Parkinson DiseasePhase 1NCT04322227
Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects
A Phase 1 study testing Foliglurax 10 mg (treatment A) and Foliglurax 30 mg (treatment B) in people with Parkinson Disease and Healthy, run by H. Lundbeck A/S at 1 site in France.
Trial summary
The purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with PD Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Healthy
- What is being tested?
- Foliglurax 10 mg (treatment A) and Foliglurax 30 mg (treatment B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2020to 30 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- The subject has an acceptable resting EEG at the Screening Visit, as judged by the investigator
- The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
- Patients with PD
- The patient has an acceptable resting EEG performed at the screening period, as judged by the investigator.
- The patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
- The patient has been diagnosed with idiopathic PD for ≥3 years, with a current disease severity of 2 to 4 on the modified Hoehn and Yahr scale in the 'off' state.
- The patient has dyskinesia that is not too severe to cause discomfort for the patient during the EEG assessments
Who cannot join
- The subject has taken disallowed medication <1 week prior to the first dose of Investigational Medicinal Product (IMP) or <5 half-lives prior to the Screening Visit for any medication taken.
- The subject has significant alcohol consumption
- The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP.
- The subjects has a known genetic disorder of human UDPglucoronosyltransferase
- The subject is pregnant or breastfeeding.
- Other in- and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy Subjects
The purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with PD
Read the detailed description
All Treatment Periods (P1 to P3) consist of 7 days of dosing (D1 to D7) with either:
- 10 mg foliglurax bis in die (BID) (treatment A)
- 30 mg foliglurax BID (treatment B)
- Placebo BID (treatment C)
- Conditions
- Parkinson Disease, Healthy
- Being tested
- Foliglurax 10 mg (treatment A), Foliglurax 30 mg (treatment B), Placebo (treatment C)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foliglurax 10 mg (treatment A)Drug
Foliglurax 10 mg, (BID) capsules, orally
Foliglurax 30 mg (treatment B)Drug
Foliglurax 30 mg, BID capsules, orally
Placebo (treatment C)Drug
Placebo, BID capsules, orally
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Not described Receives: Drug: Foliglurax 10 mg (treatment A); Drug: Foliglurax 30 mg (treatment B); Drug: Placebo (treatment C) |
| PD | Experimental | Not described Receives: Drug: Foliglurax 10 mg (treatment A); Drug: Foliglurax 30 mg (treatment B); Drug: Placebo (treatment C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency of EEG movement related desynchronization of the μ-oscillations
Latency of μ-desynchronization ipsilateral and contralateral (in ms)
Measured: From baseline to Day 7 in each Treatment Period
Latency of EEG movement related synchronization of the beta-oscillations
Latency of beta-rebound ipsilateral and contralateral (in ms)
Measured: From baseline to Day 7 in each Treatment Period
Offset of EEG movement related synchronization of the beta-oscillations
Offset of beta-rebound ipsilateral and contralateral (in ms)
Measured: From baseline to Day 7 in each Treatment Period
Latency of movement from cue measured by accelerometer
Latency of movement from cue (in ms)
Measured: From baseline to Day 7 in each Treatment Period
Average power in u-desynchronization cluster measured by EEG
Power in μ-desynchronization cluster ipsilateral and contralateral (in micro-volts squared)
Measured: From baseline to Day 7 in each Treatment Period
Average power in beta-rebound cluster measured by EEG
Power in beta-rebound cluster ipsilateral and contralateral (in micro-volts squared)
Measured: From baseline to Day 7 in each Treatment Period
Power in the frequency domain of the greater tremor frequency
Power in micro-volts squared
Measured: From baseline to Day 7 in each Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start23 Jan 2020
- Primary completion30 May 2020
- Study completion30 May 2020
Why it stopped: Study termination due to efficacy results of another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322227
- Sponsor's protocol ID
- 18240A
- Status last verified
- Jul 2020
- First submitted
- 29 Jan 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04322227
- Acronym / sponsor ID
- 18240A
- Conditions
- Parkinson Disease, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study termination due to efficacy results of another study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with PD
Detailed description
All Treatment Periods (P1 to P3) consist of 7 days of dosing (D1 to D7) with either:
- 10 mg foliglurax bis in die (BID) (treatment A)
- 30 mg foliglurax BID (treatment B)
- Placebo BID (treatment C)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Drug: Foliglurax 10 mg (treatment A), Drug: Foliglurax 30 mg (treatment B), Drug: Placebo (treatment C) |
| PD | Experimental | Drug: Foliglurax 10 mg (treatment A), Drug: Foliglurax 30 mg (treatment B), Drug: Placebo (treatment C) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy subjects
- The subject has an acceptable resting EEG at the Screening Visit, as judged by the investigator
- The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
- Patients with PD
- The patient has an acceptable resting EEG performed at the screening period, as judged by the investigator.
Key exclusion criteria (6 listed)
- The subject has taken disallowed medication <1 week prior to the first dose of Investigational Medicinal Product (IMP) or <5 half-lives prior to the Screening Visit for any medication taken.
- The subject has significant alcohol consumption
- The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP.
- The subjects has a known genetic disorder of human UDPglucoronosyltransferase
- The subject is pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foliglurax 10 mg (treatment A)Foliglurax 10 mg, (BID) capsules, orally | Drug | Healthy, PD |
| Foliglurax 30 mg (treatment B)Foliglurax 30 mg, BID capsules, orally | Drug | Healthy, PD |
| Placebo (treatment C)Placebo, BID capsules, orally | Drug | Healthy, PD |
Primary outcome
Latency of EEG movement related desynchronization of the μ-oscillations
Time frame: From baseline to Day 7 in each Treatment Period
Latency of μ-desynchronization ipsilateral and contralateral (in ms)
Latency of EEG movement related synchronization of the beta-oscillations
Time frame: From baseline to Day 7 in each Treatment Period
Latency of beta-rebound ipsilateral and contralateral (in ms)
Offset of EEG movement related synchronization of the beta-oscillations
Time frame: From baseline to Day 7 in each Treatment Period
Offset of beta-rebound ipsilateral and contralateral (in ms)
Latency of movement from cue measured by accelerometer
Time frame: From baseline to Day 7 in each Treatment Period
Latency of movement from cue (in ms)
Average power in u-desynchronization cluster measured by EEG
Time frame: From baseline to Day 7 in each Treatment Period
Power in μ-desynchronization cluster ipsilateral and contralateral (in micro-volts squared)
Average power in beta-rebound cluster measured by EEG
Time frame: From baseline to Day 7 in each Treatment Period
Power in beta-rebound cluster ipsilateral and contralateral (in micro-volts squared)
Power in the frequency domain of the greater tremor frequency
Time frame: From baseline to Day 7 in each Treatment Period
Power in micro-volts squared
Results and safety
The study was stopped early (reason given: Study termination due to efficacy results of another study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Foliglurax 10 mg (treatment A) and Foliglurax 30 mg (treatment B) in people with Parkinson Disease and Healthy, run by H. Lundbeck A/S at 1 site in France.
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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study was stopped early (reason given: Study termination due to efficacy results of another study). Results are not available in the source record.
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?
Latency of EEG movement related desynchronization of the μ-oscillations (time frame: From baseline to Day 7 in each Treatment Period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2020.