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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00922987
Other study ID # A0081236
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2009
Est. completion date June 2010

Study information

Verified date July 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.


Description:

- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).


Recruitment information / eligibility

Status Completed
Enrollment 286
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients with partial seizures. Exclusion Criteria: - Contraindications according to Summary of Product Characteristics (SmPC).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lyrica (pregabalin)
The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)

Locations

Country Name City State
Slovakia Pfizer Investigational Site Banska Bystrica
Slovakia Pfizer Investigational Site Banska Bystrica
Slovakia Pfizer Investigational Site Bardejov
Slovakia Pfizer Investigational Site Bojnice
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Bratislava 1
Slovakia Pfizer Investigational Site Bratislava 2
Slovakia Pfizer Investigational Site Bratislava 3
Slovakia Pfizer Investigational Site Bratislava 4
Slovakia Pfizer Investigational Site Cadca
Slovakia Pfizer Investigational Site Dolny Kubin
Slovakia Pfizer Investigational Site Dubnica nad Vahom
Slovakia Pfizer Investigational Site Dunajska Streda
Slovakia Pfizer Investigational Site Handlova
Slovakia Pfizer Investigational Site Hlohovec
Slovakia Pfizer Investigational Site Humenne
Slovakia Pfizer Investigational Site Kemarok
Slovakia Pfizer Investigational Site Komarno
Slovakia Pfizer Investigational Site Kosice
Slovakia Pfizer Investigational Site Kosice 1
Slovakia Pfizer Investigational Site Kosice 1
Slovakia Pfizer Investigational Site Kosice 2
Slovakia Pfizer Investigational Site Kosice 4
Slovakia Pfizer Investigational Site Kosice 4
Slovakia Pfizer Investigational Site Krompachy
Slovakia Pfizer Investigational Site Levice
Slovakia Pfizer Investigational Site Levoca
Slovakia Pfizer Investigational Site Liptovsky Mikulas
Slovakia Pfizer Investigational Site Malacky
Slovakia Pfizer Investigational Site Martin
Slovakia Pfizer Investigational Site Martin
Slovakia Pfizer Investigational Site Modra
Slovakia Pfizer Investigational Site Myjava
Slovakia Pfizer Investigational Site Nitra
Slovakia Pfizer Investigational Site Nove Mesto nad Vahom
Slovakia Pfizer Investigational Site Nove Zamky
Slovakia Pfizer Investigational Site Nove Zamky
Slovakia Pfizer Investigational Site Piestany
Slovakia Pfizer Investigational Site Poltar
Slovakia Pfizer Investigational Site Presov
Slovakia Pfizer Investigational Site Puchov
Slovakia Pfizer Investigational Site Ruzomberok
Slovakia Pfizer Investigational Site Ruzomberok
Slovakia Pfizer Investigational Site Sahy
Slovakia Pfizer Investigational Site Sered
Slovakia Pfizer Investigational Site Skalica
Slovakia Pfizer Investigational Site Snina
Slovakia Pfizer Investigational Site Spisska Nova Ves
Slovakia Pfizer Investigational Site Surany
Slovakia Pfizer Investigational Site Trebisov
Slovakia Pfizer Investigational Site Trencin
Slovakia Pfizer Investigational Site Trnava
Slovakia Pfizer Investigational Site Trnava
Slovakia Pfizer Investigational Site Trstena
Slovakia Pfizer Investigational Site Vranov Nad Toplov
Slovakia Pfizer Investigational Site Zilina
Slovakia Pfizer Investigational Site Zilina
Slovakia Pfizer Investigational Site Zlate Moravce
Slovakia Pfizer Investigational Site Zvolen
Slovakia Pfizer Investigational Site Zvolen

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Concomitant Drug Treatments Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study. Baseline through Week 16 or ET
Other Number of Participants With Concomitant Co-morbidities Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable. Baseline through week 16 or ET
Primary Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit. Baseline through week 16 or early termination (ET)
Secondary Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit. Baseline and week 16 or ET
Secondary Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study. Week 4 through week 16 or ET
Secondary Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety). Baseline, week 4 and week 16 or ET
Secondary Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Baseline
Secondary Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).
At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse.
Week 16 or ET
Secondary Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute. Baseline and week 16 or ET
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