Parkinson DiseasePhase 2NCT04147949
AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
A Phase 2 study testing AV-101 in people with Parkinson Disease and Dyskinesia, Medication-Induced, run by VistaGen Therapeutics, Inc..
Trial summary
This is a randomized, double-blind, placebo-controlled, crossover, proof-of-concept Phase 2 study to test efficacy and safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease subjects with levodopa-induced dyskinesia. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease, Dyskinesia, Medication-Induced, L-Dopa Causing Adverse Effects in Therapeutic Use
- What is being tested?
- AV-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Apr 2024
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults, 30 to 80 years of age, inclusive.
- Diagnosis of idiopathic PD meeting the United Kingdom Parkinson's disease Society Brain Bank criteria.
- Levodopa-induced dyskinesia present greater than 25% of the day as per MDS-UPDRS.
- Dyskinesia of at least moderate severity as per MDS-UPDRS
- Subjects currently receiving anti-parkinsonian medications that contain levodopa and carbidopa are eligible provided they have been on a stable dose of these medications for at least 1 month prior to randomization.
- Subjects currently receiving antidepressants such as selective serotonin reuptake inhibitors, provided the dose has been stable for at least 1 month prior to randomization.
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- If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:
- Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is postmenopausal with her last menses at least 1 year prior to screening); or
- . Childbearing potential, and meets all of the following criteria: i. Women with a negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test at randomization prior to receiving study treatment.
- Women who are willing and able to continuously use one of the following methods of birth control during the course of the study, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly: implants, injectable or patch hormonal contraception, oral contraceptives, intrauterine device, sexual abstinence. The form of birth control will be documented at screening.
- Male partner must use a condom.
Who cannot join
- Women with childbearing potential who are not willing to use one of the specified forms of birth control during the study or whose partner is unwilling to use a condom.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test at screening or baseline.
- Currently taking a prohibited adjunct therapy such amantadine or monoamine oxidase (MAO) inhibitors must be discontinued at least 3 weeks prior to baseline.
- Subject had a prior surgery for PD except Deep Brain Stimulation (Deep Brain Stimulation must not have been performed within one year of screening)
- Hoehn and Yahr score of 5 when "off".
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- Subject with Cognitive impairment and/or history of psychiatric manifestations or active hallucinations.
- History of positive screening urine test for drugs of abuse at screening: cannabinoids (if the subject has a legitimate medical prescription for cannabis, subject must agree to abstain during the entirety of the study and to have a negative test at baseline), cocaine, barbiturates, opiates. A positive benzodiazepine result will be allowed if there is a valid and prescribed medical use for these agents. For all other positive results, a single re-test is permitted at the judgement of the investigator; results of any retest must be available prior to the baseline visit and must be negative.
- In poor general health, as ascertained by medical history, physical examination (including measurement of vital signs), clinical laboratory evaluations, and 12-lead electrocardiogram (ECG).
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Crossover, Proof-of-Concept Phase 2 Study to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
This is a randomized, double-blind, placebo-controlled, crossover, proof-of-concept Phase 2 study to test efficacy and safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease subjects with levodopa-induced dyskinesia. The trial will be conducted in two treatment periods, in which each treatment period will consist of 14 days. The two treatment periods will be separated by a 1-week washout period. During the first treatment period, subjects meeting all eligibility criteria will be randomly assigned to receive either 1440 mg AV-101 or placebo in a 1:1 ratio. AV-101 or placebo will be administered BID for 14 days (every 12 hours). After the washout period, all subjects will be crossed over to receive the alternate treatment during the second treatment period (14-day period).
On the last day of each treatment period (Visit 4 [Day 14] and Visit 7 [Day35]), subjects will be assessed in clinic while in the practically "off" state and will receive the morning dose of the study drug at the clinic. This will be followed, within 25-30 minutes, by oral administration of a dose of levodopa that is 150% of the subject's normal dose. Assessments of dyskinesia and PD motor symptoms will be performed before and after levodopa/carbidopa administration.
- Conditions
- Parkinson Disease, Dyskinesia, Medication-Induced, L-Dopa Causing Adverse Effects in Therapeutic Use
- Being tested
- AV-101, Placebo
- Medical subject headings
- Parkinson Disease, Dyskinesia, Drug-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-101Drug
Also called L-4-chlorokynurenine
Oral capsules taken twice daily for 14 days
PlaceboDrug
Oral capsules taken twice a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| AV-101 | Experimental | 1440 mg of L-4-chlorokynurenine administered twice a day orally Receives: Drug: AV-101 |
| Placebo | Placebo comparator | Matching capsules of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Dyskinesia Rating Scale
(UDysRS) Part 3 AUC
Measured: 14 days
Unified Dyskinesia Rating Scale
(UDysRS) Part 3 Peak Score
Measured: 14 days
Secondary outcomes (1)
Movement Disorder Society- Unified Parkinson's Disease Rating Scale
(MDS-UPDRS) part III (Parkinsonian disability)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study startAug 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VistaGen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147949
- Sponsor's protocol ID
- VSG-CL-004
- Status last verified
- May 2021
- First submitted
- 27 Oct 2019
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Crossover, Proof-of-Concept Phase 2 Study to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
- ClinicalTrials.gov ID
- NCT04147949
- Acronym / sponsor ID
- VSG-CL-004
- Conditions
- Parkinson Disease, Dyskinesia, Medication-Induced, L-Dopa Causing Adverse Effects in Therapeutic Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- VistaGen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 1 Nov 2019 (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 randomized, double-blind, placebo-controlled, crossover, proof-of-concept Phase 2 study to test efficacy and safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease subjects with levodopa-induced dyskinesia. The trial will be conducted in two treatment periods, in which each treatment period will consist of 14 days. The two treatment periods will be separated by a 1-week washout period. During the first treatment period, subjects meeting all eligibility criteria will be randomly assigned to receive either 1440 mg AV-101 or placebo in a 1:1 ratio. AV-101 or placebo will be administered BID for 14 days (every 12 hours). After the washout period, all subjects will be crossed over to receive the alternate treatment during the second treatment period (14-day period).
On the last day of each treatment period (Visit 4 [Day 14] and Visit 7 [Day35]), subjects will be assessed in clinic while in the practically "off" state and will receive the morning dose of the study drug at the clinic. This will be followed, within 25-30 minutes, by oral administration of a dose of levodopa that is 150% of the subject's normal dose. Assessments of dyskinesia and PD motor symptoms will be performed before and after levodopa/carbidopa administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AV-101 | Experimental | Drug: AV-1011440 mg of L-4-chlorokynurenine administered twice a day orally |
| Placebo | Placebo comparator | Drug: PlaceboMatching capsules of placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female adults, 30 to 80 years of age, inclusive.
- Diagnosis of idiopathic PD meeting the United Kingdom Parkinson's disease Society Brain Bank criteria.
- Levodopa-induced dyskinesia present greater than 25% of the day as per MDS-UPDRS.
- Dyskinesia of at least moderate severity as per MDS-UPDRS
- Subjects currently receiving anti-parkinsonian medications that contain levodopa and carbidopa are eligible provided they have been on a stable dose of these medications for at least 1 month prior to randomization.
Key exclusion criteria (9 listed)
- Women with childbearing potential who are not willing to use one of the specified forms of birth control during the study or whose partner is unwilling to use a condom.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test at screening or baseline.
- Currently taking a prohibited adjunct therapy such amantadine or monoamine oxidase (MAO) inhibitors must be discontinued at least 3 weeks prior to baseline.
- Subject had a prior surgery for PD except Deep Brain Stimulation (Deep Brain Stimulation must not have been performed within one year of screening)
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 |
|---|---|---|
| AV-101Also: L-4-chlorokynurenineOral capsules taken twice daily for 14 days | Drug | AV-101 |
| PlaceboOral capsules taken twice a day for 14 days | Drug | Placebo |
Primary outcome
Unified Dyskinesia Rating Scale
Time frame: 14 days
(UDysRS) Part 3 AUC
Unified Dyskinesia Rating Scale
Time frame: 14 days
(UDysRS) Part 3 Peak Score
1 secondary outcome
Movement Disorder Society- Unified Parkinson's Disease Rating Scale
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: No
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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 AV-101 in people with Parkinson Disease and Dyskinesia, Medication-Induced, run by VistaGen Therapeutics, Inc..
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 11 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 May 2021. 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?
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?
Unified Dyskinesia Rating Scale (time frame: 14 days). The study lists 2 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 26 May 2021.