Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks

NCT00279617 | Completed Phase 3

• 1 other identifier: 2-Miefert
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this research study is to determine whether the drug Levetiracetam (Keppra™) is effective in the prevention of panic attacks. The drug Levetiracetam (Keppra™) has been approved for the treatment of seizures by the U.S. Federal Food and Drug Administration (FDA) and is available by prescription. Levetiracetam has not been approved by the FDA for the treatment of panic disorder.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety scale (HAM-A)

  each visit

Study Arms (1)

Levetricetam

ACTIVE COMPARATOR

open label treatment

Drug: levetiracetam

Interventions

levetiracetam DRUG

open label levetricetam

Also known as: Keppra

Levetricetam

Eligibility Criteria

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

You may qualify if:

• Outpatient subjects age 18 years or older.
• Subjects must meet DSM-IV-TR criteria for panic disorder with or without agoraphobia.
• Subjects must experience a minimum of one panic attack per week over the month preceding the study.
• Subjects must be fluent in English.
• Subjects must be able to provide and understand written informed consent.

You may not qualify if:

• Subjects unable to provide and understand written informed consent.
• Subjects previously treated with levetiracetam.
• Subjects who meet DVM-IV-TR criteria for current diagnosis of mood, psychotic or substance use disorder.
• Subjects who have acute or unstable medical illness.
• Subjects with a history of seizures or structural brain damage from trauma.
• Subjects currently receiving successful treatment for panic disorder (i.e., subjects will not have medications discontinued to participate in the study if they are effective in the treatment of their panic attacks).
• Subjects susceptible to lactate infusions.
• Female subjects who are pregnant or lactating.
• Female subjects who, if fertile, are not using medically acceptable and reliable method of contraception.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• UCB Pharma: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0559, United States

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paul Keck, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 19, 2006
• Study Start: January 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

US (1)