Infantile SpasmsPhase 4NCT01413711

An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms

A Phase 4 study testing Vigabatrin in people with Infantile Spasms, run by Lundbeck LLC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin. Read more about this study

Who is it for?: Ages 1 month to 6 months
Conditions the study is for: Infantile Spasms
What is being tested?: Vigabatrin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Jun 2012to Sep 2013
Phase: Phase 4
Are there results?: None posted in the registry

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 1 month to 6 months
All sexes
No healthy volunteers
Child

Who may be able to join

The patient's parent or legally authorized representative is able to read and understand the Patient Information Sheet and Informed Consent Form.
The patient's legally authorized representative has signed the Informed Consent Form.
The patient has IS, diagnosed according to the International League Against Epilepsy (ILAE) criteria.
The patient is a full term (38 weeks gestation) male or female, aged >=1 month to <6 months at the time of enrollment.
The patient's length and body weight for gestational age is >=5th and <=95th percentile, according to Centers for Disease Control and Prevention (CDC) Growth Charts.

Who cannot join

The patient is currently being treated or has been previously treated with vigabatrin.
The patient is a member of the site personnel's immediate family.
The patient takes or has taken disallowed recent or concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to the investigational medicinal product (IMP) or the excipients (povodone/iodine) of the IMP.
The patient has any other disorder for which the treatment takes priority over treatment of IS or is likely to interfere with study treatment or impair treatment compliance.
The patient has been treated with any IMP within 30 days or 5 half lives (whichever is longer) prior to the Screening Visit.

Show all 10Show fewer

The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
The patient has been diagnosed or is judged by the investigator to have anemia.
The patient has been diagnosed or is judged by the investigator to have renal insufficiency.
The patient's parent or legally authorized representative is, in the investigator's opinion, unlikely or unwilling to comply with the protocol or the patient is unsuitable for any reason.

About this study

The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin.

Conditions: Infantile Spasms
Being tested: Vigabatrin
Keywords: IS, Pharmacokinetics, Area under the curve, Maximum plasma concentration, Time to maximum concentration
Medical subject headings: Spasms, Infantile

What participants receive

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

VigabatrinDrug
Also called Sabril®
Oral vigabatrin as a single 25 mg/kg dose on Days 1 and 5, 25 mg/kg twice a day (50 mg/kg daily dose, orally) on Days 2-4

Study groups in NCT01413711
Study group	Role	What they receive
Vigabatrin	Experimental	Not described Receives: Drug: Vigabatrin

What is being measured

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

Non-compartmental pharmacokinetic profile of vigabatrin after oral administrations in infants(>=1 and <6 months of age)
Serial blood for plasma generation will be collected on Days 1 and 5 and vigabatrin concenrations determined to the determine the pharmacokinetic profile of vigabatrin
Measured: 24 hrs post dose on Day 1 and 12 hrs post dose on Day 5

Secondary outcomes (1)

To determine the safety of vigabatrin following oral dose administrations in infants (>=1 and <6 months of age)
Safety and tolerability parameters such as adverse events, clinical safety laboratory tests and vital signs will be summarised using descriptive statistics
Measured: Safety collected throughout the 5-day study

Timeline

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

Jun 2012Sep 2013

First posted10 Aug 2011 (estimated)
Study startJun 2012
Primary completionSep 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infantile SpasmsStudies 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 4
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01413711
Sponsor's protocol ID: 13453A
Status last verified: Sep 2012
First submitted: 17 Jun 2011
Last updated: 13 Sep 2012
Results posted: No
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?

Official record

Not yet recruitingObservational study
IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).
Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy
Active, not recruitingPhase 3
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure
RecruitingPhase 2
Treatment of Refractory Infantile Spasms With Fenfluramine
Infantile Spasm
RecruitingObservational study
Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents
Epilepsy, West Syndrome
RecruitingPhase 2
A Study to Prevent Infantile Spasms Relapse
Infantile Spasms, Infantile Epileptic Spasms Syndrome

All Infantile Spasms trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
ClinicalTrials.gov ID: NCT01413711
Acronym / sponsor ID: 13453A
Conditions: Infantile Spasms
Keywords: IS, Pharmacokinetics, Area under the curve, Maximum plasma concentration, Time to maximum concentration
Phase: Phase 4
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Lundbeck LLCIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Sep 2013 (estimated)
First posted: 10 Aug 2011 (estimated)
Results: Not posted in the source record

Clinical summary

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

The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin.

Study design

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

Arm	Type	Receives
Vigabatrin	Experimental	Drug: Vigabatrin

Who may qualify

Ages: 1 month to 6 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

The patient's parent or legally authorized representative is able to read and understand the Patient Information Sheet and Informed Consent Form.
The patient's legally authorized representative has signed the Informed Consent Form.
The patient has IS, diagnosed according to the International League Against Epilepsy (ILAE) criteria.
The patient is a full term (38 weeks gestation) male or female, aged >=1 month to <6 months at the time of enrollment.
The patient's length and body weight for gestational age is >=5th and <=95th percentile, according to Centers for Disease Control and Prevention (CDC) Growth Charts.

Key exclusion criteria (10 listed)

The patient is currently being treated or has been previously treated with vigabatrin.
The patient is a member of the site personnel's immediate family.
The patient takes or has taken disallowed recent or concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to the investigational medicinal product (IMP) or the excipients (povodone/iodine) of the IMP.
The patient has any other disorder for which the treatment takes priority over treatment of IS or is likely to interfere with study treatment or impair treatment compliance.

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
VigabatrinAlso: Sabril®Oral vigabatrin as a single 25 mg/kg dose on Days 1 and 5, 25 mg/kg twice a day (50 mg/kg daily dose, orally) on Days 2-4	Drug	Vigabatrin

Primary outcome

Non-compartmental pharmacokinetic profile of vigabatrin after oral administrations in infants(>=1 and <6 months of age)
Time frame: 24 hrs post dose on Day 1 and 12 hrs post dose on Day 5
Serial blood for plasma generation will be collected on Days 1 and 5 and vigabatrin concenrations determined to the determine the pharmacokinetic profile of vigabatrin

1 secondary outcome

To determine the safety of vigabatrin following oral dose administrations in infants (>=1 and <6 months of age)
Time frame: Safety collected throughout the 5-day study

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.

Related trials for Infantile Spasms

Not yet recruitingObservational study
IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).
Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy
Active, not recruitingPhase 3
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure
RecruitingPhase 2
Treatment of Refractory Infantile Spasms With Fenfluramine
Infantile Spasm
RecruitingObservational study
Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents
Epilepsy, West Syndrome
RecruitingPhase 2
A Study to Prevent Infantile Spasms Relapse
Infantile Spasms, Infantile Epileptic Spasms Syndrome

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.

Email contact via H. Lundbeck A/S study director

LundbeckClinicalTrials@lundbeck.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vigabatrin in people with Infantile Spasms, run by Lundbeck LLC.

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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Non-compartmental pharmacokinetic profile of vigabatrin after oral administrations in infants(>=1 and <6 months of age) (time frame: 24 hrs post dose on Day 1 and 12 hrs post dose on Day 5). 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 NCT01413711.

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 13 Sep 2012.