Prospective Randomized 12-Week Controlled Study of Visual Field Change in Subjects with Partial Seizures Receiving Pregabalin or Placebo

Phase 1

Conditions: EPILEPSY WITH PARTIAL SEIZURE
MedDRA version: 17.0Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2009-014269-25-HU

Lead Sponsor: Pfizer Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 284

Inclusion Criteria

1. Diagnosis of epilepsy with partial seizures (as defined in the International League
Against Epilepsy Classification of Seizures). Diagnosis must be established by
subject’s medical history (eg, seizures), family history, and the results of
electroencephalogram testing done within 2 years prior to baseline (if none available,
must be taken during Screening). Results must be consistent with the diagnosis of
focal-onset epilepsy;
2. Seizures should not have occurred within 2 weeks of an acute neurological event
(eg, a stroke);
3. Be currently taking 1 to 3 antiepileptic drugs (AEDs). Vagus nerve stimulator (VNS) device also will be considered an AED. AED should be continued without alteration of current dose during the study. Benzodiazepines and barbiturates will not be allowed as -treatment regardless of indication;
4. Have magnetic resonance imaging (MRI) or computed tomography (CT) scan with contrast of the head within 3 years prior to randomization (if none available, must be taken during Screening) that demonstrates no progressive structural abnormality and non-lesional epilepsy;
5. Subjects who, in the opinion of the investigator, may benefit from treatment with
pregabalin;
6. Be 18 to 65 years old;
7. Be male, or nonpregnant, nonlactating female who is postmenopausal, surgically
sterilized, or premenopausal using a reliable method of contraception (including
barrier or hormonal method) and have a confirmed negative urine pregnancy test prior to randomization;
8. Have a 12-lead electrocardiogram prior to randomization without clinically
significant abnormal findings;
9. On both screening and baseline visual field exam, any eye has <20% false positives, <30% false negatives, <30% fixation loss;
10. Difference in mean deviation between screening and baseline visual field exams must be =2 decibels (dB) of mean deviation (MD) on both eyes;
11. Provide written informed consent signed by subject or legal guardian prior to entering the study;
12. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 284
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known previous or current serious ophthalmologic disease(including uncorrected cataracts or history of cataract surgery < 8 days), serious eye trauma or intra ocular or ocular surgery other than refractive (ie, lasik, cataract) surgery, or ophthalmologic finding that could affect the visual field; 2. Amblyopia;
3. Ptosis;
4. Manifest nystagmus in primary gaze;
5. On medications that could affect the visual field or pupil eg, chloroquine or miotics;
6. Refractive error in either eye exceeding +/-5 D (sphere) or +/-2.5 D (cylinder);
7. Best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity
worse than 20/25 in either eye;
8. Intra ocular pressure (IOP) >22 mmHg in either eye at Screening;
9. Have clinically significant abnormal findings on ophthalmologic examinations
including external eye examination, visual acuity test, intraocular pressure,
funduscopy and repeated visual field test (VFT). Repeat any test if there is a finding
that is uncertain. For VFT – if one test is normal and another one abnormal a third
test may be performed. Two of the three tests being normal is acceptable;
10. Subjects with glaucoma or a history of glaucoma;
11. Family history of inherited retinal or optic nerve disorders;
12. Subject with a history of intolerability to pregabalin, or with a history of
insufficient response (based on investigator’s clinical judgment) to pregabalin in the treatment of partial seizure, or subjects with current pregabalin treatment;
13. Subjects who currently have poorly controlled epileptic seizures which could
interfere with test procedures;
14. Childbearing potential female who is unable to take adequate contraceptive
precautions, has a positive pregnancy test result within 24 hours prior to study entry, is otherwise known to be pregnant, plans to become pregnant in the next 3 months or is currently breastfeeding an infant;
15. Creatinine clearance =60 mL/min (estimated from serum creatinine);
16. Have a history or clinical evidence of cardiovascular, hematologic, hepatic, or renal disease (ALT, AST, bilirubin, urea, or creatinine values above twice the upper limit of normal [ULN] at Screening) or any physical conditions that, in the opinion of the investigator, would compromise participation in the study;
17. With a mental condition rendering the subject unable to be cooperative with and
complete study requirements;
18. Have a significant psychiatric disorder, recurrent episodes of severe depression (any pharmacologic treatment or hospitalization for the illness within 1 year prior to
Screening), or subjects with serious suicidal risk per criteria described in the section
7.5.1 of the protocol. Subjects with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of a single antidepressant
are acceptable;
19. Has received any investigational drug during the previous 60 days prior to first dose;
20. Hypersensitivity to pregabalin or gabapentin;
21. Meets criteria for alcohol or drug abuse within the past year;
22. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or
investigational product administration or may interfere with the interpretation of trial
results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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