Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension

(D1AMOND Trial)

Recruiting at 64 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

124 Participants Needed

Trial Summary

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.

What makes the drug Ecopipam unique compared to other treatments?

Ecopipam is unique because it works by blocking dopamine D1 receptors, which is different from many other treatments that target different pathways. This mechanism may offer a novel approach for conditions where dopamine plays a key role. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tested the safety of ecopipam tablets for children and adolescents with Tourette Syndrome. The medication aims to help manage their symptoms by affecting brain chemicals. Participants took the medication for an extended period with frequent check-ups. Ecopipam has shown promise in previous studies.

Eligibility Criteria

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

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

Treatment Details

Interventions

• Ecopipam

Participant Groups

Group I: Ecopipam Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Emalex Biosciences Inc.

Lead Sponsor

Trials

16

Recruited

1,000+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

BP-294 Ste Civile Bioprojet. [2005]

2. France pubmed.ncbi.nlm.nih.gov

[Adverse effects of oxybutynin chloride (Ditropan) in pediatrics]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacological profile of CEB-1957 and atropine toward brain muscarinic receptors and comparative study of their efficacy against sarin poisoning. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Oxybutynin in bladder spasm, neurogenic bladder, and enuresis. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Injectable, Adhesive, and Self-Healing Composite Hydrogels Loaded With Oxybutynin Hydrochloride for the Treatment of Overactive Bladder in Rats. [2022]