Trial · NCT01061372
12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
NCT01061372, Phase 3, Withdrawn, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects. Trials, record NCT01061372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01061372
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
- NCT number
- NCT01061372
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Restless Legs Syndrome
- Interventions
- Placebo, pregabalin, pregabalin
- First posted
- 2010-02-03
- Last updated
- 2021-01-22
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | |
| Primary | The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment | up to 12 weeks | |
| Secondary | Subjective Sleep Questionnaire (SSQ - Subjective WASO) | up to 12 weeks | |
| Secondary | RLS Next Day Impact (RLS-NDI) | up to 12 weeks | |
| Secondary | Limb pain rating using a numerical rating scale (Limb Pain - NRS) | up to 12 weeks | |
| Secondary | Clinical Global Impressions - Severity (CGI-S) | up to 12 weeks | |
| Secondary | Medical Outcomes Study - Sleep Scale (MOS - SS) | up to 12 weeks | |
| Secondary | Impact on Life (IRLS symptom impact sub-score) | up to 12 weeks | |
| Secondary | RLS-Quality of Life Scale (RLS-QoL) | up to 12 weeks | |
| Secondary | Medical Outcomes Study - Short Form 36 (SF-36) | up to 12 weeks |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01061372
GET https://conductscience.org/api/trials/v1/NCT01061372/registered