A Study of Lyrica as Treatment for Sleep Problems in Pati... | NCT00643136

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

NCT00643136

Sponsor

Pfizer

Status

Completed

Last Update Posted

Apr 24, 2008Estimated

Enrollment

17Actual

Phase

Phase 3

Conditions

Sleep Deprivation
Epilepsies, Partial

Interventions

Pregabalin
Placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Not provided

Completion Date

Jun 2004Actual

First Submitted Date

Mar 19, 2008

First Submission Date that Met QC Criteria

Mar 19, 2008

First Posted Date

Mar 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2008

Last Update Posted Date

Apr 24, 2008Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregabalin	Experimental		Drug: Pregabalin
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin	Drug	Pregabalin capsules 75 mg twice daily on Days 1-4, then 150 mg twice daily on Days 5-28	Pregabalin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in total sleep time		Endpoint
Change from baseline in sleep onset latency		Endpoint
Change from baseline in wake after sleep onset

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Heeze		5591 VE	Netherlands
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D012892	Sleep Deprivation
D004828	Epilepsies, Partial

Ancestor Terms

ID	Term
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069583	Pregabalin

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided