Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder (NCT03625453) | Clinical Trial Compass
CompletedPhase 2
Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder
Germany50 participantsStarted 2018-10-15
Plain-language summary
Two-part study consisting of a double-blind, randomized, placebo-controlled, study at two target dose levels (Part 1) and an open-label, non-randomized study (Part 2) to determine the efficacy of ABX-1431 in treating adult patients with Tourette syndrome or Chronic Motor Tic Disorder as measured by the change from baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) compared with placebo.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient is a male or female ≥ 18 to 64 years of age at the Screening Visit.
✓. Patient has a diagnosis of Tourette Syndrome or Chronic Motor Tic Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
✓. Patient's YGTSS-TTS results must be ≥ 22 (range 0-50) at the Baseline/Randomization Visit.
✓. At the Baseline/Randomization Visit patients must be taking a stable drug regimen for tics and comorbidities for 30 days and must be expected to remain on a stable drug regimen during this study. Patients receiving no medication for TS may participate. Patients who have recently discontinued medication for tics must have discontinued them for at least 30 days. For neuroleptic drugs (e.g., risperidone, aripiprazole), the minimum discontinuation period is 30 days prior to the Baseline/Randomization Visit. For injectable depot neuroleptic drugs the minimum discontinuation period is one dosage cycle plus 14 days. (See Inclusion 'f' for discontinuation period of cannabinoid medication in patients using these products for tics.)
✓. Patient is legally competent, has been informed of the nature and scope of relevance for the study, voluntarily agrees to participation, agrees to the study restrictions, and has signed the informed consent form (ICF) approved by the Ethics Review Committee (ERC).
✓. Patients using cannabinoid medications for their tics must discontinue their use at least 14 days prior to the Baseline/Randomization Visit. The investigator and patient must be confident that these patients will not require these medications for the duration of the study until 14 days after the last dose of study medication. Examples of cannabinoids include cannabis in any form, nabilone or Δ9-tetrahydrocannabinol (THC)-containing medications such as nabiximols (Sativex®) or dronabinol. The use of recreational cannabinoids during this study is not permitted.
✓. Female patients of child-bearing potential must have a negative pregnancy test \[serum or urine human chorionic gonadotropin (hCG)\] at the Screening Visit and other indicated visits. They must practice a highly effective, reliable, and medically approved contraceptive regimen during the study (e.g., theoretical failure rate less than 1% per year as described in the 2014 Heads of Medicines Agencies: Clinical Trials Facilitation Group report on contraception in clinical trials, which include oral or parenteral or implanted hormonal contraception, vaginal ring releasing hormonal contraception (e.g., Nuvaring, intrauterine device, or intrauterine system). Post-menopausal women may enter this study. Post-menopausal women are defined as those without menses in the past 12 months, and with a serum follicle stimulating hormone (FSH) in the post-menopausal range. Women who are surgically sterile may enter this study with written documentation of the surgical procedure.
What they're measuring
1
Change from baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) compared with placebo
Timeframe: Day 56 (40 mg ABX-1431 per day) and Day 28 (20 mg ABX-1431 per day)
✓. Male patients must be willing to use a condom with sexual partners during this study until 14 days after the last dose of study medication. Male patients must be willing to abstain from sperm donation for 3 months after the completion of this study.
Exclusion criteria
✕. Patient is taking strong inducers or inhibitors of cytochrome P450 (CYP)3A4/5 or CYP2C9. Examples of strong CYP3A4/5 inducers include carbamazepine, efavirenz, nevirapine, barbiturates, pioglitazone, modafinil, enzalutamide, oxcarbazepine, rifampicin, St. John's Wort (Hypericum perforatum), and phenytoin. Examples of potent CYP3A4/5 inhibitors include atazanavir, boceprevir, clarithromycin, grapefruit juice, indinavir, itraconazole, ketoconazole, nefazodone, suboxone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, and voriconazole. Examples of CYP2C9 strong inducers/inhibitors include carbamazepine, enzalutamide, fluconazole, valproic acid, phenobarbital, nevirapine, rifampicin, and St. John's Wort.
✕. Patient has evidence of alcohol abuse or dependence, as defined by the DSM-5 criteria, with two or more of the 11 criteria at the Screening Visit or within 1 year before the Screening Visit.
✕. Patient has evidence of drug or chemical abuse (except nicotine), as defined by the DSM-5 criteria, at the Screening Visit or within 1 year before the Screening Visit. Patient has evidence of marijuana or cannabis dependency or has been treated for cannabis dependency, as defined by DSM-5 criteria, at the Screening Visit or within 1 year before the Screening Visit. (Patients who are prescribed stimulants should not be assessed for Stimulant Use Disorder. Patients who use cannabinoid-based medicine (e.g., cannabis in any form, nabilone, or THC-containing medications) for treatment of Tourette Syndrome with the investigator's knowledge should not be assessed for Cannabis Use Disorder, but these patients must comply with abstinence requirements for this study (See Inclusion 'f')). Patients who have a positive urine drug screen at the Screening Visit for drugs other than those allowed, as indicated in this criterion, are excluded.
✕. Patient is unwilling to comply with study restrictions including abstinence from cannabis and alcohol from the Baseline/Randomization Visit until the follow-up telephone call 14 days after the last dose of study medication.
✕. Patients receiving ongoing psychological therapy for tics such as Habit Reversal Training or Comprehensive Behavioral Intervention for Tics are excluded. Patients who have completed behavioral therapy for tics at least 30 days before the Baseline/Randomization Visit may participate.
✕. Patient is a lactating or pregnant female, or a female who intends to become pregnant within 90 days following the last dose of study medication.
✕. Patient has one or more of the following laboratory results at the Screening Visit:
✕. Patient has an estimated creatinine clearance less than 60 mL/minute at the Screening Visit. Creatinine clearance (Clcr) is estimated by the Cockcroft-Gault (C-G) equation from a spot serum creatinine (mg/dL) determination using the following formula: