Study to Assess the Safety, Tolerability and Preliminary Efficacy of NLX-112 Versus Placebo in L-dopa-induced Dyskinesia

  • STATUS
    Recruiting
  • End date
    Nov 17, 2022
  • participants needed
    24
  • sponsor
    Neurolixis SAS
Updated on 10 March 2022
dyskinesia
dopa

Summary

This is a study evaluating the safety, tolerability, and effectiveness of a medication for individuals with moderate to severe L-DOPA induced dyskinesia (LID) in Parkinson's disease (PD). The treatment will be administered over a total of 8 weeks. 

Description

This is a study evaluating the safety, tolerability, and effectiveness of a medication for individuals with moderate to severe L-DOPA induced dyskinesia (LID) in Parkinson's disease (PD). The treatment will be administered over a total of 8 weeks. 

Patients will report to the study clinic for a screening visit (Visit 1), followed by a baseline visit (Visit 2) where they will be randomly selected into the treatment or control group and begin taking the medication, if all eligibility criteria are met. For every two patients selected into the treatment group, one patient will be selected into the control group. After enrollment, and treatment begins, there will be seven visits with the clinic, two by telephone (Visits 3 and 8), and 5 in person at the clinic (Visits 4, 5, 6, 7 and 9). Visit 9 is the final visit and will occur approximately 14 days after treatment ends.

At Visits 2, 6 and 7, assessments will start 30 minutes after the patient has taken a higher dose of their regular L-DOPA medication, when the patient is ON and experiencing typical dyskinesia.

An electronic PD Home Dyskinesia Diary will be completed by the patient and/or their caregiver while in ON time with dyskinesia. ON time with dyskinesia criteria will be agreed upon between patient, caregiver, and study staff. Two consecutive 24-hour diaries will be completed prior to Visit 2, and prior to in-person visits 6 and 7.
A wearable dyskinesia assessment device will be used to monitor dyskinesia during a 2-day period before Visit 2, and a 2-day period before in-person visits 6 and 7.

Blood will be collected for safety laboratory measurements at all in-clinic visits. A separate blood sample will be collected for drug plasma measurements on Visits 4, 5, 6, 7 and 9.

Details
Condition Medication-Induced Dyskinesia, Parkinson's disease
Treatment Placebo, NLX-112
Clinical Study IdentifierNCT05148884
SponsorNeurolixis SAS
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Patient is 30 - 85 years old (inclusive) with a diagnosis of idiopathic PD
according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis
criteria
\. PD patient is stably being treated with L-DOPA; other anti-PD treatments
are allowed if used continuously for at least 4 weeks
\. Patient agrees to receive an increased dose of their normal L-DOPA
medication (maximum L-DOPA dose 250 mg) 30 minutes prior to assessments during
Visits 2, 6, and 7
Females of non-childbearing potential are defined as pre-menopausal females
\. PD patient receives a score of at least 1 on Part IV, item 33 of the
Unified Parkinson’s Disease Rating Scale at Visits 1 and 2
\. Patient records at least two 30-minute time periods between 9 am to 4 pm
and at least 90 minutes total each day (24 hours), of “ON with troublesome
dyskinesia” in the PD Home Dyskinesia Diary prior to Visit 2
\. Patient (and/or caregiver) demonstrates ability to accurately complete the
PD Home Dyskinesia Diary entries during Visit 1
\. Patient can read well enough to understand the informed consent document
and other subject materials
\. Female patients of child-bearing potential must have a negative urine
pregnancy test at Visits 1 and 2. Patients must agree to avoid pregnancy
during the study, either through practicing abstinence (only if this is the
preferred and usual lifestyle of the subject) or via use of a highly effective
method of contraception with a failure rate of < 1% to prevent pregnancy
Examples include a combined hormonal contraception associated with stopping
ovulation, progestogen-only hormonal contraception associated with stopping
ovulation, an intrauterine device [IUD] or an intrauterine hormone-releasing
system [IUS]. The form of contraception must start 4 weeks before being given
the study medication, and continue for 4 weeks after the last dose of the
study medication. Female subjects must agree to not donate eggs until 3 months
after receiving the medication. Any male partners must agree to use a condom
during the study period if he has not undergone a vasectomy
who are sterile, who have undergone a hysterectomy or other ovarian removal
procedure, or who are post-menopausal, defined as 12 months without
menstruation. (In cases where post-menopausal may be questionable, a blood
sample can be used to confirm)
Male patients must have either had a vasectomy, agree to use a condom or
practice abstinence, and agree to not donate sperm until 3 months after
receiving the medication. Any female partners of child-bearing potential must
use a highly effective form of birth control to prevent pregnancy (see above)
during the same study period

Exclusion Criteria

\. Patient has severe PD with a Hoehn and Yahr stage (a commonly used system
for describing how the symptoms of Parkinson's disease progress) equal to 5
\. Patient has unstable medical status, prior brain surgery (excluding deep
brain stimulation [DBS], meaning DBS patients will be allowed to be enrolled)
or is scheduled to receive brain surgery during the trial period
\. Patient has orthostatic hypotension, defined as a decrease in systolic
blood pressure (at least 20 mm Hg) or diastolic blood pressure (at least 10 mm
Hg) within 2 minutes of the patient standing up, compared to pressures
obtained while the patient is laying on their back for at least 5 minutes. At
Visits 1 and 2, vital signs to assess orthostatic hypotension will be
conducted three times, 15-20 minutes apart, with the average of the 3
assessments used for determining orthostatic hypotension status
\. Patient has dementia (Mini-Mental State Examination <20)
\. Patient has clinically significant renal or liver disorder
\. Patient currently exhibits generalized obsessive-compulsive disorder
panic disorder, bipolar disorder, post-traumatic stress syndrome (PTSD)
clinically significant parasomnias or any other psychotic disorder as
established by the DSM. Visual hallucinations are allowed
\. Any suicidal actions in the past 2 years (per investigator judgement i.e
actual attempt, interrupted attempt, aborted attempt, or preparatory acts or
behavior)
\. Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity
Rating Scale in the past 3 months (i.e., active suicidal thought with intent
but without specific plan, or active suicidal thought with plan and intent)
\. Patient has taken an anti-convulsant, an anti-psychotic (except
quetiapine), pindolol, tertatolol or buspirone within 4 weeks of Visit 2
\. Patient has taken any medication within 4 weeks of Visit 2 that stops or
increases CYP4503A4
\. Patient is participating in another investigational drug trial or has
participated in another investigational drug trial within the past 3 months
\. Patient is at high risk of non-compliance in the Investigator's opinion
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