EpilepsyPhase 3NCT02161185

A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters

A Phase 3 study testing USL261 in people with Epilepsy, run by UCB Biopharma S.P.R.L. at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters. Read more about this study

Who is it for?: Ages 12 to 65 years
Conditions the study is for: Epilepsy
What is being tested?: USL261
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 16 sitesUnited States
Study dates: May 2014to May 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes
Has an established diagnosis of partial or generalized epilepsy that includes all the following:
A documented history of seizure clusters lasting a minimum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
A second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition
A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures
A seizure cluster pattern established >3 months before Visit 1

Show all 10Show fewer

A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1
At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1
Currently on a stable regimen of AED(s) that includes a benzodiazepine
Weight is 40 kg to 125 kg, inclusive

Who cannot join

Has a neurological disorder that is likely to progress in the next year
Has a severe chronic cardio-respiratory disease
Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1
Has a history of acute narrow-angle glaucoma
Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Study site
Aurora, Colorado
Study site
Boise, Idaho
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Fresno, California
Study site
Houston, Texas
Study site
Lexington, Kentucky
Study site
Nashville, Tennessee
Study site
Philadelphia, Pennsylvania
Study site
Port Charlotte, Florida
Study site
Reno, Nevada
Study site
Saint Paul, Minnesota
Study site
San Antonio, Texas
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Ventura, California

Other trials in United States

About this study

Official title: An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

Conditions: Epilepsy
Being tested: USL261
Keywords: Epilepsy, seizure cluster, acute repetitive seizures, open-label, intranasal Midazolam, USL261, Upsher-Smith
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

USL261Drug
Also called Intranasal Midazolam
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol

Study groups in NCT02161185
Study group	Role	What they receive
USL261	Other	Not described Receives: Drug: USL261

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study
Measured: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.

Secondary outcomes (1)

Treatment Success
Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration. Due to early termination of the study, this data was not analyzed.
Measured: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014May 2015

First posted11 Jun 2014 (estimated)
Study startMay 2014
Primary completionMay 2015
Study completionMay 2015

Why it stopped: Study terminated due to slow enrollment. There were no safety concerns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02161185
Sponsor's protocol ID: P261-408
Other IDs: 2014-001604-22, 2014
Status last verified: Oct 2019
First submitted: 9 Jun 2014
Last updated: 10 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters
ClinicalTrials.gov ID: NCT02161185
Acronym / sponsor ID: P261-408
Conditions: Epilepsy
Keywords: Epilepsy, seizure cluster, acute repetitive seizures, open-label, intranasal Midazolam, USL261, Upsher-Smith
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated due to slow enrollment. There were no safety concerns.
Enrolment: 7 participants (actual)
Lead sponsor: UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
Study start: May 2014
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 11 Jun 2014 (estimated)
Results: Posted 14 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
USL261	Other	Drug: USL261

Who may qualify

Ages: 12 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes
Has an established diagnosis of partial or generalized epilepsy that includes all the following:
Currently on a stable regimen of AED(s) that includes a benzodiazepine
Weight is 40 kg to 125 kg, inclusive

Key exclusion criteria (6 listed)

Has a neurological disorder that is likely to progress in the next year
Has a severe chronic cardio-respiratory disease
Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1
Has a history of acute narrow-angle glaucoma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
USL261Also: Intranasal Midazolam5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol	Drug	USL261

Primary outcome

Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
Time frame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study

1 secondary outcome

Treatment Success
Time frame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.

Results and safety

Results posted to the registry on 14 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
USL261	7	7

Primary outcome: Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation

Time frame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.. Count of participants. Unit: Participants

Measure	USL261 n = 7
Value	0

Population analysed: Participants who received at least one dose of study drug

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
USL261	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7

Limitations and caveats (from the sponsor): Early termination due to poor enrollment leading to small numbers of subjects analyzed for safety. Efficacy was not analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

TzeChiang Meng, MD study director

Proximagen, LLC

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing USL261 in people with Epilepsy, run by UCB Biopharma S.P.R.L. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation (time frame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02161185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.