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

Sponsored by Abide Therapeutics

About this trial

Last updated 8 years ago

Study ID

ABX-1431_PN015

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the Participation Requirements?

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.

Locations

Location

Status