Adult Refractory Complex Partial SeizuresPhase 4NCT01278173

A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)

A Phase 4 study testing Sabril in people with Adult Refractory Complex Partial Seizures, run by Lundbeck LLC at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the change in visual fields by means of automated static perimetry and to evaluate the change in retinal structure by means of spectral domain optical coherence tomography (SD-OCT) in adult patients with refractory complex partial seizures (CPS) being treated with vigabatrin… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Adult Refractory Complex Partial Seizures
What is being tested?: Sabril
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 22 sitesUnited States
Study dates: Dec 2010to May 2015
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Prior exposure to Sabril.
Pre-existing ocular or neurological disease that might affect bilateral visual fields or interfere with perimetry (e.g., aphakia, visually significant cataract, glaucoma, diabetes mellitus, ischemic optic neuropathy, multiple sclerosis). Patients with stable visual field defects from CNS lesions (e.g., epilepsy surgery more than 6 months prior to receiving Sabril) may be enrolled.
Concurrent exposure to medications with known or suspected retinal or optic nerve toxicity.
Concurrent use of an investigational agent or device or such use within 30 days of entering the study.
Concurrent use of the ketogenic or similar diet.
For any reason, the patient is considered by the investigator to be an unsuitable candidate for the study.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Peachtree Neurological Clinic
Atlanta, Georgia, 30309
Idaho Comprehensive Epilepsy Center
Boise, Idaho, 83702
Medical University of South Carolina
Charleston, South Carolina, 29425
Neuroscience & Spine Institute
Charlotte, North Carolina, 28207
CNMRI
Dover, Delaware, 19901
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54308
Sunrise Clinical Research Group
Hollywood, Florida, 33021-2834
University of Texas
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky Lexington
Lexington, Kentucky, 40536
Covenant Medical Group
Lubbock, Texas, 79410
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Yale Medical Center
New Haven, Connecticut, 06520
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Columbia University Medical Center
New York, New York, 10087
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University
Portland, Oregon, 97239
Minnesota Epilepsy Group, PA
Saint Paul, Minnesota, 55102
University of Texas Health Science Center
San Antonio, Texas, 78229
California Pacific Medical Center
San Francisco, California, 94115
University of South Florida
Tampa, Florida, 33606

Other trials in United States

About this study

Official title: A Prospective, Open-label Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)

Read the detailed description

Multicenter, prospective open-label study with approximately 25 sites in the US that specialize in caring for adult patients with refractory CPS

Sites must have access to Humphrey static perimetry and to Spectralis SD-OCT.
All vision test results will be sent to the central readers for evaluation.
Additional study tests:
The Columbia Suicide Severity Rating Scale (C-SSRS)
The National Eye Institute Visual Field Questionnaire-39 (NEI VFQ-39)
A whole blood sample for specific analysis of DNA characteristics
An optional whole blood sample for exploratory analysis of DNA characteristics
Plasma samples for bioanalytical analysis of vigabatrin and blood samples for taurine biomarker analysis

Conditions: Adult Refractory Complex Partial Seizures
Being tested: Sabril
Keywords: Vigabatrin-associated vision change, Adult refractory complex partial seizures, CPS, Epilepsy, Seizures, Brain diseases, Central Nervous System Diseases, Nervous System Diseases, Neurologic Manifestations, Enzyme Inhibitors, GABA Agents
Medical subject headings: Seizures, Epilepsy, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurologic Manifestations

What participants receive

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

SabrilDrug
Also called Vigabatrin
Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.

Study groups in NCT01278173
Study group	Role	What they receive
Sabril	Other	Not described Receives: Drug: Sabril

What is being measured

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

Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)
Mean change from the reference value in 30-2 SITA mean deviation, which was generated using the University of Iowa Visual Field Reading Center (VFRC) normative database and the Humphrey Field Analyzer (HFA) normative database. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). The mean change from the reference value are presented for Months 3, 6, 9 and 12. A negative change from the reference value indicates a decrease in the central visual field.
Measured: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography)
Mean change from the reference value in average RNFL thickness (µm) as measured by SD-OCT. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). Thinning of the RNFL, that is, a negative change from the reference value, has been associated with ophthalmological disease.
Measured: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12

Timeline

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

Dec 2010May 2015

First posted17 Jan 2011 (estimated)
Study startDec 2010
Primary completionMay 2015
Study completionMay 2015

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 Adult Refractory Complex Partial SeizuresStudies 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
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01278173
Sponsor's protocol ID: 13098A
Status last verified: Apr 2016
First submitted: 14 Jan 2011
Last updated: 7 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open-label Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
ClinicalTrials.gov ID: NCT01278173
Acronym / sponsor ID: 13098A
Conditions: Adult Refractory Complex Partial Seizures
Keywords: Vigabatrin-associated vision change, Adult refractory complex partial seizures, CPS, Epilepsy, Seizures, Brain diseases, Central Nervous System Diseases, Nervous System Diseases
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Lundbeck LLCIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 17 Jan 2011 (estimated)
Results: Posted 7 Jun 2016

Clinical summary

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

Detailed description

Multicenter, prospective open-label study with approximately 25 sites in the US that specialize in caring for adult patients with refractory CPS

Sites must have access to Humphrey static perimetry and to Spectralis SD-OCT.
All vision test results will be sent to the central readers for evaluation.
Additional study tests:
The Columbia Suicide Severity Rating Scale (C-SSRS)
The National Eye Institute Visual Field Questionnaire-39 (NEI VFQ-39)
A whole blood sample for specific analysis of DNA characteristics
An optional whole blood sample for exploratory analysis of DNA characteristics
Plasma samples for bioanalytical analysis of vigabatrin and blood samples for taurine biomarker analysis

Study design

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

Arm	Type	Receives
Sabril	Other	Drug: Sabril

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (6 listed)

Prior exposure to Sabril.
Pre-existing ocular or neurological disease that might affect bilateral visual fields or interfere with perimetry (e.g., aphakia, visually significant cataract, glaucoma, diabetes mellitus, ischemic optic neuropathy, multiple sclerosis). Patients with stable visual field defects from CNS lesions (e.g., epilepsy surgery more than 6 months prior to receiving Sabril) may be enrolled.
Concurrent exposure to medications with known or suspected retinal or optic nerve toxicity.
Concurrent use of an investigational agent or device or such use within 30 days of entering the study.
Concurrent use of the ketogenic or similar diet.

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
SabrilAlso: VigabatrinSabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.	Drug	Sabril

Primary outcome

Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)
Time frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
Mean change from the reference value in 30-2 SITA mean deviation, which was generated using the University of Iowa Visual Field Reading Center (VFRC) normative database and the Humphrey Field Analyzer (HFA) normative database. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). The mean change from the reference value are presented for Months 3, 6, 9 and 12. A negative change from the reference value indicates a decrease in the central visual field.
Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography)
Time frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
Mean change from the reference value in average RNFL thickness (µm) as measured by SD-OCT. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). Thinning of the RNFL, that is, a negative change from the reference value, has been associated with ophthalmological disease.

Results and safety

Results posted to the registry on 7 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sabril	65	38

Primary outcome: Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)

Time frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12. Mean (Standard Deviation). Unit: dB

Measure	Sabril n = 55
VFRC database: Left eye, 3 months (N=50)	-0.28 (1.06)
VFRC database: Left eye, 6 months (N=45)	-0.24 (1.13)
VFRC database: Left eye, 9 months (N=39)	-0.14 (1.72)
VFRC database: Left eye, 12 months (N=36)	-0.13 (1.58)
VFRC database: Right eye, 3 months (N=50)	0.08 (1.20)
VFRC database: Right eye, 6 months (N=45)	-0.11 (1.40)
VFRC database: Right eye, 9 months (N=39)	0.02 (1.36)
VFRC database: Right eye, 12 months (N=36)	-0.27 (1.61)

Population analysed: All patients who had received at least one dose of investigational medicinal product and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).

Primary outcome: Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography)

Time frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12. Mean (Standard Deviation). Unit: µm

Measure	Sabril n = 55
Left eye, 3 months (N=54)	0.70 (2.56)
Left eye, 6 months (N=48)	4.15 (4.72)
Left eye, 9 months (N=44)	5.63 (4.30)
Left eye, 12 months (N=39)	6.45 (4.81)
Right eye, 3 months (N=52)	0.73 (2.20)
Right eye, 6 months (N=47)	4.21 (3.75)
Right eye, 9 months (N=43)	6.50 (4.67)
Right eye, 12 months (N=39)	7.19 (4.88)

Population analysed: All patients who had received at least one dose of IMP and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).

Adverse events

Time frame: Baseline to end of study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vigabatrin	9 of 65 (13.8%)	41 of 65 (63.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sabril in people with Adult Refractory Complex Partial Seizures, run by Lundbeck LLC at 22 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 0 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: finished, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 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?

Yes. Results are posted in the registry (first posted 7 Jun 2016). 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?

Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB) (time frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12). The study lists 2 primary outcomes in all. 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 NCT01278173.

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 7 Jun 2016.