NCT00643136

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2002

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

April 24, 2008

Status Verified

April 1, 2008

First QC Date

March 19, 2008

Last Update Submit

April 23, 2008

Conditions

Sleep DeprivationEpilepsies, Partial

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population

    Endpoint

Secondary Outcomes (8)

  • Change from baseline in total sleep time

    Endpoint

  • 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 percent sleep spent in REM stage

    Endpoint

  • +3 more secondary outcomes

Study Arms (2)

Pregabalin

EXPERIMENTAL
Drug: Pregabalin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PregabalinDRUG

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

Pregabalin
PlaceboDRUG

Matching placebo capsules twice daily for 28 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Heeze, 5591 VE, Netherlands

Location

Pfizer Investigational Site

The Hague, 2501 CK, Netherlands

Location

Related Links

MeSH Terms

Conditions

Sleep DeprivationEpilepsies, Partial

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersEpilepsyBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 26, 2008

Study Start

November 1, 2002

Study Completion

June 1, 2004

Last Updated

April 24, 2008

Record last verified: 2008-04

Locations

NL(2)