Ecopipam for Tourette Syndrome
Recruiting in Palo Alto (17 mi)
+64 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Emalex Biosciences Inc.
Must be taking: Ecopipam
Must not be taking: Neuroleptics, Antidepressants, Anti-anxiety
Disqualifiers: Neurological conditions, Mood disorders, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to \[\>=\] 6 and less than \[\<\] 12 years of age), adolescents (\>=12 and \<18 years of age), and adults (\>=18 years of age) with Tourette's Syndrome (TS).
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications, including those for motor or vocal tics, antidepressants, anti-anxiety medications, and specific drugs like digoxin, fluoxetine, valproic acid, and bupropion, due to potential drug interactions with ecopipam.
What data supports the effectiveness of the drug Ecopipam for treating Tourette Syndrome?
Is ecopipam safe for humans?
Eligibility Criteria
This trial is for children (6+), adolescents, and adults with Tourette's Syndrome who have shown improvement on ecopipam. Participants must not have certain neurological conditions, unstable mood disorders, severe kidney or liver issues, or a recent history of substance abuse. Pregnant women and those unable to swallow tablets are excluded.Inclusion Criteria
Participants who completed the studies EBS-101-OL-001 or PSY302A
I have been diagnosed with Tardive Dyskinesia according to DSM-5 criteria.
I am between 6 and 18 years old.
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Exclusion Criteria
Participants who discontinued the studies PSY-302A, EBS-101-OL-001 or EBS-101-TD-301 due to reasons such as lost to follow up, withdrawn consent, non-compliant or withdrawn by the discretion of either the site investigator or the sponsor
Pregnant or lactating women
You have been diagnosed with bipolar disorder, dementia, schizophrenia, or any other serious mental illness.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Titration
Participants undergo a 4-week titration phase to achieve a target steady-state dose of ecopipam
4 weeks
Weekly visits for dose adjustment
Treatment
Participants receive maintenance dose of ecopipam and are evaluated for safety
24 months
Monthly visits (in-person) at Months 1-12, 15, 18, 21, and 24
Follow-up
Participants are monitored for safety after the last dose of ecopipam
1 month
2 visits (in-person) at 7 and 14 days, 1 follow-up phone call at 30 days
Treatment Details
Interventions
- Ecopipam (Other)
Trial OverviewThe study tests the long-term safety of ecopipam tablets in treating Tourette's Syndrome across various age groups. It aims to understand how well patients tolerate this medication over an extended period.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Ecopipam 1.8 mg/kg/dayExperimental Treatment1 Intervention
Ecopipam tablets will be administered orally (PO) once daily in the evening without regard to meals at concentrations 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 milligrams (mg) containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively in 4-week titration phase to achieve a target dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day ecopipam HCl). Participants will be evaluated for safety at each baseline visit and at all treatment visits up to 24 months and at follow up visits at 7 and 14 days after last dose of ecopipam.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rush University Medical CenterChicago, IL
Yale School of MedicineNew Haven, CT
Research in Miami IncHialeah, FL
Michigan Clinical research Institute PCAnn Arbor, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Emalex Biosciences Inc.Lead Sponsor
References
Ecopipam for Tourette Syndrome: A Randomized Trial. [2023]All US Food and Drug Administration-approved medications for Tourette syndrome are antipsychotics, and their use is limited by the risk of weight gain, metabolic changes, and drug-induced movement disorders. Several small trials suggest that ecopipam, a first-in-class, selective dopamine 1 receptor antagonist, reduces tics with a low risk for these adverse events. This trial sought to further evaluate the efficacy, safety, and tolerability of ecopipam in children and adolescents with moderate to severe Tourette syndrome.
A D1 receptor antagonist, ecopipam, for treatment of tics in Tourette syndrome. [2021]Dysregulation of dopaminergic signaling has been hypothesized to underlie the motor and phonic tics in Tourette syndrome (TS). The objective of this trial was to evaluate the safety and tic-reducing activity of the selective dopamine D1 receptor antagonist ecopipam in adults with TS.
Ecopipam, a D1 receptor antagonist, for treatment of tourette syndrome in children: A randomized, placebo-controlled crossover study. [2019]Dopamine D2 receptor antagonists used to treat Tourette syndrome may have inadequate responses or intolerable side effects. We present results of a 4-week randomized, double-blind, placebo-controlled crossover study evaluating the safety, tolerability, and efficacy of the D1 receptor antagonist ecopipam in children and adolescents with Tourette syndrome.
Future therapies of Tourette syndrome. [2019]Currently available pharmacologic therapies for Tourette syndrome often are characterized by limited effectiveness and unacceptable side effect profiles. In recent years, however, a series of new approaches have emerged which may lead to novel, more effective, and better tolerated treatments of tics and associated behavioral problems. Especially promising is the wide range of new atypical antipsychotic medications with unique and diverse receptor affinity profiles that are entering clinical practice. Over the next few years, intensive research efforts will be required to characterize the effect of the new atypical antipsychotics in patients with Tourette syndrome and related disorders, and to determine which sets of symptoms and which subgroups of patients best respond to particular agents. In the near future, corticotropin-releasing factor antagonists and agents which act on excitatory amino acid neurotransmitter systems also will become available and may provide treatment interventions, which theoretically could alter the long term course and outcome of Tourette syndrome. In addition, nonpharmacologic interventions, such as immunologic and behavior therapies, are receiving increasing attention and may provide an alternative or supplement to medication for selected subgroups of Tourette syndrome patients.
[The benzamides tiapride, sulpiride, and amisulpride in treatment for Tourette's syndrome]. [2018]The treatment of Tourette's syndrome is a challenge. Dopamine receptor antagonists are the drugs of first choice for the treatment of tics. Because large controlled trials are lacking, there is no consensus about which of the different neuroleptic drugs should be preferred. In Germany, tiapride seems to be used most often for the treatment of tics in children - although only one small controlled trial has been performed on it till now. In adults, other dopamine receptor antagonists such as risperidone, pimozide, and sulpiride seem to be more effective than tiapride. Today it is unknown whether new atypical neuroleptic drugs including the benzamide amisulpride are more effective than the older benzamides tiapride and sulpiride.
Treatment of phonic tics in patients with Tourette's syndrome using botulinum toxin type A. [2010]We assessed the effect of botulinum toxin type A (BTX-A) on phonic tics in patients with Tourette's syndrome. A total of 30 patients received 2.5 IU BTX-A (BOTOX; Allergan) in both vocal cords. All patients were assessed after 15 days and then 4 times over a 12-month period. At each visit the following data were collected: phenomenology of tics, global impression of changes by physician and patient, number of BTX-A injections given, interval between injections, time to response, duration of response, presence of post-injection hypophonia and side effects, presence of premonitory sensory tic component, and interference with social life and work or school activities. Vocal tics improved after treatment in 93% patients, with 50% being tic-free. Mean response time was 5.8 days, and mean duration of response was 102 days. Quality of life improved, and premonitory experiences dropped from 53% to 20%. Hypophonia was the only side effect of note (80% of patients). BTX-A is an effective and safe treatment for phonic tics associated with Tourette's syndrome.