AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia

• Register: ClinicalTrials.gov
• Last refreshed on: 7 June 2021
• Main ID: NCT04147949
• Date of registration: 27/10/2019
• Prospective Registration: Yes
• Primary sponsor: VistaGen Therapeutics, Inc.
• Public title: AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
• Scientific 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
• Date of first enrolment: August 2022
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04147949
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female adults, 30 to 80 years of age, inclusive.

2. Diagnosis of idiopathic PD meeting the United Kingdom Parkinson's disease Society
Brain Bank criteria.

3. Levodopa-induced dyskinesia present greater than 25% of the day as per MDS-UPDRS.

4. Dyskinesia of at least moderate severity as per MDS-UPDRS

5. 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.

6. Subjects currently receiving antidepressants such as selective serotonin reuptake
inhibitors, provided the dose has been stable for at least 1 month prior to
randomization.

7. If female, a status of non-childbearing potential or use of an acceptable form of
birth control per the following specific criteria:

1. 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

2. . 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.

ii. 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.

iii. Male partner must use a condom.

Exclusion Criteria:

1. 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.

2. Women who are pregnant or breastfeeding.

3. Women with a positive pregnancy test at screening or baseline.

4. Currently taking a prohibited adjunct therapy such amantadine or monoamine oxidase
(MAO) inhibitors must be discontinued at least 3 weeks prior to baseline.

5. Subject had a prior surgery for PD except Deep Brain Stimulation (Deep Brain
Stimulation must not have been performed within one year of screening)

6. Hoehn and Yahr score of 5 when "off".

7. Subject with Cognitive impairment and/or history of psychiatric manifestations or
active hallucinations.

8. 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.

9. In poor general health, as ascertained by medical history, physical examination
(including measurement of vital signs), clinical laboratory evaluations, and 12-lead
electrocardiogram (ECG).



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dyskinesia, Medication-Induced

L-Dopa Causing Adverse Effects in Therapeutic Use

Parkinson Disease

Intervention(s)

Drug: AV-101

Drug: Placebo

Primary Outcome(s)

Unified Dyskinesia Rating Scale [Time Frame: 14 days]

Secondary Outcome(s)

Movement Disorder Society- Unified Parkinson's Disease Rating Scale [Time Frame: 14 days]

Secondary ID(s)

VSG-CL-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors