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

Tourette Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058562
• Other study ID #: ABX-1431_PN015
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2017
• Last updated: November 2, 2017
• Start date: February 1, 2017
• Est. completion date: October 4, 2017

Study information

• Verified date: November 2017
• Source: Abide Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 4, 2017
• Est. primary completion date: October 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Motor Tic Disorder
• Syndrome
• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Drug:
• ABX-1431
ABX-1431, capsules, 40 mg in the fasting state
• Placebo Comparator
Matching Placebo
• ABX-1431
ABX-1431, capsules, 20 mg with a high fat meal

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Abide Therapeutics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of rating in Modified Rush Video Scale (MRVS) over time		pre-dose, post-dose (4 hours, 8 hours)
Primary	Change in rating of Yale Global Tic Severity Scale (YGTSS) over time		pre-dose, post-dose (4 hours, 8 hours)
Primary	Change of rating in Adult Tic Questionnaire (ATQ) over time		pre-dose, post-dose (4 hours, 8 hours, 12 hours)
Primary	Change of rating in Premonitory Urge for Tics Scale (PUTS) over time		pre-dose, post-dose (4 hours, 8 hours, 12 hours)
Secondary	ABX-1431 and metabolite (M55) plasma pharmacokinetics		pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours)
Secondary	2-AG hydrolysis in PBMC		pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours)
Secondary	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
Secondary	Number of patients with clinically significant change in vital signs	The following vital signs will be assessed: heart rate, blood pressure, respiratory rate, temperature	screening, pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours)
Secondary	Number of patients with clinically significant change in Laboratory safety tests	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	screening, pre-dose, post-dose (24 hours)
Secondary	12-lead ECG assessments		screening, pre-dose, post-dose (4 hours)