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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00643136

Enrollment

Registered

2008-03-26

Start date

2002-11-30

Completion date

2004-06-30

Last updated

2008-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsies, Partial, Sleep Deprivation

Brief summary

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

Interventions

DRUGPregabalin

Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28

DRUGPlacebo

Matching placebo capsules twice daily for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population	Endpoint

Secondary

Measure	Time frame
Change from baseline in sleep onset latency	Endpoint
Change from baseline in wake after sleep onset	Endpoint
Change from baseline in percent sleep spent in stages 3 and 4	Endpoint
Change from baseline in total sleep time	Endpoint
Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)	Endpoint
Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)	Endpoint
Adverse events and laboratory value changes	Endpoint
Change from baseline in percent sleep spent in REM stage	Endpoint

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026