Trial · NCT02397057
Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
NCT02397057, Phase 3, Completed, American Regent, Inc.; results first posted 2021-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS. Trials, record NCT02397057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02397057
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
- NCT number
- NCT02397057
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 209 participants, actual
- Lead sponsor
- American Regent, Inc.
- Conditions
- Restless Legs Syndrome (RLS)
- Interventions
- Injectafer, Placebo
- First posted
- 2015-03-24
- Last updated
- 2021-10-12
- Results first posted
- 2021-10-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42 | Baseline and Day 42 | Summary of the actual values of IRLS total score on baseline and Day 42, and the change from baseline to Day 42. Eligible subjects were to have met the following requirements prior to receiving additional treatment: A baseline score ≥ 15 on the International Restless Legs Syndrome (IRLS) Rating Scale. The minimum score is 15 with the maximum of 40. A score of less than 15 is not an indicator of RLS. However, a score of 15 or greater is an indicator of RLS. Further increase indicates more severe disease. |
| Primary | Proportion of Patients Rated as Much or Very Much Improved With the Clinical Global Impression (CGI) Performed by Investigator (CGI-I) | Day 42 | Responder is defined as subjects rated as much or very much improved with the CGI-I on Day 42. Summary of the number (percentage) of CGI-I responder. Per the protocol, the he CGI is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response. The scale requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. |
| Secondary | Clinical Global Impression-Improvement (CGI-S) by Subject | Day 42 | Similar to the CGI-I except this is self-reported, 7-item scale for assessment of symptoms after treatment with the rating as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. |
| Secondary | Restless Legs Syndrome Quality of Life (RLS-QLI) Change From Baseline to Day 42. | Baseline and Day 42 | The Restless Legs Syndrome Quality of Life (RLS-QLI) instrument, a self-assessment, 17-item questionnaire with four scales identified through factor analysis: Daily Function, Social Function, Sleep Quality, and Emotional Well-Being, developed to facilitate clinical research on RLS. Scoring Instructions below: 1. Social Function = Sum (Items 1, 2, 3, 4), subtract 4, divide by 16, multiply by 100 2. Daily Function = Sum (Items 5, 6, 13,14, 15, 16), subtract 6, divide by 24, multiply by 100 3. Sleep Quality = Sum (Item 7, 8, 9, 17), subtract 4, divide by 18, multiply by 100 4. Emotional Well-being = Sum (Items 10, 11, 12), subtract 3, divide by 12, multiply by 100 Note: Resulting scores range between 0-100. Higher scores on the RLS-QLI indicate a lower quality of life. Lower scores indicate a higher quality of life. |
| Secondary | Fatigue Linear Analog Scale Change From Baseline | Baseline and Day 42 | The Fatigue Linear Analog Scale is a self-assessment scale in which a 100 mm line is used to measure the severity of fatigue and its effect on a person's activities and lifestyle. The scale severity measure ranges from No Fatigue to Worst Possible Fatigue. |
| Secondary | Medical Outcomes Study(MOS) Sleep Scale Change From Baseline to Day 42 | Change from Baseline and Day 42. | The MOS-Sleep scale, is a 12-item standardized, validated questionnaire for assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache which has been demonstrated to be sensitive to RLS treatment effects. This questionnaire provides information about sleep quality. Individual questions can be used for analysis but summary or index scores of a group of questions, is more commonly used in analysis. The "quantity of sleep" dimension is the average number of hours of sleep per night reported by the patient and the "optimal sleep" is a dichotomized version that is "yes" when the number of hours of sleep is 7 or 8. The scores of the dimensions and of the sleep problem index were converted to a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater adequacy of sleep). |
| Secondary | Time Off Pre-Enrollment Prescribed Restless Legs Syndrome (RLS) Medications | Time from Day 5 to Day 365 | Subjects could start tapering off pre-enrollment prescribed RLS medications after Day 5 until Day 365. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42 | Baseline and Day 42 | One subject did not receive study drug and was excluded from the safety and Full analysis set population. | score on a scale | MEAN |
| PRIMARY | Proportion of Patients Rated as Much or Very Much Improved With the Clinical Global Impression (CGI) Performed by Investigator (CGI-I) | Day 42 | Responder(a), n/m(b) : a : Responder was defined as subjects rated as much or very much improved with the CGI-I.~b : n is the number of responders; m is number of subjects who had non-missing results at the visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Global Impression-Improvement (CGI-S) by Subject | Day 42 | Observed cases (n/m(a) \[%\])~a: n is the number of subjects of the category, m is number of subjects who have non-missing results at the visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Restless Legs Syndrome Quality of Life (RLS-QLI) Change From Baseline to Day 42. | Baseline and Day 42 | One subject did not receive study drug and was excluded from the Safety and Full Analysis Set Populations. | units on a scale | MEAN |
| SECONDARY | Fatigue Linear Analog Scale Change From Baseline | Baseline and Day 42 | One subject did not receive study drug and was excluded from the Safety and Full Analysis Set Populations. | units on a scale | MEAN |
| SECONDARY | Medical Outcomes Study(MOS) Sleep Scale Change From Baseline to Day 42 | Change from Baseline and Day 42. | Only participants with Sleep disturbance are included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time Off Pre-Enrollment Prescribed Restless Legs Syndrome (RLS) Medications | Time from Day 5 to Day 365 | Full Analysis Set Population. Subjects who discontinued or completed the study before an intervention were censored at the last study visit.~Subjects Receiving RLS Intervention after Day 5. | days | MEAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42 | Injectafer | Baseline | 24.1 | Standard Deviation 6.27 | score on a scale |
| International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42 | Normal Saline | Baseline | 24.5 | Standard Deviation 6.05 | score on a scale |
| International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42 | Injectafer | Day 42 | 15.6 | Standard Deviation 8.69 | score on a scale |
| International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42 | Normal Saline | Day 42 | 18.7 | Standard Deviation 8.94 | score on a scale |
| International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42 | Injectafer | Change from Baseline to Day 42 | -8.7 | Standard Deviation 8.44 | score on a scale |
| International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42 | Normal Saline | Change from Baseline to Day 42 | -5.9 | Standard Deviation 9.07 | score on a scale |
| Proportion of Patients Rated as Much or Very Much Improved With the Clinical Global Impression (CGI) Performed by Investigator (CGI-I) | Injectafer | 38 | Participants | ||
| Proportion of Patients Rated as Much or Very Much Improved With the Clinical Global Impression (CGI) Performed by Investigator (CGI-I) | Normal Saline | 25 | Participants | ||
| Clinical Global Impression-Improvement (CGI-S) by Subject | Injectafer | Very much improved | 10 | Participants | |
| Clinical Global Impression-Improvement (CGI-S) by Subject | Normal Saline | Very much improved | 7 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Injectafer | 105 | |
| Overall Study | STARTED | Normal Saline | 104 | |
| Overall Study | COMPLETED | Injectafer | 94 | |
| Overall Study | COMPLETED | Normal Saline | 91 | |
| Overall Study | NOT COMPLETED | Injectafer | 11 | |
| Overall Study | NOT COMPLETED | Normal Saline | 13 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Injectafer | 10 | 107 | 12 |
| other | Nausea | Gastrointestinal disorders | Normal Saline | 1 | 101 | 1 |
| other | Feeling hot | General disorders | Injectafer | 6 | 107 | 6 |
| other | Feeling hot | General disorders | Normal Saline | 0 | 101 | 0 |
| other | Blood pressure increased | Investigations | Injectafer | 5 | 107 | 5 |
| other | Blood pressure increased | Investigations | Normal Saline | 1 | 101 | 1 |
| other | Alanine aminotransferase increased | Investigations | Injectafer | 5 | 107 | 5 |
| other | Alanine aminotransferase increased | Investigations | Normal Saline | 1 | 101 | 1 |
| other | Blood phosphorus decreased | Investigations | Injectafer | 3 | 107 | 3 |
| other | Blood phosphorus decreased | Investigations | Normal Saline | 0 | 101 | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Injectafer | 1 | 107 |
| Total, all-cause mortality | Normal Saline | 0 | 101 |
| Total, other adverse events | Injectafer | 72 | 107 |
| Total, other adverse events | Normal Saline | 19 | 101 |
| Total, serious adverse events | Injectafer | 6 | 107 |
| Total, serious adverse events | Normal Saline | 4 | 101 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38625730 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Injectafer vs Normal Saline: Proportion of Patients Rated as Much or Very Much Improved With the Clinical Global Impression (CGI) Performed by Investigator (CGI-I) | Trial comparisons |
| Injectafer vs Normal Saline: deaths from any cause | Trial comparisons |
| Injectafer vs Normal Saline: serious adverse events | Trial comparisons |
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/NCT02397057
GET https://conductscience.org/api/trials/v1/NCT02397057/results?page=2