A DOUBLE-BLIND, RANDOMIZED, MULTICENTER EFFICACY AND SAFETY STUDY OF PREGABALIN (LYRICA) AS MONOTHERAPY IN PATIENTS WITH PARTIAL SEIZURES

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-016849-25-CZ
• Date of registration: 04/01/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc
• Public title: A DOUBLE-BLIND, RANDOMIZED, MULTICENTER EFFICACY AND SAFETY STUDY OF PREGABALIN (LYRICA) AS MONOTHERAPY IN PATIENTS WITH PARTIAL SEIZURES
• Scientific title: A DOUBLE-BLIND, RANDOMIZED, MULTICENTER EFFICACY AND SAFETY STUDY OF PREGABALIN (LYRICA) AS MONOTHERAPY IN PATIENTS WITH PARTIAL SEIZURES
• Date of first enrolment: 15/03/2010
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016849-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Historical controlled

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
1. Diagnosis of epilepsy with partial seizures, as defined in the International League
Against Epilepsy (ILAE) classification of seizures (Appendix 3). Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization. Diagnosis must be established by the following: patient’s medical history (eg, seizures), excluding confounding disorders such as pseudo seizures, syncopes, etc., family history and the results of electroencephalograph (EEG) testing done within 2 years of the first patient visit. Results must be consistent with the diagnosis of focal-onset epilepsy;
2. Males or females, age 18 years or older;
3. Women must be nonpregnant and nonlactating, and must be using a barrier or
hormonal method of contraception; or must be post-menopausal, or surgically sterilized. All women must have a negative pregnancy test at Screening. Females who become pregnant will be discontinued from the study;
4. Minimum body weight of 90 lbs;
5. Documented history of at least 4 partial seizures in the 8 weeks prior to the
Screening Visit (V1);
6. Stable treatment with 1-2 AEDs in the 8 weeks prior to the Screening Visit (V1);
7. Seizure frequency of at least 4 partial seizures in the 8-week Baseline phase, with
no 4-week seizure-free period;
8. Electrocardiogram (ECG) without significant abnormal findings (Section 7.2.4.);
9. A computed tomography (CT) or magnetic resonance imaging (MRI) scan within
2 years of the Screening Visit (V1) demonstrating no progressive structural abnormality;
10. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
study procedures, diary completion and other trial procedures;
11. Willing and able to give written informed consent by evidence of a personally
signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Current diagnosis of febrile seizures or seizures related to an ongoing acute medical illness;
2. Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin;
3. Primary generalized epilepsy (eg, absence epilepsy);
4. Progressive structural CNS lesion or a progressive encephalopathy;
5. Status epilepticus within the previous year;
6. Any significant psychiatric disorder or recurrent episodes of severe depression (defined as any pharmacologic treatment or hospitalization for the illness within 1 year prior to the Screening Visit, V1). Patients with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of a single antidepressant are acceptable;
7. Current or within the last 6 months, white blood cell (WBC) count of <2500 cells/µL or a neutrophil count of <1500 cells/µL or a platelet count of <100 x 103 cells/µL, or a history of bone marrow suppression;
8. History or clinical evidence of cardiovascular, hematologic, hepatic, or renal disease;
9. CLcr =60 mL/min (estimated from serum creatinine);
10. Current treatment with benzodiazepines and/or barbiturates if used for any indication other than epilepsy
11. Concomitant non-antiepileptic medication (eg, neuroleptic drugs) that could alter
the effectiveness of the study medication response or affect seizure frequency;
12. Alcohol or substance abuse or dependence unless in full remission for at least 12 months;
13. Participation in any clinical trial within the 30 days before the Screening Visit (V1);
14. 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.
15. Previous use of pregabalin.
16. History of poor compliance with AED therapy.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Partial Seizures
MedDRA version: 12.1 Level: LLT Classification code 10061334 Term: Partial seizures

Intervention(s)

Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
CAS Number: 148-553-50-8
Current Sponsor code: N/A
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
CAS Number: 148-553-50-8
Current Sponsor code: N/A
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
CAS Number: 148-553-50-8
Current Sponsor code: N/A
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 225-

Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
CAS Number: 148-553-50-8
Current Sponsor code: N/A
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Main Objective: To assess the efficacy of pregabalin as monotherapy in the treatment of patients with partial seizures who are not well controlled on current antiepileptic drug (AED) treatment. Safety data will also be collected and analyzed.

Secondary Objective: There are no secondary objectives, just the one main objective in E.2.1

Primary end point(s): The primary efficacy endpoint of this trial is the percent of subjects who meet at least one of the following predetermined exit criteria listed below.
1. An episode of status epilepticus;
2. A secondarily generalized tonic-clonic seizure if none had been experienced within 2 years of study entry;
3. A 28-day study seizure rate during the double-blind treatment phase that was greater than two times the maximum 28-day study seizure rate during the baseline phase (a 28-day period is defined as 28 consecutive study days);
4. A 2-day study seizure rate during the double-blind treatment phase that was greater than two times the maximum 2-day study seizure rate during the baseline phase (a 2-day period is defined as 2 consecutive study days);
5. An unacceptable increase in the frequency or intensity of seizure activity that,
according to the investigator, is clinically significant.

Secondary ID(s)

A0081047