Phase 3
N=85
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
Restless Legs Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00991276 ↗Enrolled (actual)
85
Serious AEs
2.7%
Results posted
Oct 2012
Primary outcome: Primary: Wake After Sleep Onset (WASO) — 51.50; 78.42; 78.60 minutes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Drug); placebo (Drug); pramipexole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wake After Sleep Onset (WASO) |
51.50; 78.42; 78.60 | <0.0001 sig |
| SECONDARY Periodic Limb Movement Arousal Index (PLMAI) |
3.93; 2.66; 7.61 | <0.0001 sig |
| SECONDARY Subjective Total Sleep Time (sTST) |
400.97; 374.19; 370.16 | <0.0001 sig |
| SECONDARY Minutes of Stage N1, N2, N3 and R Sleep |
38.06; 48.38; 43.72; 227.05; 241.52; 204.35 | 0.0076 sig |
| SECONDARY Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1) |
18.43; 26.30; 21.10 | 0.0077 sig |
| SECONDARY Restless Legs Syndrome-Next Day Impact (RLS-NDI) |
41.43; 46.33; 46.78 | 0.0396 sig |
| SECONDARY Periodic Limb Movement Index (PLMI) |
25.45; 14.11; 39.95 | <0.0001 sig |
| SECONDARY Periodic Limb Movement in Sleep Index (PLMSI) |
22.42; 8.00; 36.95 | <0.0001 sig |
| SECONDARY Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2) |
7.68; 12.39; 10.55 | <0.0001 sig |
| SECONDARY Number of Arousals (NASO) |
17.84; 24.19; 20.29 | 0.0617 |
| SECONDARY Arousal Index (NASOI) |
2.75; 4.18; 3.44 | 0.0056 sig |
| SECONDARY International Restless Legs Syndrome Study Group Rating Scale (IRLS) |
12.28; 15.35; 18.38 | <0.0001 sig |
| SECONDARY Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale |
61.2; 50.0; 33.3 | — |
| SECONDARY Latency to Stage R Sleep (LREM) |
95.22; 130.99; 84.52 | 0.1677 |
| SECONDARY Latency to Persistent Sleep (LPS) |
31.13; 31.52; 38.86 | 0.1040 |
| SECONDARY Wake Time During Sleep (WTDS) |
45.77; 70.51; 69.75 | <0.0001 sig |
| SECONDARY Wake Time After Sleep (WTAS) |
5.58; 7.86; 8.88 | 0.0800 |
| SECONDARY Total Sleep Time (TST) |
402.38; 376.52; 369.66 | <0.0001 sig |
| SECONDARY Sleep Efficiency (SE) |
83.81; 78.58; 77.02 | <0.0001 sig |
| SECONDARY Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO) |
1.62; 2.26; 3.35; 5.04; 7.07; 7.39 | — |
| SECONDARY Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1) |
0.70; 1.39; 1.10; 2.06; 3.32; 2.47 | — |
| SECONDARY Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2) |
0.42; 0.61; 0.73; 1.04; 1.72; 1.37 | — |
| SECONDARY Hourly and Quarterly Assessment of Number of Arousals (NASO) |
1.48; 2.06; 1.79; 2.36; 3.23; 2.68 | — |
| SECONDARY Hourly and Quarterly Assessment of Periodic Limb Movement (PLM) |
31.45; 21.57; 54.67; 26.38; 12.49; 52.93 | — |
| SECONDARY Hourly and Quarterly Assessment of Sleep Efficiency (SE) |
62.31; 66.88; 57.80; 86.13; 83.43; 77.31 | — |
| SECONDARY Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale |
1.69; 2.64; 2.51 | <0.0001 sig |
| SECONDARY Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale |
53.78; 82.23; 79.09 | <0.0001 sig |
| SECONDARY Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale |
6.74; 5.69; 5.70 | <0.0001 sig |
| SECONDARY Subjective Sleep Questionnaire (SSQ): Latency Subscale |
42.49; 40.59; 50.07 | 0.0215 sig |
| SECONDARY Medical Outcomes Study - Sleep Scale (MOS-SS) |
11.59; 13.10; 10.88; 54.96; 43.90; 40.79 | 0.6947 |
| SECONDARY Restless Leg Syndrome - Quality of Life Scale (RLS-QoL) |
73.30; 70.05; 68.03 | 0.0019 sig |
Summary
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of restless legs syndrome with a total score of 15 or more points on the International RLS rating scale (IRLS).
- RLS symptoms interfering with sleep on 3 or more nights per week for at least 6 months.
- PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time of at least 3 hrs and less than 6.5 hrs.
Exclusion Criteria
- Secondary RLS.
- Daytime RLS symptoms requiring treatment.
- Primary sleep disorder.
- Sleep apnea.
- Night or shift work.
- Concurrent medical disorder that could interfere with efficacy assessment or present a safety concern.
- Pregnant or lactating women.
- Women of child-bearing potential not using acceptable method of birth control.
- Use of prohibited medication.
Data sourced from ClinicalTrials.gov (NCT00991276). 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.