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

NCT03058562 | Completed Phase 1

• 1 other identifier: ABX-1431_PN015
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome; Chronic Motor Tic Disorder

Outcome Measures

Primary Outcomes (4)

• Change of rating in Modified Rush Video Scale (MRVS) over time

  pre-dose, post-dose (4 hours, 8 hours)

• Change in rating of Yale Global Tic Severity Scale (YGTSS) over time

  pre-dose, post-dose (4 hours, 8 hours)

• Change of rating in Adult Tic Questionnaire (ATQ) over time

  pre-dose, post-dose (4 hours, 8 hours, 12 hours)

• Change of rating in Premonitory Urge for Tics Scale (PUTS) over time

  pre-dose, post-dose (4 hours, 8 hours, 12 hours)

Secondary Outcomes (6)

• ABX-1431 and metabolite (M55) plasma pharmacokinetics

  pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours)

• 2-AG hydrolysis in PBMC

  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)

  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

  screening, pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours)

• Number of patients with clinically significant change in Laboratory safety tests

  screening, pre-dose, post-dose (24 hours)

Study Arms (4)

Crossover Sequence A

EXPERIMENTAL

Each in the fasting state: Period 1: Single-dose matching placebo Period 2: Single-dose ABX-1431

Drug: ABX-1431; Drug: Placebo Comparator

Crossover Sequence B

EXPERIMENTAL

Each in the fasting state: Period 1: Single-dose ABX-1431 Period 2: Single-dose matching placebo

Drug: ABX-1431; Drug: Placebo Comparator

Crossover Sequence C

EXPERIMENTAL

Each with a standard high fat meal: Period 3: Single-dose matching placebo Period 4: Single-dose ABX-1431

Drug: Placebo Comparator; Drug: ABX-1431

Crossover Sequence D

EXPERIMENTAL

Each with a standard high fat meal: Period 3: Single-dose ABX-1431 Period 4: Single-dose matching placebo

Drug: Placebo Comparator; Drug: ABX-1431

Interventions

ABX-1431 DRUG

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

Crossover Sequence A; Crossover Sequence B

Placebo Comparator DRUG

Matching Placebo

Crossover Sequence A; Crossover Sequence B; Crossover Sequence C; Crossover Sequence D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abide Therapeutics: lead

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Tourette Syndrome

Interventions

ABX-1431

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Chan Beals

  Abide Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 23, 2017
• Study Start: February 1, 2017
• Primary Completion: October 4, 2017
• Study Completion: October 4, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)