Ecopipam for Tourette Syndrome

(D1AMOND Trial)

No longer recruiting at 69 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Emalex Biosciences Inc.

Must not be taking: Certain medications

Disqualifiers: Dementia, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of ecopipam tablets for treating Tourette Syndrome in children and teenagers. Tourette Syndrome causes involuntary movements and sounds, known as tics. The trial targets those who completed a previous study with ecopipam and might benefit from continued treatment. Individuals with certain mood disorders or unstable medical conditions may not qualify. Participants will continue taking ecopipam to assess its safety for long-term use. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not clearly state if you need to stop your current medications, but it mentions that certain medications causing drug interactions are excluded. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ecopipam is likely to be safe for humans?

Research has shown that ecopipam, the treatment under study, is generally well-tolerated. Studies have found that ecopipam works effectively and may be safer than other drugs that block D2 receptors, often used for similar conditions. This suggests it might cause fewer side effects than some other treatments.

In earlier trials, patients taking ecopipam experienced few serious side effects, indicating it is safe for most people. However, individual reactions can vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Tourette Syndrome?

Ecopipam is unique because it takes a different approach to treating Tourette Syndrome in children and adolescents. Unlike standard treatments like antipsychotics and alpha agonists, which primarily focus on managing symptoms by altering neurotransmitter levels broadly, Ecopipam targets the dopamine D1 receptor specifically. This new mechanism of action could mean fewer side effects and a more targeted therapy, offering hope for better management of Tourette's symptoms. Researchers are excited about Ecopipam because it represents a novel pathway for treatment that could improve quality of life for young patients without the drawbacks associated with current medications.

What evidence suggests that ecopipam might be an effective treatment for Tourette Syndrome?

Research has shown that ecopipam, the treatment under study in this trial, can help reduce tics in people with Tourette Syndrome. Studies have found that ecopipam, which blocks certain chemicals in the brain, is generally safe and well-tolerated. Early results suggest it lessens the severity of tics, which are sudden, repetitive movements or sounds. Overall, ecopipam appears promising for managing symptoms in children and teens with Tourette Syndrome. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up Visit within the last 30 days (or longer with permission of the medical monitor) without a major reportable protocol deviation and must be someone the Investigator feels would benefit from continued participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ecopipam tablets titrated to a target dose of 2 mg/kg/day

12 months

Monthly visits for 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person), 1 follow-up phone call

What Are the Treatments Tested in This Trial?

Interventions

• Ecopipam

How Is the Trial Designed?

Group I: Ecopipam Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Emalex Biosciences Inc.

Lead Sponsor

Trials

16

Recruited

1,000+

Published Research Related to This Trial

Oxybutynin chloride is effective in managing conditions like neurovesical dysfunction, enuresis, and bladder spasms due to its anticholinergic and muscle relaxant properties, as shown in controlled clinical studies.

The drug's synergistic effects on both the nervous system and muscle relaxation make it a valuable treatment option for patients with uninhibited bladders and primary muscle spasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxybutynin in bladder spasm, neurogenic bladder, and enuresis. Thompson, IM., Lauvetz, R.[2019]

In a study of 84 children aged 30 months to 15 years taking oxybutynin chloride (Ditropan), 52 experienced atropinic symptoms, indicating a high incidence of side effects, particularly in younger patients.

The frequency of side effects was found to be four times higher in children compared to adults, suggesting that dosage and metabolic differences may contribute to this increased risk, leading to new recommendations for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse effects of oxybutynin chloride (Ditropan) in pediatrics]. Jonville, AP., Dutertre, JP., Barbellion, M., et al.[2013]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/91/NCT04007991/Prot_000.pdf

ECOPIPAM (EBS-101) EBS-101-CL-001 Additional safety outcomes (Baseline and Weeks 4, 6, 8 and 12) will include the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Rating Scale ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05615220

Ecopipam Tablets to Study Tourette's Disorder in Children ... This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the ...

3. en.wikipedia.org en.wikipedia.org/wiki/Ecopipam

Ecopipam Ecopipam is a dopamine antagonist which is under development for the treatment of Lesch–Nyhan syndrome, Tourette syndrome, speech disorders, and restless ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1096719216300178

A clinical trial of safety and tolerability for the selective ... The D1R antagonist in this study SCH 39166 (ecopipam) has been assessed in several clinical studies and has been shown to be well tolerated and effective in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39730854/

Safety and Efficacy of Ecopipam in Patients with Tourette ... Ecopipam is effective in reducing the severity of tics in subjects with TS and has a good safety profile. However, only a limited number of ...

6. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-14689/Ecopipam-hydrochloride-SDS-MedChemExpress.pdf

Ecopipam hydrochloride-SDS-MedChemExpress Use full personal protective equipment. Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. www.

7. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/170317

Ecopipam Hydrochloride | C19H21Cl2NO - PubChem - NIH Primary Hazards. Irritant. Laboratory Chemical Safety Summary (LCSS) Datasheet ; Molecular Formula. C19H21Cl2NO ; Synonyms. Ecopipam hydrochloride; 190133-94-9 ...

8. medchemexpress.com medchemexpress.com/ecopipam-hydrochloride.html?srsltid=AfmBOooeicdqCDbkeYkYsuDKLK9W_GDEABB0saP5QbnggjffxlGXty81

Ecopipam hydrochloride (Synonyms: SCH 39166 ... Ecopipam (SCH 39166) hydrochloride is a potent, selective and orally active antagonist of dopamine D1/D5 receptor, with Kis of 1.2 nM and 2.0 nM, respectively.