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Trial record 6 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

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.


Condition or disease Intervention/treatment Phase
Tourette Syndrome Chronic Motor Tic Disorder Drug: ABX-1431 Drug: Placebo Comparator Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Placebo-Controlled, Single-Dose Crossover Study of ABX-1431 HCl in Adult Patients With Tourette Syndrome (TS) and Chronic Motor Tic Disorder
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : October 4, 2017
Actual Study Completion Date : October 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Crossover Sequence A

Each in the fasting state:

Period 1: Single-dose matching placebo

Period 2: Single-dose ABX-1431

Drug: ABX-1431
ABX-1431, capsules, 40 mg in the fasting state

Drug: Placebo Comparator
Matching Placebo

Experimental: Crossover Sequence B

Each in the fasting state:

Period 1: Single-dose ABX-1431

Period 2: Single-dose matching placebo

Drug: ABX-1431
ABX-1431, capsules, 40 mg in the fasting state

Drug: Placebo Comparator
Matching Placebo

Experimental: Crossover Sequence C

Each with a standard high fat meal:

Period 3: Single-dose matching placebo

Period 4: Single-dose ABX-1431

Drug: Placebo Comparator
Matching Placebo

Drug: ABX-1431
ABX-1431, capsules, 20 mg with a high fat meal

Experimental: Crossover Sequence D

Each with a standard high fat meal:

Period 3: Single-dose ABX-1431

Period 4: Single-dose matching placebo

Drug: Placebo Comparator
Matching Placebo

Drug: ABX-1431
ABX-1431, capsules, 20 mg with a high fat meal




Primary Outcome Measures :
  1. Change of rating in Modified Rush Video Scale (MRVS) over time [ Time Frame: pre-dose, post-dose (4 hours, 8 hours) ]
  2. Change in rating of Yale Global Tic Severity Scale (YGTSS) over time [ Time Frame: pre-dose, post-dose (4 hours, 8 hours) ]
  3. Change of rating in Adult Tic Questionnaire (ATQ) over time [ Time Frame: pre-dose, post-dose (4 hours, 8 hours, 12 hours) ]
  4. Change of rating in Premonitory Urge for Tics Scale (PUTS) over time [ Time Frame: pre-dose, post-dose (4 hours, 8 hours, 12 hours) ]

Secondary Outcome Measures :
  1. ABX-1431 and metabolite (M55) plasma pharmacokinetics [ Time Frame: pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours) ]
  2. 2-AG hydrolysis in PBMC [ Time Frame: pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours) ]
  3. 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 ]
  4. 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


  5. 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


  6. 12-lead ECG assessments [ Time Frame: screening, pre-dose, post-dose (4 hours) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058562


Locations
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Germany
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Abide Therapeutics
Investigators
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Study Director: Chan Beals Abide Therapeutics, Inc.

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Responsible Party: Abide Therapeutics
ClinicalTrials.gov Identifier: NCT03058562     History of Changes
Other Study ID Numbers: ABX-1431_PN015
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Tourette Syndrome
Tic Disorders
Tics
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms