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Dopamine D1 Antagonist

200 mg ecopipam HCL for Long QT Syndrome

Phase 1
Waitlist Available
Research Sponsored by Emalex Biosciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female of nonchildbearing potential
18 to 55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 33
Awards & highlights

Study Summary

This trial tested a drug to see how it affects the heart's electrical activity and its ability to pump blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 33
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 33 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate ecopipam's effect on the QTc interval after administration of therapeutic and supratherapeutic doses, compared to placebo as a negative control using C-QTc analysis.
Secondary outcome measures
Describe the AUCext of EBS-101-40853 after single supratherapeutic dose of ecopipam
Describe the AUCext of EBS-101-40853 after single therapeutic dose of ecopipam
Describe the AUCext of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam
+75 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 600 mg ecopipam HCLExperimental Treatment1 Intervention
Single 600 mg dose of ecopipam HCL given as 6 x 100 mg ecopipam HCL oral tablets
Group II: 200 mg ecopipam HCLExperimental Treatment2 Interventions
Single 200 mg dose of ecopipam HCL given as 2 x 100 mg ecopipam HCL oral tablets and 4 placebo oral tablets
Group III: 400 mg moxifloxacinActive Control1 Intervention
Single 400 mg dose of moxifloxacin given as 1 x 400 mg oral tablet
Group IV: PlaceboPlacebo Group1 Intervention
Single oral dose of 6 x placebo tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ecopipam Hydrochloride
2023
Completed Phase 1
~30
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Emalex Biosciences Inc.Lead Sponsor
10 Previous Clinical Trials
863 Total Patients Enrolled
PPDIndustry Sponsor
158 Previous Clinical Trials
36,754 Total Patients Enrolled
ClarioUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor recruiting individuals older than 45 years of age?

"The criteria for participation in this medical trial includes being under 55 years and over 18."

Answered by AI

Has the FDA sanctioned ecopipam HCL at a dosage of 200 mg?

"Due to the limited data on safety and efficacy, our team has assigned a score of 1 for 200 mg ecopipam HCL. This is in accordance with its Phase 1 classification."

Answered by AI

Does this experiment have a current recruitment period for participants?

"Affirmative, the information hosted on clinicaltrials.gov elucidates that enrollment is open for this medical experiment which was initially published on March 15th 2023 and subsequently altered on April 21st 2023. The investigation seeks to recruit 32 individuals from a single location."

Answered by AI

How many subjects are participating in the current clinical investigation?

"That is correct. Per the public record hosted on clinicaltrials.gov, this medical trial has been open since March 15th 2023 and it still recruiting patients today. Approximately 32 people are needed to be enrolled from a single research centre."

Answered by AI

What prerequisites must be fulfilled in order to join this clinical trial?

"Prospective participants for this medical trial must have long qt syndrome, with an age range between 18 and 55. 32 individuals are currently being sought after to enroll in the study."

Answered by AI
~14 spots leftby Mar 2025