Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03058562
Other study ID # ABX-1431_PN015
Secondary ID
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
Health authority
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.

Study Design


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)
See also
  Status Clinical Trial Phase
Recruiting NCT04851678 - Longitudinal Impact of Stressors in Adults With Tourette Syndrome
Completed NCT02605902 - Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders N/A
Completed NCT04007913 - Incorporating teleCBIT Into a Hospital-Based Tic Program N/A
Completed NCT02900144 - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) N/A
Completed NCT02256475 - Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome Phase 1
Completed NCT02216474 - Brain Stimulation in Movement Disorders N/A
Completed NCT01329198 - Brain Stimulation for the Treatment of Tourette Syndrome N/A
Terminated NCT00952601 - Pilot Study of the Modified Atkins Diet for Tourette Syndrome Phase 1
Enrolling by invitation NCT00355927 - Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. N/A
Completed NCT00206323 - A Randomized, Placebo-controlled, Tourette Syndrome Study. Phase 3
Completed NCT00004376 - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder Phase 3
Completed NCT04498364 - Extinction Learning in Adults With Tourette Syndrome N/A
Completed NCT00755339 - Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
Completed NCT03325010 - Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome Phase 2
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Completed NCT01702077 - Neurofeedback for Tourette Syndrome N/A
Completed NCT01719523 - Open-Trial of EPI-743 for Adults With Tourette Syndrome Phase 1
Completed NCT00231985 - Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder Phase 2
Completed NCT00206336 - An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. Phase 3
Terminated NCT03732534 - Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome Phase 2