Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin

NCT01128712 | Terminated Phase 4

• 1 other identifier: NEREG-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Epilepsy, Complex Partial

Outcome Measures

Primary Outcomes (1)

• 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.

  week 0 - week 6

Secondary Outcomes (1)

• Change in BDI , NHS3 , STAI , NDDI-E and seizure frequency

  week 0 - week 6

Study Arms (2)

Group 1

OTHER

Pregabalin (150mg/day)

Drug: Pregabalin

Group 2

OTHER

Pregabalin (450mg/day)

Drug: Pregabalin

Interventions

Pregabalin DRUG

150 mg /day

Also known as: Lyrica

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Northeast Regional Epilepsy Group: lead
• Pfizer: collaborator

Study Sites (1)

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Epilepsy, Complex Partial

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Evan Fertig, MD

  Northeast Regional Epilepsy Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 24, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

US (1)