Trial Outcomes & Findings for Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency (NCT NCT00684424)
NCT ID: NCT00684424
Last Updated: 2021-02-10
Results Overview
Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase \* 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.
COMPLETED
199 participants
Baseline through Week 16
2021-02-10
Participant Flow
Subjects were recruited from 36 medical centers and participated in the study between 11 July 2008 and 30 March 2009.
Participant milestones
| Measure |
Pregabalin (Lyrica)
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Overall Study
STARTED
|
199
|
|
Overall Study
COMPLETED
|
194
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Pregabalin (Lyrica)
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Baseline characteristics by cohort
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Age, Customized
<=18 years
|
2 participants
n=5 Participants
|
|
Age, Customized
18 - 44 years
|
104 participants
n=5 Participants
|
|
Age, Customized
45 - 65 years
|
60 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
33 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 16Population: Full Analysis Set: all subjects who received at least 1 dose of study drug and had at least 1 efficacy measurement.
Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase \* 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency
Responders
|
138 participants
|
|
Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency
Non-Responders
|
44 participants
|
|
Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency
Missing
|
17 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Safety analysis set: all subjects who received at least 1 dose of study medication.
Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Antiepileptic Drugs Used in the Past
Barbiturates
|
42 participants
|
|
Antiepileptic Drugs Used in the Past
Carbamazepine
|
93 participants
|
|
Antiepileptic Drugs Used in the Past
Gabapentin
|
30 participants
|
|
Antiepileptic Drugs Used in the Past
Lamotrigine
|
38 participants
|
|
Antiepileptic Drugs Used in the Past
Levetiracetam
|
26 participants
|
|
Antiepileptic Drugs Used in the Past
Phenytoin
|
66 participants
|
|
Antiepileptic Drugs Used in the Past
Tiagabine
|
4 participants
|
|
Antiepileptic Drugs Used in the Past
Topiramate
|
40 participants
|
|
Antiepileptic Drugs Used in the Past
Valproate
|
97 participants
|
|
Antiepileptic Drugs Used in the Past
Vigabatrine
|
4 participants
|
|
Antiepileptic Drugs Used in the Past
Other
|
16 participants
|
|
Antiepileptic Drugs Used in the Past
Missing
|
9 participants
|
|
Antiepileptic Drugs Used in the Past
No previous treatment
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 16 (Final Visit )Population: FAS. Subjects who discontinued less than 4 weeks into the treatment period or with missing date of the attack were excluded from analyses.
Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase \* 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase \* 28 divided by total number of days in maintenance treatment phase.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=196 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Change in 28 Day Partial Seizure Frequency
Baseline Period
|
3.20 number of seizures per 28 days
Standard Deviation 3.375
|
|
Change in 28 Day Partial Seizure Frequency
Treatment Period
|
1.339 number of seizures per 28 days
Standard Deviation 2.5177
|
|
Change in 28 Day Partial Seizure Frequency
Change from Baseline to Treatment Period
|
-1.860 number of seizures per 28 days
Standard Deviation 2.0494
|
SECONDARY outcome
Timeframe: Week 8 up to Week 16 (Last 4 weeks of the treatment period)Population: FAS
Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study
Responders: Seizure-free
|
119 participants
|
|
Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study
Non-responders: With Seizures
|
77 participants
|
|
Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study
Missing
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 16 (Final Visit)Population: Safety analysis set.
Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Concomitant Drug Treatments
Acetylsalicylic acid
|
2 participants
|
|
Concomitant Drug Treatments
Acidum folicum
|
1 participants
|
|
Concomitant Drug Treatments
Alendronic acid
|
1 participants
|
|
Concomitant Drug Treatments
Alprazolam
|
2 participants
|
|
Concomitant Drug Treatments
Amlodipine besilate
|
1 participants
|
|
Concomitant Drug Treatments
Amlozek
|
1 participants
|
|
Concomitant Drug Treatments
Anopyrin
|
3 participants
|
|
Concomitant Drug Treatments
Atorvastatin calcium
|
1 participants
|
|
Concomitant Drug Treatments
Aurorix
|
1 participants
|
|
Concomitant Drug Treatments
Biston
|
1 participants
|
|
Concomitant Drug Treatments
Carbamazepine
|
26 participants
|
|
Concomitant Drug Treatments
Cipralex
|
1 participants
|
|
Concomitant Drug Treatments
Citalopram
|
2 participants
|
|
Concomitant Drug Treatments
Citalopram hydrobromide
|
1 participants
|
|
Concomitant Drug Treatments
Clonazepam
|
6 participants
|
|
Concomitant Drug Treatments
Colecalciferol
|
1 participants
|
|
Concomitant Drug Treatments
Depakine
|
10 participants
|
|
Concomitant Drug Treatments
Depakine chrono
|
14 participants
|
|
Concomitant Drug Treatments
Detralex
|
1 participants
|
|
Concomitant Drug Treatments
Diarel
|
1 participants
|
|
Concomitant Drug Treatments
Diazepam
|
1 participants
|
|
Concomitant Drug Treatments
Dipyridamole
|
1 participants
|
|
Concomitant Drug Treatments
Enelbin - slow release
|
1 participants
|
|
Concomitant Drug Treatments
Euthyrox
|
2 participants
|
|
Concomitant Drug Treatments
Felodipine/ramipril
|
1 participants
|
|
Concomitant Drug Treatments
Fenytoin
|
1 participants
|
|
Concomitant Drug Treatments
Fluanxol depot
|
1 participants
|
|
Concomitant Drug Treatments
Gabapentin
|
3 participants
|
|
Concomitant Drug Treatments
Gabitril
|
1 participants
|
|
Concomitant Drug Treatments
Geratam
|
1 participants
|
|
Concomitant Drug Treatments
Ginko biloba
|
1 participants
|
|
Concomitant Drug Treatments
Glibenclamide
|
1 participants
|
|
Concomitant Drug Treatments
Glucobene
|
1 participants
|
|
Concomitant Drug Treatments
Godasal
|
2 participants
|
|
Concomitant Drug Treatments
Hypnogen
|
1 participants
|
|
Concomitant Drug Treatments
Keppra
|
20 participants
|
|
Concomitant Drug Treatments
Lamictal
|
18 participants
|
|
Concomitant Drug Treatments
Lamotrigine
|
49 participants
|
|
Concomitant Drug Treatments
Letrox
|
2 participants
|
|
Concomitant Drug Treatments
Levetiracetam
|
20 participants
|
|
Concomitant Drug Treatments
Levothyroxine
|
2 participants
|
|
Concomitant Drug Treatments
Lexaurin
|
1 participants
|
|
Concomitant Drug Treatments
Lipanthyl
|
2 participants
|
|
Concomitant Drug Treatments
Lispril
|
1 participants
|
|
Concomitant Drug Treatments
Liskantin
|
4 participants
|
|
Concomitant Drug Treatments
Lokren
|
1 participants
|
|
Concomitant Drug Treatments
Lusopress
|
1 participants
|
|
Concomitant Drug Treatments
Magnesium
|
1 participants
|
|
Concomitant Drug Treatments
Magnesium lactate
|
2 participants
|
|
Concomitant Drug Treatments
Metformin
|
1 participants
|
|
Concomitant Drug Treatments
Metoprolol
|
1 participants
|
|
Concomitant Drug Treatments
Micardis
|
2 participants
|
|
Concomitant Drug Treatments
Neurontin
|
1 participants
|
|
Concomitant Drug Treatments
Neurotop
|
3 participants
|
|
Concomitant Drug Treatments
Neurotop - slow release
|
5 participants
|
|
Concomitant Drug Treatments
Omeprazol
|
1 participants
|
|
Concomitant Drug Treatments
Omeprazole
|
1 participants
|
|
Concomitant Drug Treatments
Paroxetine
|
1 participants
|
|
Concomitant Drug Treatments
Pentomer
|
1 participants
|
|
Concomitant Drug Treatments
Perindopril
|
1 participants
|
|
Concomitant Drug Treatments
Perindopril erbumine
|
1 participants
|
|
Concomitant Drug Treatments
Phenytoin
|
4 participants
|
|
Concomitant Drug Treatments
Piracetam
|
2 participants
|
|
Concomitant Drug Treatments
Prestarium
|
5 participants
|
|
Concomitant Drug Treatments
Primdone
|
2 participants
|
|
Concomitant Drug Treatments
Ramipril
|
1 participants
|
|
Concomitant Drug Treatments
Ramipril/hydrochlorothiazide
|
1 participants
|
|
Concomitant Drug Treatments
Rivotril
|
8 participants
|
|
Concomitant Drug Treatments
Rufinamide
|
1 participants
|
|
Concomitant Drug Treatments
Sabril
|
1 participants
|
|
Concomitant Drug Treatments
Sanepil
|
1 participants
|
|
Concomitant Drug Treatments
Seretide diskus
|
1 participants
|
|
Concomitant Drug Treatments
Sertraline
|
1 participants
|
|
Concomitant Drug Treatments
Simepar
|
1 participants
|
|
Concomitant Drug Treatments
Simvastatin
|
1 participants
|
|
Concomitant Drug Treatments
Siofor
|
1 participants
|
|
Concomitant Drug Treatments
Sodanton
|
1 participants
|
|
Concomitant Drug Treatments
Sorbimon
|
1 participants
|
|
Concomitant Drug Treatments
Sumatriptan
|
1 participants
|
|
Concomitant Drug Treatments
Symbicort turbuhaler "Draco"
|
1 participants
|
|
Concomitant Drug Treatments
Tegretol
|
2 participants
|
|
Concomitant Drug Treatments
Tegretol CR
|
8 participants
|
|
Concomitant Drug Treatments
Ticlopidine
|
3 participants
|
|
Concomitant Drug Treatments
Timonil
|
1 participants
|
|
Concomitant Drug Treatments
Timonil - slow release
|
8 participants
|
|
Concomitant Drug Treatments
Topamax
|
15 participants
|
|
Concomitant Drug Treatments
Topiramate
|
25 participants
|
|
Concomitant Drug Treatments
Trandlapril
|
1 participants
|
|
Concomitant Drug Treatments
Valproate
|
22 participants
|
|
Concomitant Drug Treatments
Valproate sodium
|
7 participants
|
|
Concomitant Drug Treatments
Valproic acid
|
14 participants
|
|
Concomitant Drug Treatments
Vasocardin
|
1 participants
|
|
Concomitant Drug Treatments
Vinpocetine
|
1 participants
|
|
Concomitant Drug Treatments
Warfarin
|
1 participants
|
|
Concomitant Drug Treatments
Zocor
|
2 participants
|
|
Concomitant Drug Treatments
Zoloft
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16 (Final Visit )Population: Safety analysis set.
Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline: 75 mg
|
31 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline:100 mg
|
0 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline: 130 mg
|
1 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline: 150 mg
|
166 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline: 225 mg
|
0 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline: 300 mg
|
1 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline: 375 mg
|
0 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline: 450 mg
|
0 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline: 525 mg
|
0 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Baseline: 600 mg
|
0 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 75 mg
|
8 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 100 mg
|
1 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 130 mg
|
1 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 150 mg
|
55 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 225 mg
|
5 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 300 mg
|
89 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 375 mg
|
1 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 450 mg
|
6 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 525 mg
|
1 participants
|
|
Average Dosage of Pregabalin Taken at Baseline and Final Visit
Final Visit: 600 mg
|
32 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried ForwardPopulation: FAS; Last observation carried forward (LOCF) method: subject's last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.
Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Visual Analog Scale of Anxiety (VAS-A)
Baseline (n=197)
|
47.1 mm
Standard Deviation 21.52
|
|
Visual Analog Scale of Anxiety (VAS-A)
Week 4 (Visit 2 ) (n=196)
|
36.7 mm
Standard Deviation 18.43
|
|
Visual Analog Scale of Anxiety (VAS-A)
Week 16 (Final Visit ) (n=197)
|
29.0 mm
Standard Deviation 17.05
|
|
Visual Analog Scale of Anxiety (VAS-A)
Last Observation Carried Forward (LOCF) (n=198)
|
29.0 mm
Standard Deviation 17.03
|
SECONDARY outcome
Timeframe: Baseline, Week 16 (Final Visit), Last Observation Carried ForwardPopulation: FAS; Last observation carried forward (LOCF) method: subject's last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.
Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)
Change from Baseline to Week 16 (n=196)
|
-18.2 mm
Standard Deviation 17.61
|
|
Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)
Change from Baseline to LOCF (n=197)
|
-18.1 mm
Standard Deviation 17.64
|
SECONDARY outcome
Timeframe: BaselinePopulation: FAS
CGI-S scale: physician's global impression of a subject's clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Normal, not at all ill
|
28 participants
|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Borderline mentally ill
|
77 participants
|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Mildly ill
|
39 participants
|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Moderately ill
|
31 participants
|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Markedly ill
|
14 participants
|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Severely ill
|
9 participants
|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Among the most extremely ill patients
|
1 participants
|
SECONDARY outcome
Timeframe: Week 16 (Final Visit)Population: FAS
CGI-C scale: physician's global impression of a subject's clinical condition in terms of change from baseline. 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.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)
Improvement
|
174 participants
|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)
No Change
|
21 participants
|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)
Worsening
|
2 participants
|
|
Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)
Missing
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16 (Final Visit )Population: FAS. A subscale was classified as missing if any of the questions used in the calculation were missing. Abbreviations: BL = Baseline, SOB = short of breath.
MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Medical Outcomes Sleep Scale (MOS-S)
Baseline: Sleep Disturbance
|
37.86 scores on scales
Standard Deviation 20.643
|
|
Medical Outcomes Sleep Scale (MOS-S)
Baseline: Snoring
|
29.1 scores on scales
Standard Deviation 21.31
|
|
Medical Outcomes Sleep Scale (MOS-S)
Baseline: Awaken Short of Breath or With Headache
|
18.5 scores on scales
Standard Deviation 19.26
|
|
Medical Outcomes Sleep Scale (MOS-S)
Baseline: Quantity of Sleep
|
7.0 scores on scales
Standard Deviation 1.40
|
|
Medical Outcomes Sleep Scale (MOS-S)
Baseline: Sleep Adequacy
|
47.51 scores on scales
Standard Deviation 24.336
|
|
Medical Outcomes Sleep Scale (MOS-S)
Baseline: Somnolence
|
35.99 scores on scales
Standard Deviation 16.197
|
|
Medical Outcomes Sleep Scale (MOS-S)
Baseline: Sleep 6-Item Index
|
38.74 scores on scales
Standard Deviation 17.522
|
|
Medical Outcomes Sleep Scale (MOS-S)
Baseline: Sleep 9-Item Index
|
38.82 scores on scales
Standard Deviation 16.840
|
|
Medical Outcomes Sleep Scale (MOS-S)
Final Visit: Sleep Disturbance
|
25.21 scores on scales
Standard Deviation 15.670
|
|
Medical Outcomes Sleep Scale (MOS-S)
Final Visit: Snoring
|
26.5 scores on scales
Standard Deviation 21.86
|
|
Medical Outcomes Sleep Scale (MOS-S)
Final Vst: Awaken Short of Breath or With Headache
|
15.1 scores on scales
Standard Deviation 16.68
|
|
Medical Outcomes Sleep Scale (MOS-S)
Final Visit: Quantity of Sleep
|
7.5 scores on scales
Standard Deviation 1.31
|
|
Medical Outcomes Sleep Scale (MOS-S)
Final Visit: Sleep Adequacy
|
60.00 scores on scales
Standard Deviation 22.113
|
|
Medical Outcomes Sleep Scale (MOS-S)
Final Visit: Somnolence
|
30.09 scores on scales
Standard Deviation 15.398
|
|
Medical Outcomes Sleep Scale (MOS-S)
Final Visit: Sleep 6-Item Index
|
29.30 scores on scales
Standard Deviation 14.501
|
|
Medical Outcomes Sleep Scale (MOS-S)
Final Visit: Sleep 9-Item Index
|
28.69 scores on scales
Standard Deviation 13.399
|
|
Medical Outcomes Sleep Scale (MOS-S)
Change from BL: Sleep Disturbance
|
-13.07 scores on scales
Standard Deviation 17.010
|
|
Medical Outcomes Sleep Scale (MOS-S)
Change from BL: Snoring
|
-2.9 scores on scales
Standard Deviation 13.01
|
|
Medical Outcomes Sleep Scale (MOS-S)
Change from BL: Awaken SOB or Headache
|
-3.8 scores on scales
Standard Deviation 13.55
|
|
Medical Outcomes Sleep Scale (MOS-S)
Change from BL: Quantity of Sleep
|
0.6 scores on scales
Standard Deviation 1.23
|
|
Medical Outcomes Sleep Scale (MOS-S)
Change from BL: Sleep Adequacy
|
13.02 scores on scales
Standard Deviation 19.636
|
|
Medical Outcomes Sleep Scale (MOS-S)
Change from BL: Somnolence
|
-6.18 scores on scales
Standard Deviation 14.399
|
|
Medical Outcomes Sleep Scale (MOS-S)
Change from BL: Sleep 6-Item Index
|
-9.88 scores on scales
Standard Deviation 13.641
|
|
Medical Outcomes Sleep Scale (MOS-S)
Change from BL: Sleep 9-Item Index
|
-10.54 scores on scales
Standard Deviation 13.280
|
SECONDARY outcome
Timeframe: Baseline, Week 16 (Final Visit)Population: FAS. Abbreviations: BL = Baseline; FV = Final Visit.
MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (\<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.
Outcome measures
| Measure |
Pregabalin (Lyrica)
n=199 Participants
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
BL: Optimal Sleep; FV: Optimal Sleep
|
82 participants
|
|
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
BL: Optimal Sleep; FV: Non-Optimal Sleep
|
10 participants
|
|
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
BL: Optimal Sleep; FV: Missing
|
2 participants
|
|
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
BL: Non-Optimal Sleep; FV: Optimal Sleep
|
33 participants
|
|
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
BL: Non-Optimal Sleep; FV: Non-Optimal Sleep
|
48 participants
|
|
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
BL: Non-Optimal Sleep; FV: Missing
|
5 participants
|
|
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
BL: Missing; FV: Optimal Sleep
|
1 participants
|
|
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
BL: Missing; FV: Non-Optimal Sleep
|
2 participants
|
|
Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
BL: Missing; FV: Missing
|
16 participants
|
Adverse Events
Pregabalin (Lyrica)
Serious adverse events
| Measure |
Pregabalin (Lyrica)
n=199 participants at risk
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Nervous system disorders
Hemiplegia
|
0.50%
1/199
|
Other adverse events
| Measure |
Pregabalin (Lyrica)
n=199 participants at risk
Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
2/199
|
|
General disorders
Oedema peripheral
|
0.50%
1/199
|
|
Investigations
Weight increased
|
3.0%
6/199
|
|
Nervous system disorders
Dizziness
|
5.0%
10/199
|
|
Nervous system disorders
Epilepsy
|
0.50%
1/199
|
|
Nervous system disorders
Somnolence
|
3.0%
6/199
|
|
Psychiatric disorders
Anxiety
|
0.50%
1/199
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER