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Trial record 1 of 1 for:    NCT01747915
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A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

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ClinicalTrials.gov Identifier: NCT01747915
Recruitment Status : Completed
First Posted : December 12, 2012
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Generalized Tonic Clonic Seizures
Interventions Drug: Pregabalin Dose Level 1
Drug: Pregabalin Dose Level 2
Drug: Placebo
Enrollment 219
Recruitment Details  
Pre-assignment Details The study was conducted at multiple sites in 21 countries in 219 participants between 03 April 2013 and 20 February 2019.
Arm/Group Title Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day Placebo
Hide Arm/Group Description Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks. Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks. Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
Period Title: Overall Study
Started 75 72 72
Completed 60 61 66
Not Completed 15 11 6
Reason Not Completed
Other             1             1             1
Adverse Event             8             5             2
Death             0             0             1
Lack of Efficacy             0             1             0
Lost to Follow-up             1             0             0
Withdrawal by Subject             4             4             1
Protocol Violation             1             0             0
Pregnancy             0             0             1
Arm/Group Title Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day Placebo Total
Hide Arm/Group Description Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks. Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks. Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 75 72 72 219
Hide Baseline Analysis Population Description
Intent to treat (ITT) population included all randomized participants who took at least 1 dose of investigational product during the double-blind treatment phase, have a baseline value and at least 1 post-baseline efficacy assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 72 participants 72 participants 219 participants
24.0  (13.3) 25.4  (12.7) 26.2  (13.2) 25.2  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 72 participants 72 participants 219 participants
Female
42
  56.0%
39
  54.2%
40
  55.6%
121
  55.3%
Male
33
  44.0%
33
  45.8%
32
  44.4%
98
  44.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 72 participants 72 participants 219 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
8
  10.7%
8
  11.1%
6
   8.3%
22
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
67
  89.3%
64
  88.9%
65
  90.3%
196
  89.5%
More than one race
0
   0.0%
0
   0.0%
1
   1.4%
1
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase
Hide Description All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {–} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Time Frame Day 1 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who took at least 1 dose of investigational product during the double-blind treatment phase, have a baseline value and at least 1 post-baseline efficacy assessment.
Arm/Group Title Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day Placebo
Hide Arm/Group Description:
Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
Overall Number of Participants Analyzed 75 72 72
Least Squares Mean (Standard Error)
Unit of Measure: Seizure per 28 days
1.17  (0.097) 1.13  (0.095) 1.14  (0.098)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day, Placebo
Comments Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8121
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.15 to 0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.088
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day, Placebo
Comments Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8889
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.19 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.088
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase
Hide Description Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {–} number of missing diary days in treatment phase])*28.
Time Frame Day 1 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who took at least 1 dose of investigational product during the double-blind treatment phase, have a baseline value and at least 1 post-baseline efficacy assessment.
Arm/Group Title Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day Placebo
Hide Arm/Group Description:
Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
Overall Number of Participants Analyzed 75 72 72
Measure Type: Number
Unit of Measure: percentage of participants
41.3 38.9 41.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7973
Comments P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.095
Confidence Interval (2-Sided) 95%
0.548 to 2.186
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8474
Comments P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.934
Confidence Interval (2-Sided) 95%
0.465 to 1.877
Estimation Comments [Not Specified]
Time Frame Day 1 up to end of study (Week 13)
Adverse Event Reporting Description Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
 
Arm/Group Title Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day Placebo
Hide Arm/Group Description Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks. Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks. Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
All-Cause Mortality
Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/72 (0.00%)   1/72 (1.39%) 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/75 (2.67%)   2/72 (2.78%)   3/72 (4.17%) 
General disorders       
Sudden unexplained death in epilepsy * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Nervous system disorders       
Generalised tonic-clonic seizure * 1  1/75 (1.33%)  2/72 (2.78%)  0/72 (0.00%) 
Seizure * 1  0/75 (0.00%)  0/72 (0.00%)  2/72 (2.78%) 
Status epilepticus * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
1
Term from vocabulary, MedDRA (v21.1)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/75 (52.00%)   41/72 (56.94%)   36/72 (50.00%) 
Blood and lymphatic system disorders       
Eosinophilia * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Ear and labyrinth disorders       
Hypoacusis * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Vertigo * 1  3/75 (4.00%)  2/72 (2.78%)  1/72 (1.39%) 
Eye disorders       
Diplopia * 1  1/75 (1.33%)  1/72 (1.39%)  1/72 (1.39%) 
Eye disorder * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Eye irritation * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Eye pain * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Vision blurred * 1  1/75 (1.33%)  1/72 (1.39%)  0/72 (0.00%) 
Visual impairment * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Gastrointestinal disorders       
Abdominal pain upper * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Constipation * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Dental caries * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Diarrhoea * 1  1/75 (1.33%)  1/72 (1.39%)  1/72 (1.39%) 
Dry mouth * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Dyspepsia * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Flatulence * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Gastritis * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Nausea * 1  2/75 (2.67%)  2/72 (2.78%)  1/72 (1.39%) 
Salivary hypersecretion * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Toothache * 1  0/75 (0.00%)  1/72 (1.39%)  1/72 (1.39%) 
Vomiting * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
General disorders       
Fatigue * 1  5/75 (6.67%)  3/72 (4.17%)  3/72 (4.17%) 
Influenza like illness * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Pyrexia * 1  1/75 (1.33%)  0/72 (0.00%)  2/72 (2.78%) 
Sluggishness * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Therapeutic response unexpected * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Infections and infestations       
Bronchitis * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Diarrhoea infectious * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Helicobacter infection * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Influenza * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Nasopharyngitis * 1  1/75 (1.33%)  2/72 (2.78%)  1/72 (1.39%) 
Otitis media acute * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Pharyngitis * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Pneumonia * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Rhinitis * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Tonsillitis * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Upper respiratory tract infection * 1  4/75 (5.33%)  2/72 (2.78%)  4/72 (5.56%) 
Urinary tract infection * 1  2/75 (2.67%)  0/72 (0.00%)  0/72 (0.00%) 
Varicella zoster virus infection * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Viral infection * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Viral rhinitis * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Viral upper respiratory tract infection * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Injury, poisoning and procedural complications       
Clavicle fracture * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Contusion * 1  1/75 (1.33%)  1/72 (1.39%)  0/72 (0.00%) 
Face injury * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Fall * 1  1/75 (1.33%)  2/72 (2.78%)  3/72 (4.17%) 
Foot fracture * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Head injury * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Joint dislocation * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Periorbital haematoma * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Skin injury * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Skin laceration * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Soft tissue injury * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Tooth fracture * 1  1/75 (1.33%)  1/72 (1.39%)  0/72 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Aspartate aminotransferase increased * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Blood alkaline phosphatase increased * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Blood creatine phosphokinase increased * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Blood glucose increased * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Blood pressure increased * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Platelet count increased * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Weight increased * 1  1/75 (1.33%)  7/72 (9.72%)  0/72 (0.00%) 
Lymphocyte morphology abnormal * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Increased appetite * 1  0/75 (0.00%)  1/72 (1.39%)  3/72 (4.17%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  2/75 (2.67%)  0/72 (0.00%)  0/72 (0.00%) 
Metatarsalgia * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Muscle spasms * 1  1/75 (1.33%)  0/72 (0.00%)  1/72 (1.39%) 
Muscular weakness * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Pain in extremity * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Back Pain * 1  1/75 (1.33%)  0/72 (0.00%)  1/72 (1.39%) 
Nervous system disorders       
Ataxia * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Disturbance in attention * 1  0/75 (0.00%)  1/72 (1.39%)  1/72 (1.39%) 
Dizziness * 1  13/75 (17.33%)  12/72 (16.67%)  5/72 (6.94%) 
Dysgraphia * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Epilepsy * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Head titubation * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Headache * 1  7/75 (9.33%)  11/72 (15.28%)  12/72 (16.67%) 
Hypoaesthesia * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Hypokinesia * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Memory impairment * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Myoclonic epilepsy * 1  1/75 (1.33%)  1/72 (1.39%)  0/72 (0.00%) 
Nystagmus * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Petit mal epilepsy * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Poor quality sleep * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Sedation * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Seizure * 1  1/75 (1.33%)  1/72 (1.39%)  0/72 (0.00%) 
Somnolence * 1  5/75 (6.67%)  11/72 (15.28%)  7/72 (9.72%) 
Tremor * 1  0/75 (0.00%)  2/72 (2.78%)  1/72 (1.39%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Psychiatric disorders       
Agitation * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Anxiety * 1  1/75 (1.33%)  1/72 (1.39%)  0/72 (0.00%) 
Anxiety disorder * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Apathy * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Bradyphrenia * 1  0/75 (0.00%)  2/72 (2.78%)  0/72 (0.00%) 
Confusional state * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Depressed mood * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Enuresis * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Epileptic psychosis * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Insomnia * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Irritability * 1  2/75 (2.67%)  0/72 (0.00%)  0/72 (0.00%) 
Mood swings * 1  1/75 (1.33%)  0/72 (0.00%)  1/72 (1.39%) 
Soliloquy * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Suicidal ideation * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Thinking abnormal * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Renal and urinary disorders       
Haematuria * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Leukocyturia * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Proteinuria * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Reproductive system and breast disorders       
Cervical polyp * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Dysmenorrhoea * 1  1/75 (1.33%)  0/72 (0.00%)  0/72 (0.00%) 
Menstruation irregular * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Vaginal discharge * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Rhinorrhoea * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Skin and subcutaneous tissue disorders       
Acne * 1  0/75 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Erythema * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Vascular disorders       
Haematoma * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Thrombosis * 1  0/75 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
1
Term from vocabulary, MedDRA (v21.1)
*
Indicates events were collected by non-systematic assessment
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: NCT01747915     History of Changes
Other Study ID Numbers: A0081105
2010-023263-18 ( EudraCT Number )
First Submitted: November 27, 2012
First Posted: December 12, 2012
Results First Submitted: August 8, 2019
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019