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New drug candidate aims to calm restless legs when current meds backfire

NCT ID NCT03218969

Symptom relief Sponsor: William Ondo, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small study tested whether ecopipam, a drug that blocks a specific brain receptor, can help people with restless leg syndrome whose symptoms have gotten worse from their usual dopamine-based medication. Ten adults took either ecopipam or a placebo for six weeks, then switched after a two-week break. Researchers measured changes in symptom severity and how much of the body was affected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ecopipam (a D1 receptor antagonist, taken orally)
What this could lead to
If it works, this could offer a new way to manage RLS when standard treatments stop working or make symptoms worse.
What could go wrong
This is a very small, early-phase trial with only 10 people. Results may not apply to everyone, and the drug may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

10 people

The number who actually took part.

Started

Sep 2017

Finished

Nov 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Provide consent to participate in the study * Individuals of either sex, 21-80 years of age * Clinically defined Restless Leg Syndrome, and problematic augmentation currently on monotherapy with dopaminergic treatment. Exclusion Criteria: * Current use of Opioid medications * Clinical relevant depression or other medical problems that in the opinion of the investigator would not allow for safe completion of the protocol. * Suicidal ideation * History of epilepsy * Current MAO inhibitors

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Conditions

The condition(s) this trial relates to.

restless legs syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Augmentation Restless legs syndrome

Contacts and locations

Locations

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.