Sabril Patient Registry

NCT01073579 | Completed DMC

• 2 other identifiers: 13101AOV1040
• Study Type: observational
• Target: 9,423
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with Sabril and the prescribers of Sabril.

Conditions

Infantile Spasms; Refractory Complex Partial Seizures in Adults

Keywords

Cryptogenic Infantile Spasms; Cryptogenic West Syndrome; Hypsarrhythmia; Infantile Spasms; Symptomatic Infantile Spasms; Symptomatic West Syndrome; West Syndrome; Refractory Complex Partial Seizures; Complex Partial Epilepsy; Complex Partial Seizure Disorder; Cryptogenic Partial Complex Epilepsy; Disorder, Complex Partial Seizures; Epilepsy, Cryptogenic, Partial Complex; Epilepsy, Psychic Equivalent; Epilepsy, Psychomotor; Epilepsy, Symptomatic, Partial Complex; Partial Complex Epilepsy, Cryptogenic; Partial Complex Epilepsy, Symptomatic; Seizure Disorder, Complex Partial; Symptomatic Partial Complex Epilepsy

Outcome Measures

Primary Outcomes (1)

• Characterize the prevalence, incidence, time to onset, progression, and severity of vision loss during Sabril treatment.

  A yearly report

Secondary Outcomes (2)

• Characterize the demographics, disease characteristics, dose and duration of therapy for patients who receive Sabril.

  A yearly report

• Characterize the physician specialties for prescribers of Sabril.

  A yearly report

Study Arms (1)

Sabril®

All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril.

Drug: Sabril®

Interventions

Sabril® DRUG

Infantile Spasms (IS): Initiate therapy at 50 mg/kg/day twice daily increasing total daily dose per instructions to a maximum of 150 mg/kg/day. Refractory Complex Partial Seizures (rCPS) in Adults: Initiate therapy at 500 mg twice daily, increasing total daily dose per instructions. The recommended dose is 1.5 grams twice daily.

Also known as: Vigabatrin

Sabril®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril. There are no other eligibility criteria for this study.

You may qualify if:

• All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril.

Sponsors & Collaborators

• Lundbeck LLC: lead

MeSH Terms

Conditions

Spasms, Infantile; Seizures; Epilepsy, Complex Partial

Interventions

Vigabatrin

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsies, Partial

Intervention Hierarchy (Ancestors)

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

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: August 1, 2009
• Primary Completion: July 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-07