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Could a seizure drug fix lazy eye in teens?

NCT ID NCT07226141

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This early-stage trial tests whether adding the drug valproate to standard patching therapy can improve vision in children aged 8 to 17 with lazy eye (amblyopia). Participants will take valproate or a placebo daily for 8 weeks while patching the stronger eye. The study aims to see if valproate helps the weaker eye see better and whether any improvement lasts.

What this could mean

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

Active substance
valproate (an anti-epileptic drug)
What this could lead to
If it works, this could offer a new way to improve vision in older children with lazy eye who haven't responded to standard treatment alone.
What could go wrong
This is an early phase 1/2 trial with only 28 participants, so results may not apply widely. Valproate can cause side effects like drowsiness or liver issues, and the vision improvement may be small or temporary.

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

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

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

8 to 17 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: 1. Age 8-17 years 2. Amblyopia associated with strabismus and/or anisometropia * Criteria for strabismus: must meet at least one of the following: * Heterotropia at distance and/or near with or without spectacle correction * History of strabismus surgery * Documented history of strabismus that is no longer present and felt by the investigator could have caused the amblyopia * Criteria for anisometropia: must meet at least one of the following: * ≥ 0.50 D difference in spherical equivalent between eyes * ≥ 1.50 D difference in astigmatism in any meridian between the eyes 3. Visual acuity measured in each eye within 7 days prior to enrollment using ETDRS protocol on a study certified visual acuity tester as follows: * Amblyopic eye visual acuity of 20/40 - 20/400 * Sound eye acuity of ≥ 20/25. 4. Current amblyopia treatment (other than spectacle correction) * Subjects actively patching at the time of enrollment screening should continue patching through enrollment * Visual acuity in amblyopic eye has not improved ≥ 1 line (5 letters) by the same testing method from a previous visit ≥ 8 weeks earlier while on treatment * Since this determination is a pre-study examination, the method of visual acuity testing is not mandated * Atropine treatment at any time during this pre-enrollment period is not allowed * Any treatment prior to the current patching episode with stable acuity is allowed 5. Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction \< 6 months old: • Requirement for spectacle correction: * Spherical equivalent must be within 0.50 D of fully correcting anisometropia * Hyperopia ≥ 3.00 D must be corrected * Hyperopia may not be undercorrected by \> 1.50 D spherical equivalent and must be symmetrically reduced in each eye * Cylinder power must be within 0.50 D of fully correcting the astigmatism * Cylinder axis must be within 6 degrees of the axis in the spectacles when the cylinder power is ≥ 1.00 D * Myopia of the amblyopic eye \> 0.50 D spherical equivalent must be corrected ◊ Myopia may not be undercorrected by \> 0.25 D or overcorrected by \> 0.50D • Spectacles meeting the above criteria must be worn: * Until visual acuity in amblyopic eye has not improved ≥ 1 line (5 letters) by the same testing method during 2 consecutive visual acuity measurements at least 4 weeks apart (i.e. minimum of 8 weeks spectacle correction) ◊ Since this determination is a pre-study examination, the method of visual acuity testing is not mandated 6. Eye examination within 6 months prior to enrollment 7. Subject must be available for at least 6 months of follow-up, have access to a phone, and be willing to be contacted by clinical staff 8. By investigator judgment, the subject is likely to comply with prescribed treatment (i.e. no prior history of poor compliance with patching) and unlikely to continue to improve with 2 hours of daily patching alone 2.2.2 Exclusions 1. Myopia \> -6.00 D spherical equivalent 2. Presence of associated findings that could cause reduced visual acuity • Nystagmus does not exclude the subject if the above visual acuity criteria are met 3. Previous intraocular or refractive surgery 4. Strabismus surgery planned within 16 weeks 5. Current vision therapy or orthoptics 6. Known past or present liver or kidney disease 7. Known past or present mitochondrial/metabolic disorder 8. Known past or present psychological problems 9. Known allergies or contraindications to the use of valproate or anti-epileptic medication 10. Current use of medication for the treatment of seizures, bipolar disorder, or migraine, or any medication on the appended list of medications that interact with valproate/valproate acid and its derivatives which can be found here. 11. Prior valproate use 12. Known skin reaction to patch or bandage adhesives 13. Treatment with topical atropine within the past 12 weeks 14. Individuals capable of pregnancy who are pregnant, lactating, or may become pregnant within the next 6 months * A negative urine pregnancy test will be required for all participants who have experienced menarche at the time of enrollment * Individuals capable of pregnancy must convey an active suitable plan to avoid pregnancy that includes at least one of the following: * Hormonal Contraceptives: * Combined oral contraceptives (the pill) * Contraceptive patch * Vaginal contraceptive ring * Progestin-only pills * Hormonal injections (e.g., Depo-Provera) * Hormonal implants (e.g., Nexplanon) * Intrauterine Devices (IUDs): * Copper IUD (e.g., ParaGard) * Hormonal IUDs (e.g., Mirena, Skyla, Liletta) * Barrier Methods with Spermicide (less commonly used alone but may be used in combination with other methods for added protection): * Male condoms * Female condoms * Diaphragms with spermicide * Cervical caps with spermicide * Sterilization: * Tubal ligation (for females) * Vasectomy (Having a partner who has undergone a vasectomy, confirmed by semen analysis) * Abstinence or True Sexual Abstinence: o Refraining from heterosexual intercourse * Requirements regarding the establishment of pregnancy status and monitoring for pregnancy over the course of the study may be further defined by the IRB

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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