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

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643136
• Other study ID #: 1008-000-167
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2008
• Last updated: April 23, 2008
• Start date: November 2002
• Est. completion date: June 2004

Study information

• Verified date: April 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Dutch Health Inspectorate
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Sleep Deprivation

Intervention

Drug:
• Pregabalin
Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28
• Placebo
Matching placebo capsules twice daily for 28 days

Locations

Country	Name	City	State
Netherlands	Pfizer Investigational Site	Den Haag
Netherlands	Pfizer Investigational Site	Heeze

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population		Endpoint	No
Secondary	Change from baseline in total sleep time		Endpoint	No
Secondary	Change from baseline in sleep onset latency		Endpoint	No
Secondary	Change from baseline in wake after sleep onset		Endpoint	No
Secondary	Change from baseline in percent sleep spent in stages 3 and 4		Endpoint	No
Secondary	Change from baseline in percent sleep spent in REM stage		Endpoint	No
Secondary	Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)		Endpoint	No
Secondary	Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)		Endpoint	No
Secondary	Adverse events and laboratory value changes		Endpoint	Yes

External Links

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