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An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures

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ClinicalTrials.gov Identifier: NCT00372528
Recruitment Status : Terminated (This study was terminated on April 8, 2011 as Pfizer Canada could no longer supply study drug. No efficacy or safety concerns factored into this decision.)
First Posted : September 7, 2006
Results First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: pregabalin (LYRICA)
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregabalin
Hide Arm/Group Description Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
Period Title: Overall Study
Started 21
Completed 0
Not Completed 21
Reason Not Completed
Lack of Efficacy             1
Adverse Event             1
Study Terminated by Sponsor             18
Other             1
Arm/Group Title Pregabalin
Hide Arm/Group Description Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
44.0  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
12
  57.1%
Male
9
  42.9%
Mean Number of Seizures   [1] 
Mean (Standard Deviation)
Unit of measure:  Seizures
Number Analyzed 21 participants
30.70  (40.63)
[1]
Measure Description: Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated from baseline visit to 1 day before Month 6 visit.
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to Year 5 and follow-up (30 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Participants
AEs 21
SAEs 3
2.Secondary Outcome
Title Mean Number of Seizures
Hide Description Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.
Time Frame Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who had received at least 1 dose of study medication in the open label period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable between each visit.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Seizures
Month 6 to Month 12 (n = 20) 35.10  (46.92)
Month 12 to Month 18 (n = 18) 29.70  (26.05)
Month 18 to Month 24 (n = 19) 27.80  (28.75)
Month 24 to Month 30 (n = 18) 32.50  (33.91)
Month 30 to Month 36 (n = 18) 29.30  (29.13)
Month 36 to Month 42 (n = 17) 28.70  (28.38)
Month 42 to Month 48 (n = 11) 24.80  (32.99)
Month 54 or EOS (n = 19) 22.90  (24.57)
Follow-up (n = 14) 6.40  (6.39)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Pregabalin
Hide Arm/Group Description Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
All-Cause Mortality
Pregabalin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin
Affected / at Risk (%)
Total   3/21 (14.29%) 
Infections and infestations   
Lung infection * 1  1/21 (4.76%) 
Urinary tract infection * 1  1/21 (4.76%) 
Injury, poisoning and procedural complications   
Overdose * 1  1/21 (4.76%) 
Nervous system disorders   
Grand mal convulsion * 1  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin
Affected / at Risk (%)
Total   21/21 (100.00%) 
Blood and lymphatic system disorders   
Thrombocytopenia * 1  1/21 (4.76%) 
Cardiac disorders   
Cyanosis * 1  1/21 (4.76%) 
Myocardial infarction * 1  1/21 (4.76%) 
Ear and labyrinth disorders   
Cerumen impaction * 1  1/21 (4.76%) 
Deafness * 1  1/21 (4.76%) 
Tympanic membrane perforation * 1  1/21 (4.76%) 
Eye disorders   
Visual acuity reduced * 1  1/21 (4.76%) 
Gastrointestinal disorders   
Diarrhoea * 1  2/21 (9.52%) 
Gastrooesophageal reflux disease * 1  2/21 (9.52%) 
Haematochezia * 1  1/21 (4.76%) 
Nausea * 1  1/21 (4.76%) 
Toothache * 1  1/21 (4.76%) 
Vomiting * 1  2/21 (9.52%) 
General disorders   
Asthenia * 1  1/21 (4.76%) 
Influenza like illness * 1  1/21 (4.76%) 
Malaise * 1  1/21 (4.76%) 
Infections and infestations   
Ear infection * 1  1/21 (4.76%) 
Herpes zoster * 1  1/21 (4.76%) 
Labyrinthitis * 1  1/21 (4.76%) 
Nasopharyngitis * 1  2/21 (9.52%) 
Otitis externa * 1  1/21 (4.76%) 
Pneumonia * 1  1/21 (4.76%) 
Upper respiratory tract infection * 1  1/21 (4.76%) 
Urinary tract infection * 1  1/21 (4.76%) 
Wound infection * 1  1/21 (4.76%) 
Injury, poisoning and procedural complications   
Back injury * 1  1/21 (4.76%) 
Epicondylitis * 1  1/21 (4.76%) 
Excoriation * 1  1/21 (4.76%) 
Fall * 1  10/21 (47.62%) 
Foetal exposure during pregnancy * 1  1/21 (4.76%) 
Foot fracture * 1  2/21 (9.52%) 
Hand fracture * 1  1/21 (4.76%) 
Head injury * 1  2/21 (9.52%) 
Joint injury * 1  1/21 (4.76%) 
Laceration * 1  4/21 (19.05%) 
Limb injury * 1  1/21 (4.76%) 
Scratch * 1  1/21 (4.76%) 
Thermal burn * 1  1/21 (4.76%) 
Toxicity to various agents * 1  1/21 (4.76%) 
Investigations   
Blood alkaline phosphatase increased * 1  1/21 (4.76%) 
Blood iron decreased * 1  1/21 (4.76%) 
Electrocardiogram abnormal * 1  2/21 (9.52%) 
Liver function test abnormal * 1  1/21 (4.76%) 
Vitamin B12 decreased * 1  1/21 (4.76%) 
Vitamin D decreased * 1  1/21 (4.76%) 
Weight decreased * 1  2/21 (9.52%) 
Weight increased * 1  3/21 (14.29%) 
Metabolism and nutrition disorders   
Diabetes mellitus * 1  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/21 (9.52%) 
Back pain * 1  1/21 (4.76%) 
Joint swelling * 1  1/21 (4.76%) 
Neck pain * 1  1/21 (4.76%) 
Osteoarthritis * 1  1/21 (4.76%) 
Osteoporosis * 1  1/21 (4.76%) 
Pain in extremity * 1  4/21 (19.05%) 
Nervous system disorders   
Balance disorder * 1  1/21 (4.76%) 
Carotid artery occlusion * 1  1/21 (4.76%) 
Convulsion * 1  2/21 (9.52%) 
Dizziness * 1  1/21 (4.76%) 
Headache * 1  4/21 (19.05%) 
Lethargy * 1  1/21 (4.76%) 
Memory impairment * 1  1/21 (4.76%) 
Somnolence * 1  1/21 (4.76%) 
Tremor * 1  1/21 (4.76%) 
Psychiatric disorders   
Anger * 1  1/21 (4.76%) 
Anxiety * 1  2/21 (9.52%) 
Confusional state * 1  1/21 (4.76%) 
Depression * 1  3/21 (14.29%) 
Insomnia * 1  1/21 (4.76%) 
Mood altered * 1  1/21 (4.76%) 
Panic attack * 1  1/21 (4.76%) 
Stress * 1  2/21 (9.52%) 
Suicidal ideation * 1  1/21 (4.76%) 
Reproductive system and breast disorders   
Dysmenorrhoea * 1  1/21 (4.76%) 
Vaginal haemorrhage * 1  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/21 (4.76%) 
Cough * 1  1/21 (4.76%) 
Vascular disorders   
Hypertension * 1  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
This was a compassionate use study and no formal primary outcome measure was specified a priori. Descriptive safety data were collected, subsequently safety outcome was designated as primary outcome as per National Institute of Health (NIH) criteria.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00372528     History of Changes
Other Study ID Numbers: A0081140
First Submitted: September 5, 2006
First Posted: September 7, 2006
Results First Submitted: September 21, 2012
Results First Posted: October 23, 2012
Last Update Posted: October 23, 2012