A Phase 1 interventional study of ABX-1431 and Placebo Comparator in Tourette Syndrome and Chronic Motor Tic Disorder, sponsored by Abide Therapeutics. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Abide Therapeutics (part of H. Lundbeck A/S) · Phase 1, Interventional, and Basic science
Among 21 studies in Tourette Syndrome with a site in Germany — 1 open to participants now, 2 under way, none of them phase 3. Tourette Syndrome · Germany.
Among the 21 studies in Tourette Syndrome with a site in Germany, this one is the 18th largest by enrollment of the 19 interventional ones that give a count, is the only one that started in 2017, is the only one in phase 1, and was the 10th registered.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
Browse Tourette Syndrome studies →1 of the 21 studies in Tourette Syndrome with a site in Germany is open now. Recruiting first, the newest first:
Neurothera Labs Inc. · Sites in Germany, United States, Israel
Ages 18–65
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 33 Tourette Syndrome studies recruiting now, 9 (27%) set no upper age limit and 22 (67%) stop at 75 or younger; 20 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 8 · Phase 3 7
First in 2008; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 23 is below the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Median enrollment 98 across the 19 interventional studies, 53 across the 2 observational. Of the 15 that completed or were terminated, 8 (53%) have results posted.
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13 of 21 have an industry lead sponsor. The 10 most frequent:
This study is registered under Abide Therapeutics, one of the names counted as H. Lundbeck A/S. Under that name alone:
Abide Therapeutics is the lead sponsor of 6 studies on the registry; none are open to participants now.
H. Lundbeck A/S has 2 studies filed under Tourette Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Tourette Syndrome with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05126888Neurothera Labs Inc.SCI-110 in the Treatment of Tourette Syndrome | 2027-10 |
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Among the 21 studies in Tourette Syndrome with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Principal Inclusion Criteria:
Principal Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each in the fasting state: Period 1: Single-dose matching placebo Period 2: Single-dose ABX-1431
Drug: ABX-1431 · Drug: Placebo Comparator
Each in the fasting state: Period 1: Single-dose ABX-1431 Period 2: Single-dose matching placebo
Drug: ABX-1431 · Drug: Placebo Comparator
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
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
Change of rating in Modified Rush Video Scale (MRVS) over time
Time frame: pre-dose, post-dose (4 hours, 8 hours)
Change in rating of Yale Global Tic Severity Scale (YGTSS) over time
Time frame: pre-dose, post-dose (4 hours, 8 hours)
Change of rating in Adult Tic Questionnaire (ATQ) over time
Time frame: pre-dose, post-dose (4 hours, 8 hours, 12 hours)
Change of rating in Premonitory Urge for Tics Scale (PUTS) over time
Time frame: pre-dose, post-dose (4 hours, 8 hours, 12 hours)
ABX-1431 and metabolite (M55) plasma pharmacokinetics
Time frame: pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours)
2-AG hydrolysis in PBMC
Time frame: 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)
Time frame: 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
The following vital signs will be assessed: heart rate, blood pressure, respiratory rate, temperature
Time frame: screening, pre-dose, post-dose (2 hours, 4 hours, 8 hours, 24 hours)
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
Time frame: screening, pre-dose, post-dose (24 hours)
12-lead ECG assessments
Time frame: screening, pre-dose, post-dose (4 hours)
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2017 to primary completion in Oct 2017, 8 months.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ABX-1431