Trial · NCT03625453
Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder
NCT03625453, Phase 2, Completed, Abide Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder. Trials, record NCT03625453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03625453
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder
- NCT number
- NCT03625453
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Abide Therapeutics
- Conditions
- Tourette Syndrome, Motor Tic Disorder
- Interventions
- ABX-1431, Placebo
- First posted
- 2018-08-10
- Last updated
- 2020-04-08
- Other registries' IDs
- eudract:2018-000100-41
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) compared with placebo | Day 56 (40 mg ABX-1431 per day) and Day 28 (20 mg ABX-1431 per day) | The Yale Global Tourette Severity Scale (YGTSS) is a clinician-completed rating scale to capture TS symptom severity. The number, frequency, intensity, complexity, and interference of both motor and vocal tics are rated on an ordinal scale between 0 and 5, with higher scores indicating greater severity. Motor and vocal tics subscales are reported (0 - 25) and then summed for a total tic score (TTS) (0 - 50). The TTS has been used as the registration endpoint for pharmacological therapies. The YGTSS has an Impairment subscale (0 - 50) which is then added for a total global score of 0 - 100. |
| Secondary | Adult Tic Questionnaire (ATQ) | Part 1: days 0, 14, 28, 42, 56; Part 2: days 0, 14, 28 | The Adult Tic Questionnaire (ATQ) is a tic self-rating scale. The ATQ records the occurrence, frequency and intensity for any of 27 endorsed common motor and vocal tics. The occurrence is being indicated as 1 for a present tic or 0 if no tic has been experienced. Frequency is measured on a scale from 1 (weekly frequency or less) to 4 (constant tics, almost all the time during the day). Intensity is being rated on a scale of 1 - 4 with 1 representing mild tics and 4 strong tics. The ATQ will principally be analyzed by summing the product of the intensity (1-4) and frequency (1-4) to determine the severity (2-8) across all endorsed tics. For clarity, the number of each endorsed tic and the total of intensity and frequency across all tics may be separately analyzed by mixed-model repeated-measures. The clinical relevance of changes in the ATQ may also be presented by the change in the average intensity and frequency score. |
| Secondary | Premonitory Urge for Tics Scale (PUTS) | Part 1: days 0, 14, 28, 42, 56; Part 2: days 0, 14, 28 | The Premonitory Urge for Tics Scale (PUTS) is a patient self-assessment of the intensity of agreement of several statements describing the unpleasant qualities of premonitory feelings preceding tics. Each statement is being rated on a scale from 1 (not at all) to 4 (very much). The total score is being calculated by summing the single scores. The range of the total score is between 9, corresponding to a minimal intensity of premonitory urges for tics and 36, an extremely high intensity with probable severe impairment. |
| Secondary | Clinical Global Impressions Scale for Improvement (CGII) | Part 1: days 14, 28, 42, 56; Part 2: days 14, 28 | The Clinical Global Impression of Improvement (CGI-I) is a 7-point ordinal, clinician-rated scale used to assess patients' overall improvement in disease status relative to their condition at baseline. A rating of 1 indicates a very much improved condition, compared to the subject's prior condition, while a rating of 7 means a very much worse condition respectively. |
| Secondary | AE occurrence | Throughout the study: Part 1: day - 30 to day 70; Part 2: day 0 to day 42 | All Adverse Events (AE) occurring during the clinical trial will be registered, documented and evaluated. |
| Secondary | SAE occurrence | Throughout the study: Part 1: day - 30 to day 70; Part 2: day 0 to day 42 | All Serious Adverse Events (SAE) occurring during the clinical trial will be registered, documented and evaluated. |
| Secondary | SUSAR occurrence | Throughout the study: Part 1: day - 30 to day 70; Part 2: day 0 to day 42 | All Serious Unexpected Serious Adverse Reactions (SUSAR) occurring during the clinical trial will be registered, documented and evaluated. |
| Secondary | Discontinuations due to AE occurrence | Throughout the study: Part 1: day - 30 to day 70; Part 2: day 0 to day 42 | All discontinuations due to (Adverse Events) AE occurring during the clinical trial will be evaluated. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34117788 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03625453
GET https://conductscience.org/api/trials/v1/NCT03625453/registered