S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

NCT00630968 | Completed Phase 4

• 1 other identifier: N01031
• Study Type: interventional
• Target: 1,541
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.

Conditions

Epilepsy

Keywords

Levetiracetam; Keppra

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in seizure frequency.

  16-week treatment period

Secondary Outcomes (2)

• To further assess safety.

• The patient-weighted Quality Of Life In Epilepsy inventory.

Interventions

Levetiracetam (Keppra) DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Partial onset seizures, whether or not secondarily generalized;
• at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;
• using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.

You may not qualify if:

• Presence of known pseudoseizures within the last year;
• presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
• on felbamate with less than 18 months exposure;
• on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months;
• uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

Sponsors & Collaborators

• UCB Pharma: lead

Related Publications (3)

• Steinhoff BJ, Somerville ER, Van Paesschen W, Ryvlin P, Schelstraete I. The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy. Epilepsy Res. 2007 Aug;76(1):6-14. doi: 10.1016/j.eplepsyres.2007.06.002. Epub 2007 Aug 6.

  PMID: 17681453 RESULT

• Somerville ER, McLaughlin DB, Robinson MK, Berkovic SF. Adjunctive therapy of uncontrolled partial seizures with levetiracetam in Australian patients. Epilepsy Behav. 2007 Nov;11(3):338-42. doi: 10.1016/j.yebeh.2007.06.005. Epub 2007 Sep 11.

  PMID: 17851135 RESULT

• Genton P, Sadzot B, Fejerman N, Peltola J, Despland PA, Steinhoff B, Rektor I, Wroe S, Maubrey MC, Vandervelden C, van Hammee G, Schlit AF, van Paesschen W. Levetiracetam in a broad population of patients with refractory epilepsy: interim results of the international SKATE trial. Acta Neurol Scand. 2006 Jun;113(6):387-94. doi: 10.1111/j.1600-0404.2006.00647.x.

  PMID: 16674605 RESULT

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 7, 2008
• Study Start: August 1, 2000
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: November 15, 2013

Record last verified: 2009-09