Restless Legs SyndromePhase 3NCT01061372
12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
A Phase 3 study testing pregabalin in people with Restless Legs Syndrome, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Aug 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any secondary RLS
- Current augmentation due to RLS treatment
- Placebo responders identified during the placebo run-in
About this study
Official title: Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
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.
- Conditions
- Restless Legs Syndrome
- Being tested
- Placebo, pregabalin
- Keywords
- RLS
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
pregabalinDrug
Also called Lyrica
pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
pregabalinDrug
Also called Lyrica
pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Pregabalin 150 mg/day | Experimental | Not described Receives: Drug: pregabalin |
| Pregabalin 300 mg/day | Experimental | Not described Receives: Drug: pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment
Measured: up to 12 weeks
The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment
Measured: up to 12 weeks
Secondary outcomes (13)
Subjective Sleep Questionnaire (SSQ - Subjective WASO)
Measured: up to 12 weeks
RLS Next Day Impact (RLS-NDI)
Measured: up to 12 weeks
Limb pain rating using a numerical rating scale (Limb Pain - NRS)
Measured: up to 12 weeks
Clinical Global Impressions - Severity (CGI-S)
Measured: up to 12 weeks
Medical Outcomes Study - Sleep Scale (MOS - SS)
Measured: up to 12 weeks
Impact on Life (IRLS symptom impact sub-score)
Measured: up to 12 weeks
RLS-Quality of Life Scale (RLS-QoL)
Measured: up to 12 weeks
Medical Outcomes Study - Short Form 36 (SF-36)
Measured: up to 12 weeks
Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP)
Measured: up to 12 weeks
Profile of Mood States (POMS)
Measured: up to 12 weeks
Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group
Measured: up to 12 weeks
Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide
Measured: 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
Measured: week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061372
- Sponsor's protocol ID
- A0081184
- Status last verified
- Jun 2010
- First submitted
- 1 Feb 2010
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT01061372
- Acronym / sponsor ID
- A0081184
- Conditions
- Restless Legs Syndrome
- Keywords
- RLS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Pregabalin 150 mg/day | Experimental | Drug: pregabalin |
| Pregabalin 300 mg/day | Experimental | Drug: pregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Any secondary RLS
- Current augmentation due to RLS treatment
- Placebo responders identified during the placebo run-in
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks | Drug | Placebo |
| pregabalinAlso: Lyricapregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks | Drug | Pregabalin 150 mg/day |
| pregabalinAlso: Lyricapregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks | Drug | Pregabalin 300 mg/day |
Primary outcome
Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment
Time frame: up to 12 weeks
The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment
Time frame: up to 12 weeks
13 secondary outcomes
Subjective Sleep Questionnaire (SSQ - Subjective WASO)
Time frame: up to 12 weeks
RLS Next Day Impact (RLS-NDI)
Time frame: up to 12 weeks
Limb pain rating using a numerical rating scale (Limb Pain - NRS)
Time frame: up to 12 weeks
Clinical Global Impressions - Severity (CGI-S)
Time frame: up to 12 weeks
Medical Outcomes Study - Sleep Scale (MOS - SS)
Time frame: up to 12 weeks
Impact on Life (IRLS symptom impact sub-score)
Time frame: up to 12 weeks
RLS-Quality of Life Scale (RLS-QoL)
Time frame: up to 12 weeks
Medical Outcomes Study - Short Form 36 (SF-36)
Time frame: up to 12 weeks
Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP)
Time frame: up to 12 weeks
Profile of Mood States (POMS)
Time frame: up to 12 weeks
Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group
Time frame: up to 12 weeks
Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide
Time frame: 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
Time frame: week 13
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pregabalin in people with Restless Legs Syndrome, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.