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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.
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The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with refractory partial seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin | Experimental | open label treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin (LYRICA) | Drug | 150 mg up to a maximum of 600 mg per day bid or tid as required |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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. | Baseline up to Year 5 and follow-up (30 days after last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Seizures | 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. | Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Calgary | Alberta | T2N 2T9 | Canada | ||
| Pfizer Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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. | Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period. | Posted | Number | Participants | Baseline up to Year 5 and follow-up (30 days after last dose) |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Halifax |
| Nova Scotia |
| B3H 3A7 |
| Canada |
| Pfizer Investigational Site | Barrie | Ontario | L4M 4S5 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5C 1R6 | Canada |
| Pfizer Investigational Site | Windsor | Ontario | N8X 5A6 | Canada |
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mean Number of Seizures | 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. | Mean | Standard Deviation | Seizures |
|
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. |
|
|
| Secondary | Mean Number of Seizures | 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. | 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. | Posted | Mean | Standard Deviation | Seizures | Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose) |
|
|
|
| 3 |
| 21 |
| 21 |
| 21 |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Foetal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Vitamin B12 decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Vitamin D decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Anger | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
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.
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
|
| Month 24 to Month 30 (n = 18) |
|
| Month 30 to Month 36 (n = 18) |
|
| Month 36 to Month 42 (n = 17) |
|
| Month 42 to Month 48 (n = 11) |
|
| Month 54 or EOS (n = 19) |
|
| Follow-up (n = 14) |
|