Clinical Study With Lyrica In Patients Suffering From Epilepsy

Epilepsy Clinical Trial

Official title:

Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922987
• Other study ID #: A0081236
• Status: Completed
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: July 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• 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).

Related Conditions & MeSH terms

• Epilepsy
• Neuralgia

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

External Links

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