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TAK-935 for Epilepsy (ELEKTRA Trial)

Phase 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; treatment period: weeks 0 to 20

Summary

The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.

Eligible Conditions

Epilepsy
Lennox Gastaut Syndrome
Dravet Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; treatment period: weeks 0 to 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; treatment period: weeks 0 to 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; treatment period: weeks 0 to 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period

Secondary study objectives

Change From Baseline in Clinician's Clinical Global Impression of Severity (CGI-S) Responses of Investigator Reported Impression of Efficacy and Tolerability of Study Drug

Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy

Change From Baseline in Seizure Frequency in Participants Treated With TAK-935 as an Adjunctive Therapy

+7 more

Side effects data

From 2018 Phase 1 & 2 trial • 18 Patients • NCT03166215

21%

Dysarthria

14%

Upper respiratory tract infection

14%

Lethargy

14%

Headache

14%

Fatigue

Sinusitis

Seizure Cluster

Agitation

Irritability

Rhinitis

Tic

Balance disorder

Repetitive speech

Somnolence

Burning sensation

Diarrhoea

Nausea

Arthralgia

Urinary incontinence

Gait disturbance

Vomiting

Pyrexia

Asthenia

Peripheral swelling

Fall

Eye contusion

Human bite

Skin abrasion

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: TAK-935

Part 2: TAK-935

Part 1: Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TAK-935Experimental Treatment1 Intervention

TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing \<60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.

Group II: PlaceboPlacebo Group1 Intervention

TAK-935 placebo-matching tablets, orally or via gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG), twice a day (BID) up to Week 20.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-935

2020

Completed Phase 2

~300

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