Trial · NCT01061372
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 | |
| Secondary | Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) | up to 12 weeks | |
| Secondary | Profile of Mood States (POMS) | up to 12 weeks | |
| Secondary | Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group | up to 12 weeks | |
| Secondary | Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide | up to 12 weeks | |
| Secondary | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01061372/registered