Restless Legs Syndrome
Conditions
Keywords
RLS
Brief summary
The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.
Interventions
DRUGPlacebo
Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
DRUGpregabalin
pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS: * RLS symptoms occur predominantly in the evening * RLS history at least 6 months * International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in * Have greater than or equal to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment | up to 12 weeks |
| The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment | up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Limb pain rating using a numerical rating scale (Limb Pain - NRS) | up to 12 weeks |
| Clinical Global Impressions - Severity (CGI-S) | up to 12 weeks |
| Medical Outcomes Study - Sleep Scale (MOS - SS) | up to 12 weeks |
| Impact on Life (IRLS symptom impact sub-score) | up to 12 weeks |
| RLS-Quality of Life Scale (RLS-QoL) | up to 12 weeks |
| Subjective Sleep Questionnaire (SSQ - Subjective WASO) | up to 12 weeks |
| Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) | up to 12 weeks |
| Profile of Mood States (POMS) | up to 12 weeks |
| Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group | up to 12 weeks |
| Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide | up to 12 weeks |
| Changes in RLS symptoms following the discontinuation of study drug at the end of treatment will be evaluated by collection of the IRLS scores at the end of the drug taper period at Week 13 | week 13 |
| Medical Outcomes Study - Short Form 36 (SF-36) | up to 12 weeks |
| RLS Next Day Impact (RLS-NDI) | up to 12 weeks |
Outcome results
None listed