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

NCT ID: NCT03058562

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-10-04

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.

Conditions

Tourette Syndrome; Chronic Motor Tic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Crossover Sequence A

Each in the fasting state:

Period 1: Single-dose matching placebo

Period 2: Single-dose ABX-1431

Group Type: EXPERIMENTAL

ABX-1431

Intervention Type: DRUG

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

Placebo Comparator

Intervention Type: DRUG

Matching Placebo

Crossover Sequence B

Each in the fasting state:

Period 1: Single-dose ABX-1431

Period 2: Single-dose matching placebo

Group Type: EXPERIMENTAL

ABX-1431

Intervention Type: DRUG

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

Placebo Comparator

Intervention Type: DRUG

Matching Placebo

Crossover Sequence C

Each with a standard high fat meal:

Period 3: Single-dose matching placebo

Period 4: Single-dose ABX-1431

Group Type: EXPERIMENTAL

Placebo Comparator

Intervention Type: DRUG

Matching Placebo

ABX-1431

Intervention Type: DRUG

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

Crossover Sequence D

Each with a standard high fat meal:

Period 3: Single-dose ABX-1431

Period 4: Single-dose matching placebo

Group Type: EXPERIMENTAL

Placebo Comparator

Intervention Type: DRUG

Matching Placebo

ABX-1431

Intervention Type: DRUG

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

Interventions

ABX-1431

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

Intervention Type: DRUG

Placebo Comparator

Matching Placebo

Intervention Type: DRUG

ABX-1431

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

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abide Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chan Beals

Role: STUDY_DIRECTOR

Abide Therapeutics, Inc.

Locations

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Countries

Germany

Other Identifiers

ABX-1431_PN015

Identifier Type: -

Identifier Source: org_study_id