: 0.04 mg Lu AE04621
0.08 mg Lu AE04621ExperimentalPatients having received a dose of 0.08 mg, independent of which Cohort they belong to.
Receives: Drug: 0.08 mg Lu AE04621
0.2 mg Lu AE04621ExperimentalPatients having received a dose of 0.2 mg, independent of which Cohort they belong to.
Receives: Drug: 0.2 mg Lu AE04621
0.4 mg Lu AE04621ExperimentalPatients having received a dose of 1.2 mg, independent of which Cohort they belong to.
Receives: Drug: 0.4 mg Lu AE04621
0.6 mg Lu AE04621ExperimentalPatients having received a dose of 0.6 mg, independent of which Cohort they belong to.
Receives: Drug: 0.6 mg Lu AE04621
0.8 mg Lu AE04621ExperimentalPatients having received a dose of 0.8 mg, independent of which Cohort they belong to.
Receives: Drug: 0.8 mg Lu AE04621
1.0 mg Lu AE04621ExperimentalPatients having received a dose of 1.0 mg, independent of which Cohort they belong to.
Receives: Drug: 1.0 mg Lu AE04621
1.2 mg Lu AE04621ExperimentalPatients having received a dose of 1.2 mg, independent of which Cohort they belong to.
Receives: Drug: 1.2 mg Lu AE04621

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG)

    Number of patients with an adverse event

    Measured: Baseline to day 11

  2. Area Under the Plasma Concentration-time Curve (AUC(0-24 Hours)) for Lu AE04621

    Measured: From dosing to up to 24 hours after dosing

  3. Maximum Observed Concentration (Cmax) for Lu AE04621

    Measured: From dosing to up to 24 hours after dosing

  4. Apparent Elimination Half-life of Lu AE04621 in Plasma (t½)

    Measured: From dosing to up to 24 hours after dosing

  5. Time to Onset of "ON" Time After Lu AE04621 Administration

    "ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia.

    Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'.

    Measured: From dosing to 90 minutes after dosing

  6. Duration of "ON" Time

    "ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Outcome measured in minutes.

    Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON' following administration of Lu AE04621.

    Measured: From dosing up to 24h post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients (men and/or women). The dosing regimen planned for Cohort 1 was a dose of 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, and a dose of 0.6 mg Lu AE04621 on Day 3. • The dosing regimen planned for Cohort 2 was 0.4 mg Lu AE04621 on Day 1 followed by a dose of 0.6 mg Lu AE04621 on Day 2, and a dose of 0.8 mg Lu AE04621 on Day 3. The dosing regimen planned for Cohort 3 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.0 mg Lu AE04621 on Day 4. The dosing regimen planned for Cohorts 4 and 5 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.2 mg Lu AE04621 on Day 4. The results are presented by dose groups and are based on the actual doses administered.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02649608
Sponsor's protocol ID
16779A
Status last verified
Nov 2019
First submitted
6 Jan 2016
Last updated
24 Feb 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 0.04 mg Lu AE04621, 0.08 mg Lu AE04621 and 0.2 mg Lu AE04621 in people with Parkinson Disease, run by H. Lundbeck A/S at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG) (time frame: Baseline to day 11). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02649608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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