A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00643136

Purpose

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

Condition	Intervention	Phase
Sleep Deprivation Epilepsies, Partial	Drug: Pregabalin Drug: Placebo	Phase III

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures Sleep Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population [ Time Frame: Endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in total sleep time [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
Change from baseline in sleep onset latency [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
Change from baseline in wake after sleep onset [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
Change from baseline in percent sleep spent in stages 3 and 4 [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
Change from baseline in percent sleep spent in REM stage [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ) [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale) [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
Adverse events and laboratory value changes [ Time Frame: Endpoint ] [ Designated as safety issue: Yes ]

Enrollment:	17
Study Start Date:	November 2002
Study Completion Date:	June 2004

Arms	Assigned Interventions
Pregabalin: Experimental	Drug: Pregabalin Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28
Placebo: Placebo Comparator	Drug: Placebo Matching placebo capsules twice daily for 28 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643136

Locations

Netherlands
Pfizer Investigational Site
HEEZE, Netherlands, 5591 VE
Pfizer Investigational Site
DEN HAAG, Netherlands, 2501 CK

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	1008-000-167
Study First Received:	March 19, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00643136 History of Changes
Health Authority:	Netherlands: The Dutch Health Inspectorate

Study placed in the following topic categories:

Epilepsies, Partial
Seizures
Sleep Disorders
Dyssomnias
Central Nervous System Diseases
Pregabalin
Brain Diseases
Sleep Deprivation

Signs and Symptoms
Epilepsy
Mental Disorders
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:

Epilepsies, Partial
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Dyssomnias
Sleep Disorders
Pregabalin
Brain Diseases
Pharmacologic Actions
Sleep Deprivation

Signs and Symptoms
Sensory System Agents
Epilepsy
Mental Disorders
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009