Epilepsy, Complex PartialPhase 4NCT01128712
Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin
A Phase 4 study testing Pregabalin in people with Epilepsy, Complex Partial, run by Northeast Regional Epilepsy Group at 1 site in United States.
Trial summary
To prospectively demonstrate the superior anxiolytic effect of high dose pregabalin (PGB) therapy (450 mg/day) compared to low dose PGB therapy (150 mg/day) in subjects with medically refractory partial epilepsy not fully controlled despite treatment with 1-2 concomitant antiepileptic drugs (AEDs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy, Complex Partial
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jul 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An IRB-approved consent form signed and dated by the subject
- A diagnosis of partial epilepsy which is drug resistant according to the International League Against Epilepsy criteria (Failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom). Furthermore to meet the ILAE definition of drug resistance, subjects will have had breakthrough seizures occurring at a frequency of less than 3 times the longest pretreatment interseizure interval or every 12 months, which ever is longer.
- Subjects that score ≥18 on Beck Anxiety Inventory will be included in the study
- Subjects from 18 to 75 years, both inclusive.
- Females without childbearing potential or childbearing potential using medically accepted forms of birth control (pre-menarcheal, post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy, or medically accepted form of contraception).
- Subject judged by the Investigator to be reliable and capable of adhering to the protocol, visit schedules, and able to understand and complete study instruments.
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- CT or MRI scan performed within 2 years of screening and without evidence of a progressive lesion or neurological condition.
- Electroencephalogram consistent with partial epilepsy and does not demonstrate generalized spike wave.
- Currently treated with a stable dose of 1-2 AEDs for a minimum of 4 weeks (3 months for phenobarbital and primidone). Benzodiazepines used as a rescue therapy for seizures and used no more than once a week will be permitted.
Who cannot join
- History of psychogenic non-epileptic seizures.
- The subject is pregnant or lactating.
- Women with reproductive potential who refuse to use medically accepted forms of birth control.
- Presence of any clinically significant laboratory abnormality which in the judgement of the investigator should exclude the subject from the study.
- Presence of any progressive, demyelinating, or degenerative neurological condition.
- Subject is currently taking gabapentin.
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- History of an allergic reaction to gabapentin or PGB.
- History of worsened seizures or serious adverse reactions to gabapentin.
- History of suicide attempt.
- No active suicidal plan/intent or active suicidal thoughts in the last 6 months.
- Current use or use within the previous three months prior to screening of antidepressant, anxiolytic, or antipsychotic agents. Subjects using benzodiazepines for anxiety will not be permitted.
- Diagnosis of Bipolar Disorder, Schizophrenia, psychotic disorder (excluding post-ictal psychosis), Major Depression requiring hospitalization in the past 2 years, or other psychological or behavioral condition which in the judgement of the investigator should exclude the subject from the study.
- A history of alcoholism, drug abuse, or drug addiction within the last 2 years.
- Any contraindication to use of PGB.
- Any clinical condition (e.g. severe renal impairment, chronic hepatic disease, serious infection, and or bone marrow depression) which will impair participation in the trial.
- History of multiple drug allergies or severe drug allergy.
- Subjects with vagal nerve stimulators (VNS).
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
About this study
Official title: An Open Label, Randomized Study Prospectively Examining the Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin
To prospectively demonstrate the superior anxiolytic effect of high dose pregabalin (PGB) therapy (450 mg/day) compared to low dose PGB therapy (150 mg/day) in subjects with medically refractory partial epilepsy not fully controlled despite treatment with 1-2 concomitant antiepileptic drugs (AEDs).
Read the detailed description
Background
Interictal anxiety symptoms are reported in two-thirds of patients with epilepsy and represent an underrecognized and undertreated aspect of the disorder. Interictal anxiety is postulated to stem from both fear of seizure recurrence ("seizure phobia") and dispersed locus of control.In addition, anxiety and the most common forms of partial onset epilepsy are viewed to arise from dysfunction in a common neurobiological substrate-the amygdala and other structures within the limbic system.
Background on Pregabalin
Pregabalin (CI-1008,Lyrica) is a chemical analogue of the mammalian neurotransmitter gamma-aminobutyric acid (GABA),although it does not bind to or activates GABA receptors or inhibit GABA uptake. Pregabalin is an alpha-2-delta ligand that has analgesic, anxiolytic, and antiepileptic activity.
Rationale
Antiepileptic drugs (AEDs) are commonly used for mood disorders including anxiety.Pregabalin (PGB) the most recently FDA-approved AED for add-on therapy for refractory partial seizures also has demonstrated efficacy in Generalized Anxiety Disorder. PGB binds to the alpha-2-delta subunit protein of voltage-gated calcium channels, and in animal models, has anxiolytic and anti-epileptic effects via pre-synaptic inhibition of the release of several excitatory neurotransmitters.
- Conditions
- Epilepsy, Complex Partial
- Being tested
- Pregabalin
- Medical subject headings
- Epilepsy, Complex Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
150 mg /day
PregabalinDrug
Also called Lyrica
450 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Pregabalin (150mg/day) Receives: Drug: Pregabalin |
| Group 2 | Other | Pregabalin (450mg/day) Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Anxiety Score
The primary outcome variable will be the change in the Beck Anxiety Inventory (BAI) score as measured at the baseline and final visits.
Measured: week 0 - week 6
Secondary outcomes (1)
Change in BDI , NHS3 , STAI , NDDI-E and seizure frequency
The secondary outcome variables will be the change in the Beck Depression Inventory, change in National Hospital Seizure Severity Scale (NHS3) score, change in seizure frequency, change in Stait-Trait Anxiety Scale (STAI),and change in the National Disorders Depression Inventory for Epilepsy Screening Tool (NDDI-E) as measured at the baseline and final visits.
Measured: week 0 - week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: lack of enrollment. terminated in 2014. no data analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Complex PartialStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeast Regional Epilepsy Group
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Evan Fertig, Northeast Regional Epilepsy Group
- Investigators
- Evan Fertig, MD, Principal investigator, Northeast Regional Epilepsy Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128712
- Sponsor's protocol ID
- NEREG-001
- Status last verified
- Sep 2017
- First submitted
- 20 May 2010
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized Study Prospectively Examining the Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin
- ClinicalTrials.gov ID
- NCT01128712
- Acronym / sponsor ID
- NEREG-001
- Conditions
- Epilepsy, Complex Partial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment. terminated in 2014. no data analysis.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northeast Regional Epilepsy GroupUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 May 2010 (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.
To prospectively demonstrate the superior anxiolytic effect of high dose pregabalin (PGB) therapy (450 mg/day) compared to low dose PGB therapy (150 mg/day) in subjects with medically refractory partial epilepsy not fully controlled despite treatment with 1-2 concomitant antiepileptic drugs (AEDs).
Detailed description
Background
Interictal anxiety symptoms are reported in two-thirds of patients with epilepsy and represent an underrecognized and undertreated aspect of the disorder. Interictal anxiety is postulated to stem from both fear of seizure recurrence ("seizure phobia") and dispersed locus of control.In addition, anxiety and the most common forms of partial onset epilepsy are viewed to arise from dysfunction in a common neurobiological substrate-the amygdala and other structures within the limbic system.
Background on Pregabalin
Pregabalin (CI-1008,Lyrica) is a chemical analogue of the mammalian neurotransmitter gamma-aminobutyric acid (GABA),although it does not bind to or activates GABA receptors or inhibit GABA uptake. Pregabalin is an alpha-2-delta ligand that has analgesic, anxiolytic, and antiepileptic activity.
Rationale
Antiepileptic drugs (AEDs) are commonly used for mood disorders including anxiety.Pregabalin (PGB) the most recently FDA-approved AED for add-on therapy for refractory partial seizures also has demonstrated efficacy in Generalized Anxiety Disorder. PGB binds to the alpha-2-delta subunit protein of voltage-gated calcium channels, and in animal models, has anxiolytic and anti-epileptic effects via pre-synaptic inhibition of the release of several excitatory neurotransmitters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: PregabalinPregabalin (150mg/day) |
| Group 2 | Other | Drug: PregabalinPregabalin (450mg/day) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- An IRB-approved consent form signed and dated by the subject
- A diagnosis of partial epilepsy which is drug resistant according to the International League Against Epilepsy criteria (Failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom). Furthermore to meet the ILAE definition of drug resistance, subjects will have had breakthrough seizures occurring at a frequency of less than 3 times the longest pretreatment interseizure interval or every 12 months, which ever is longer.
- Subjects that score ≥18 on Beck Anxiety Inventory will be included in the study
- Subjects from 18 to 75 years, both inclusive.
- Females without childbearing potential or childbearing potential using medically accepted forms of birth control (pre-menarcheal, post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy, or medically accepted form of contraception).
Key exclusion criteria (17 listed)
- History of psychogenic non-epileptic seizures.
- The subject is pregnant or lactating.
- Women with reproductive potential who refuse to use medically accepted forms of birth control.
- Presence of any clinically significant laboratory abnormality which in the judgement of the investigator should exclude the subject from the study.
- Presence of any progressive, demyelinating, or degenerative neurological condition.
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 |
|---|---|---|
| PregabalinAlso: Lyrica150 mg /day | Drug | Group 1 |
| PregabalinAlso: Lyrica450 mg/day | Drug | Group 2 |
Primary outcome
Change in Beck Anxiety Score
Time frame: week 0 - week 6
The primary outcome variable will be the change in the Beck Anxiety Inventory (BAI) score as measured at the baseline and final visits.
1 secondary outcome
Change in BDI , NHS3 , STAI , NDDI-E and seizure frequency
Time frame: week 0 - week 6
Results and safety
The study was stopped early (reason given: lack of enrollment. terminated in 2014. no data analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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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.
Evan Fertig, MD principal investigator
Northeast Regional Epilepsy Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Epilepsy, Complex Partial, run by Northeast Regional Epilepsy Group at 1 site 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 9 inclusion and 17 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: lack of enrollment. terminated in 2014. no data analysis.). Results are not available in the source record.
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?
Change in Beck Anxiety Score (time frame: week 0 - week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2017.