Phase 3
N=731
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
Idiopathic Restless Legs Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00806026 ↗Enrolled (actual)
731
Serious AEs
5.1%
Results posted
Sep 2012
Primary outcome: Primary: Restless Legs Syndrome (RLS) Symptom Severity — 22.30; 22.40; 22.10; 22.40 Units on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- placebo and pregabalin (Drug); pramipexol (Drug); Pregabalin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Restless Legs Syndrome (RLS) Symptom Severity |
22.30; 22.40; 22.10; 22.40 | — |
| PRIMARY Change From Baseline in the RLS Symptom Severity at Week 12 |
-11.80; -7.90; -10.50; -7.30 | <0.0001 sig |
| PRIMARY Percentage of Participants Responding to Treatment at Week 12 |
71.40; 51.20; 62.70; 46.80 | <0.0001 sig |
| PRIMARY Percentage of Participants With Augmentation |
1.70; 6.60; 9.00 | 0.0826 |
| SECONDARY Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO) |
90.60; 100.20; 83.90; 79.50 | — |
| SECONDARY Change From Baseline in SSQ: Subjective WASO at Week 12 |
-49.86; -33.69; -37.18; -32.61 | <0.0001 sig |
| SECONDARY Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12 |
41.60; 43.10; 35.90; 47.70 | — |
| SECONDARY Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12 |
7.00; 6.70; 6.80; 6.70 | — |
| SECONDARY Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12 |
1.10; 1.70; 1.50; 1.80 | — |
| SECONDARY Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12 |
66.50; 57.40; 60.20; 57.70 | — |
| SECONDARY RLS-Next Day Impact (RLS-NDI) |
49.30; 51.90; 58.40; 50.00 | — |
| SECONDARY Change From Baseline in RLS-NDI at Week 12 |
-8.10; -4.30; -14.50; -6.60 | 0.7073 |
| SECONDARY Limb Pain-Visual Analog Scale (Limb Pain-VAS) |
4.20; 4.30; 4.00; 4.10 | — |
| SECONDARY Change From Baseline in Limb Pain-VAS at Week 12 |
-3.20; -2.64; -2.75; -2.20 | 0.0004 sig |
| SECONDARY Severity of Augmentation Symptoms at Week 12 |
0.90; 1.60; 1.30; 1.40 | — |
| SECONDARY Clinical Global Impressions-Severity (CGI-S) at Week 12 |
2.90; 3.50; 3.10; 3.70 | — |
| SECONDARY Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12 |
30.50; 39.30; 34.40; 38.60; 29.00; 25.80 | — |
| SECONDARY Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12 |
84; 64; 77; 68 | — |
| SECONDARY Profile of Mood State (POMS) at Week 12 |
— | — |
| SECONDARY Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12 |
77.75; 73.33; 75.48; 73.23 | — |
| SECONDARY Medical Outcomes Study-Short Form 36 (SF-36) at Week 12 |
83.70; 81.90; 82.40; 83.00; 81.20; 79.60 | — |
| SECONDARY Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12 |
6.00; 5.70; 9.10; 14.60; 12.20; 20.90 | — |
Summary
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
Eligibility Criteria
Inclusion Criteria
- idiopathic RLS with the presence of all four clinical manifestations of RLS
- RLS symptoms occur predominantly in the evening
- RLS history at least 6 months
- IRLS => 15 at the beginning and the end of placebo run-in
- Have =>15 nights with RLS symptoms in the month prior to screening
Exclusion Criteria
- Any secondary RLS
- Current augmentation due to RLS treatment
- Placebo responders identified during the placebo run-in
Data sourced from ClinicalTrials.gov (NCT00806026). 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.