Phase 3
N=119
Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
Fibromyalgia · Sleep Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00883740 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Wake After Sleep Onset (WASO) at Weeks 5 and 11 — 70.69; 51.54 Minutes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wake After Sleep Onset (WASO) at Weeks 5 and 11 |
70.69; 51.54 | <0.0001 sig |
| SECONDARY Wake Time During Sleep (WTDS) |
63.38; 45.83 | <0.0001 sig |
| SECONDARY Wake Time After Sleep (WTAS) |
9.19; 7.38 | 0.3841 |
| SECONDARY Total Sleep Time (TST) |
370.6; 396.2 | <0.0001 sig |
| SECONDARY Sleep Efficiency (SE) |
77.21; 82.64 | <0.0001 sig |
| SECONDARY Number of Awakenings After Sleep Onset (NAASO 1) |
26.92; 24.51 | 0.0135 sig |
| SECONDARY Number of Awakenings After Sleep Onset (NAASO 2) |
10.16; 8.63 | 0.0008 sig |
| SECONDARY Latency to Persistent Sleep (LPS) |
41.63; 34.45 | 0.0447 sig |
| SECONDARY WASO by Hour of the Night |
1.96; 1.62; 5.66; 4.56; 7.09; 4.65 | 0.3613 |
| SECONDARY WASO by Each Quarter of the Night |
7.23; 5.98; 16.04; 10.04; 21.73; 14.90 | 0.1106 |
| SECONDARY Slow Wave Sleep (SWS) |
15.04; 17.18 | 0.0024 sig |
| SECONDARY Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11 |
-19.0; -27.1; -2.23; -21.0 | 0.0591 |
| SECONDARY Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11 |
-16.4; -21.9; -0.98; -14.4 | 0.1101 |
| SECONDARY Sleep Quality |
4.79; 5.70; 4.95; 6.09; 5.09; 5.96 | <0.0001 sig |
| SECONDARY Latency of Sleep Onset (LSO) |
51.23; 43.56; 49.94; 42.27; 48.92; 43.24 | 0.0001 sig |
| SECONDARY Daily Pain Score |
6.12; 5.42; 5.81; 5.10; 5.73; 5.14 | <0.0001 sig |
| SECONDARY Subjective Wake After Sleep Onset (sWASO) |
80.86; 62.59; 75.48; 59.43; 74.97; 61.73 | <0.0001 sig |
| SECONDARY Subjective Total Sleep Time (sTST) |
336.8; 361.7; 341.9; 371.3; 344.1; 370.9 | <0.0001 sig |
Summary
The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)
Eligibility Criteria
Inclusion Criteria
- Subjects must meet diagnostic criteria for fibromyalgia;
- Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.
Exclusion Criteria
- History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;
- Use of medications known to affect sleep wake function by Visit 2;
- Involved in night or rotating shift work, or travel across >4 time zones 14 days prior to screening and during study; regular daytime napping
- PSG finding of apnea/hypopnea or periodic limb movement with arousal index >10/hr on either night of PSG.
Data sourced from ClinicalTrials.gov (NCT00883740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.