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Trial record 4 of 6 for:    ABX-1431

A Study to Evaluate the Effects of ABX-1431 on Patients With Tourette Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03058562
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Abide Therapeutics

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date November 6, 2017
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date October 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
  • Change of rating in Modified Rush Video Scale (MRVS) over time [ Time Frame: pre-dose, post-dose (4 hours, 8 hours) ]
  • Change in rating of Yale Global Tic Severity Scale (YGTSS) over time [ Time Frame: pre-dose, post-dose (4 hours, 8 hours) ]
  • Change of rating in Adult Tic Questionnaire (ATQ) over time [ Time Frame: pre-dose, post-dose (4 hours, 8 hours, 12 hours) ]
  • Change of rating in Premonitory Urge for Tics Scale (PUTS) over time [ Time Frame: pre-dose, post-dose (4 hours, 8 hours, 12 hours) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03058562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
  • ABX-1431 and metabolite (M55) plasma pharmacokinetics [ Time Frame: pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours) ]
  • 2-AG hydrolysis in PBMC [ Time Frame: pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours) ]
  • Number and severity of adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs) [ Time Frame: screening, pre-dose, post-dose (0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours), follow-up ]
  • Number of patients with clinically significant change in vital signs [ Time Frame: screening, pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours) ]
    The following vital signs will be assessed: heart rate, blood pressure, respiratory rate, temperature
  • Number of patients with clinically significant change in Laboratory safety tests [ Time Frame: screening, pre-dose, post-dose (24 hours) ]
    The following laboratory safety tests will be assessed: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Albumin, Alkaline phosphatase, Bicarbonate, Calcium, Chloride, Cholesterol, Creatinine, Glucose, Potassium, Sodium, Bilirubin, total (bilirubin to be fractionated if total bilirubin is elevated), Blood urea nitrogen (BUN)/Urea, hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell (WBC) count (total and differential count), polymorphonuclear leukocytes (neutrophils), lymphocytes, eosinophils, monocytes, basophils; Urinalysis: pH, specific gravity, glucose, ketones, leukocyte, esterase, nitrites, occult blood, protein
  • 12-lead ECG assessments [ Time Frame: screening, pre-dose, post-dose (4 hours) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effects of ABX-1431 on Patients With Tourette Syndrome
Official Title  ICMJE A Randomized, Placebo-Controlled, Single-Dose Crossover Study of ABX-1431 HCl in Adult Patients With Tourette Syndrome (TS) and Chronic Motor Tic Disorder
Brief Summary

The study will investigate the effects and the safety of a single-dose of ABX-1431 HCl on tics and other symptoms of Tourette Syndrome.

During part 1 (periods 1 and 2) each patient will receive study drug once and placebo once.

Patients who complete part 1 with adequate clinical safety will be offered the option to participate in part 2 (periods 3 and 4) and again willl receive study drug once and placebo once where, in contrast to part 1, administration will take place with a standard high fat meal.

Detailed Description

This is a single dose, double-blind, randomized, placebo-controlled, cross-over study. This study will assess the single dose effects of ABX-1431 HCl on tics and other symptoms of Tourette Syndrome.

All patients will undergo a screening visit for enrollment criteria. Eligible patients will be treated with a single dose of ABX-1431 HCl or placebo followed by efficacy, safety and pharmacokinetics assessments. After a washout period of 1-3 weeks, patients will undergo identical procedures with the other treatment.

Only patients who complete the first part of the study with adequate clinical safety will be offered the option to participate in an additional two period crossover, where ABX-1431 HCl or placebo is taken with a standard high fat meal. Again, efficacy, safety and pharmacokinetics assessments will be done. After a washout period of 1-3 weeks, patients will undergo identical procedures with the other treatment.

This study will enroll 20 patients with a diagnosis of Tourette Syndrome OR chronic motor tic disorder.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Tourette Syndrome
  • Chronic Motor Tic Disorder
Intervention  ICMJE
  • Drug: ABX-1431
    ABX-1431, capsules, 40 mg in the fasting state
  • Drug: Placebo Comparator
    Matching Placebo
  • Drug: ABX-1431
    ABX-1431, capsules, 20 mg with a high fat meal
Study Arms  ICMJE
  • Experimental: Crossover Sequence A

    Each in the fasting state:

    Period 1: Single-dose matching placebo

    Period 2: Single-dose ABX-1431

    Interventions:
    • Drug: ABX-1431
    • Drug: Placebo Comparator
  • Experimental: Crossover Sequence B

    Each in the fasting state:

    Period 1: Single-dose ABX-1431

    Period 2: Single-dose matching placebo

    Interventions:
    • Drug: ABX-1431
    • Drug: Placebo Comparator
  • Experimental: Crossover Sequence C

    Each with a standard high fat meal:

    Period 3: Single-dose matching placebo

    Period 4: Single-dose ABX-1431

    Interventions:
    • Drug: Placebo Comparator
    • Drug: ABX-1431
  • Experimental: Crossover Sequence D

    Each with a standard high fat meal:

    Period 3: Single-dose ABX-1431

    Period 4: Single-dose matching placebo

    Interventions:
    • Drug: Placebo Comparator
    • Drug: ABX-1431
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2017)
23
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2017)
20
Actual Study Completion Date  ICMJE October 4, 2017
Actual Primary Completion Date October 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Principal Inclusion Criteria:

  • Patient is a male or female between the age of 18 and 65 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 Yale Global Tic Severity Scale (YGTSS) total tic sub-scale (TTS) results must be ≥ 18 (Range 0-50) at the Screening Visit.
  • Patients taking daily medications for symptoms of Tourette Syndrome [e.g. neuroleptics (e.g. aripiprazole, risperidone) or selective serotonin reuptake inhibitors (e.g. fluoxetine)] must be on a stable dose of medication for at least 30 days before the Screening Visit and must be expected to remain on a stable dose during this study.

Principal Exclusion Criteria:

  • Patient is taking potent cytochrome P450 3A4/5 inducers [e.g. carbamazepine, oxcarbazine, rifampin, St. John's Wort (Hypericum perforatum), or phenytoin]. Patient is taking strong P450 3A4/5 inhibitors including atazanavir, bocepravir, clarithromycin, grapefruit juice, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, or voriconazole.
  • Patients with a diagnosis of any psychiatric comorbidity (obsessive compulsive disorder, attention deficit hyperactivity disorder) OR generalized anxiety disorder, depression or post-traumatic stress disorder that is unstable or requires alteration in therapy are excluded. Patients with a past history of psychosis or schizophrenia at any time are excluded. Patients with stable OCD or ADHD requiring no alteration in therapy may be enrolled.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03058562
Other Study ID Numbers  ICMJE ABX-1431_PN015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abide Therapeutics
Study Sponsor  ICMJE Abide Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chan Beals Abide Therapeutics, Inc.
PRS Account Abide Therapeutics
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP