Parkinson DiseasePhase 2ATTUNEDNCT03331848
Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)
A Phase 2 study testing PXT002331 - 20mg in people with Parkinson Disease, run by Prexton Therapeutics.
Trial summary
This is a Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing Motor Complications of Levodopa Therapy Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PXT002331 - 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2018to 1 Feb 2019
- Phase
- Phase 2
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 35 and 85 years of age, inclusive, at the time of signing informed consent
- Diagnosed after the age of 30 years with idiopathic PD
- A documented medical history of idiopathic PD for at least 3 years
- Disease severity of 2 to 4 on the modified Hoehn and Yahr scale when in the OFF state
- Been treated with a stable regimen of levodopa-containing therapy
- Subjects must be receiving at least 3 doses per day of levodopa-containing therapy, and must be on a stable dose for at least 2 weeks for immediate-release levodopa or at least 6 weeks for prolonged-release levodopa preparations prior to the first screening visit
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- Experienced LID over a period of at least 3 months prior to randomization
- If needed, in the opinion of the investigator, subjects must have a caregiver
- Female subjects will be women of non-childbearing potential
Who cannot join
- Patient is currently participating in or has participated in another study in the last 3 months
- Subjects with atypical, secondary, or drug-induced Parkinsonism
- Subjects with a history of dyskinesia that was exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic without peak-dose dyskinesia
- Subjects with a MoCA score of <25
- Subjects who have, or who had a history of, any clinically significant hepatic or gallbladder disorder, as determined by the investigator
- Subjects who have dementia, currently active psychosis, or hallucinations.
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- Suicide attempt within 1 year prior to the first screening visit, or severe suicidal ideation within 6 months prior to the first screening visit
- Subject has a current diagnosis of epilepsy,
- Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma
- Carcinoma or successfully treated squamous cell carcinoma of the skin and no sing of disease recurrence for at least 5 years
- Subjects who have had a clinically significant illness within 4 weeks before the first dose, as determined by the investigator
- Subjects with scheduled surgeries/hospitalizations during the study period
- Any advanced, severe, or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations
- Subjects who have undergone prior neurosurgical operation for PD,
- Subjects currently taking (or expected to be administered during the course of the study) any of the prohibited medications (amantadine, safinamide, dopamine-antagonists).
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)
This is a Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing Motor Complications of Levodopa Therapy
- Conditions
- Parkinson Disease
- Being tested
- Placebo oral capsule, PXT002331 - 20mg
- Keywords
- Levodopa-Induced Dyskinesia (LID), Foliglurax, Parkinson's Disease, mGlu4 PAM
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral capsuleDrug
BID
PXT002331 - 20mgDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| PXT002331 - 20mg | Experimental | Not described Receives: Drug: PXT002331 - 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia.
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start15 Jan 2018 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Why it stopped: Business reasons
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prexton Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331848
- Sponsor's protocol ID
- PXT-CL17-003
- Acronym
- ATTUNED
- Status last verified
- Oct 2017
- First submitted
- 1 Nov 2017
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)
- ClinicalTrials.gov ID
- NCT03331848
- Acronym / sponsor ID
- ATTUNED / PXT-CL17-003
- Conditions
- Parkinson Disease
- Keywords
- Levodopa-Induced Dyskinesia (LID), Foliglurax, Parkinson's Disease, mGlu4 PAM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Prexton TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 6 Nov 2017 (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.
This is a Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing Motor Complications of Levodopa Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Drug: Placebo oral capsule |
| PXT002331 - 20mg | Experimental | Drug: PXT002331 - 20mg |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between 35 and 85 years of age, inclusive, at the time of signing informed consent
- Diagnosed after the age of 30 years with idiopathic PD
- A documented medical history of idiopathic PD for at least 3 years
- Disease severity of 2 to 4 on the modified Hoehn and Yahr scale when in the OFF state
- Been treated with a stable regimen of levodopa-containing therapy
Key exclusion criteria (15 listed)
- Patient is currently participating in or has participated in another study in the last 3 months
- Subjects with atypical, secondary, or drug-induced Parkinsonism
- Subjects with a history of dyskinesia that was exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic without peak-dose dyskinesia
- Subjects with a MoCA score of <25
- Subjects who have, or who had a history of, any clinically significant hepatic or gallbladder disorder, as determined by the investigator
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 |
|---|---|---|
| Placebo oral capsuleBID | Drug | PLACEBO |
| PXT002331 - 20mgOral | Drug | PXT002331 - 20mg |
Primary outcome
Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia.
Time frame: 26 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PXT002331 - 20mg in people with Parkinson Disease, run by Prexton Therapeutics.
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 9 inclusion and 15 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: withdrawn, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia. (time frame: 26 days). 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 22 Mar 2018.