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A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Den Haag, , 2501 CK Netherlands
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sleep Deprivation, Partial Epilepsies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Partial epileptic seizures

- Not taking more than 1 background antiepileptic drug at study entry

- Disturbed sleep

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- More than 1 secondarily generalized tonic/clonic seizure per week on average over the
previous 3 months

- Medical, psychological, or social conditions that could interfere with normal sleep

NCT00643136
Pfizer
Completed
A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures

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A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures
Pregabalin BID Add-on Trial: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Single-Center Sleep EEG Study in Patients With Partial Seizures and Sleep Disturbance Part B: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Pregabalin Add-on Treatment
The purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Sleep Deprivation
  • Epilepsies, Partial
  • Drug: Pregabalin
    Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28
  • Drug: Placebo
    Matching placebo capsules twice daily for 28 days
  • Experimental: Pregabalin
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
June 2004
Not Provided

Inclusion Criteria:

  • Partial epileptic seizures
  • Not taking more than 1 background antiepileptic drug at study entry
  • Disturbed sleep

Exclusion Criteria:

  • More than 1 secondarily generalized tonic/clonic seizure per week on average over the previous 3 months
  • Medical, psychological, or social conditions that could interfere with normal sleep
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00643136
1008-000-167
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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