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Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Neurology Center, P.C.
Mobile, Alabama, 36607 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Epilepsies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Epilepsy partial seizure subjects.

- Currently taking 1 to 3 antiepileptic drugs.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pre-existing eye diseases (glaucoma).

- Insufficient response to pregabalin in the treatment of partial seizure, or patients
currently receiving pregabalin treatment.

NCT00351611
Pfizer
Recruiting
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo

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[email protected]

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Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
Prospective Randomized 12-week Controlled Study Of Visual Field Change In Subjects With Partial Seizures Receiving Pregabalin Or Placebo
Patients with partial seizures currently taking 1-3 antiepileptic medications will have a 50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to their current medications for 3 months. Neither the study doctor nor the patient will know the medication assignment. Vision testing will be performed prior to receiving the study treatment and at the end of the study to see if there are any changes.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Epilepsies, Partial
  • Drug: Lyrica (pregabalin)
    150 mg twice a day, oral administration
  • Drug: placebo
    Twice a day, oral administration
  • Experimental: Active
    Active drug
    Intervention: Drug: Lyrica (pregabalin)
  • Placebo Comparator: Placebo
    placebo comparator
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
284
November 11, 2019
November 11, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Epilepsy partial seizure subjects.
  • Currently taking 1 to 3 antiepileptic drugs.

Exclusion Criteria:

  • Pre-existing eye diseases (glaucoma).
  • Insufficient response to pregabalin in the treatment of partial seizure, or patients currently receiving pregabalin treatment.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Bulgaria,   Czechia,   Hungary,   India,   Korea, Republic of,   Mexico,   Poland,   Thailand,   United States
Czech Republic
 
NCT00351611
A0081096
2009-014269-25 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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