Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
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|ClinicalTrials.gov Identifier: NCT02826681|
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : January 27, 2020
Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750 mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency anemia (IDA).
Long-Term Extension Phase III Primary Objective: To evaluate the duration of effect of prior FCM treatment and to determine the effectiveness of further iron repletion with FCM when RLS symptoms worsen or reoccur.
|Condition or disease||Intervention/treatment||Phase|
|Restless Legs Syndrome (RLS)||Drug: Injectafer® (Ferric Carboxymaltose - FCM) Drug: Placebo (Normal Saline)||Phase 2|
This will be a Phase II, randomized, placebo-controlled study. All subjects who meet the inclusion criteria, with no exclusion criteria, will qualify to enter the Screening Phase. The study will enroll 70 eligible subjects to receive blinded study drug in Treatment Phase I. All eligible subjects will be randomized in a 1:1 ratio to receive a blinded dose of either FCM 750 mg undiluted slow intravenous (IV) push at 100 mg/minute or a Placebo (15 ml of Normal Saline [NS]) IV push at 2 ml/minute on Day 0 and 7.
A subject will be defined at Day 42 as a Responder if the International Restless Legs Syndrome Severity Scale (IRLSS) score is ≤10 or if the IRLSS score is >10 with a Clinical Global Impression-Improvement (CGI-I) score of much or very much improvement and the subject does not request further treatment for RLS. A subject will be defined as a treatment Non-Responder if neither of these criteria are met.
Non-Responders who do not meet the laboratory criteria for additional dosing will be discontinued from the study and treated for RLS as deemed appropriate by the referring physician. Subjects who are Non-Responders at the end of Treatment Phase I and met the necessary laboratory criteria (ferritin <300 ng/mL and a TSAT <45%) will consented for enrollment in Treatment Phase II of the study. These subjects will receive the first of two unblinded doses of FCM (undiluted slow IV push 750 mg 100 mg/minute) on Day 0 of Phase II, which will occur within 7 days of the completing Treatment Phase I visit. The subjects will then receive the second dose of FCM (undiluted slow IV push 750 mg 100 mg/minute) on Day 7. All treated subjects will have blood samples taken for hematology, chemistries and iron indices on Day 14. Treatment efficacy (IRLSS score), medication review and adverse events assessment by phone will be done on Day 28. All subjects will return to the clinic on Day 42 for end of study assessments. Subjects completing Treatment Phase II will be re-evaluated on Day 42 and defined as either a Responder or Non-Responder, using the same criteria described above. Subjects deemed as treatment Non-Responders will be discontinued from the study after final assessments are complete.
Subjects who are evaluated on Day 42 (Week 6) as Responders from either Treatment Phase I or Treatment Phase II will continue through into the 46-Week, Long-Term Extension Phase III of the study, and be monitored and assessed by phone for RLS symptoms (IRLSS and Hopkins RLS-Sleep Quality Questionnaire [HRSQ]) and adverse events on (approximately every 9 weeks) Weeks 15, 25, 34, 43 and 52 (final follow-up visit). During Phase III subjects may receive additional unblinded treatments with FCM if at any time the subject reports worsening of RLS symptoms (an increase >4 points on the IRLSS compared to the last evaluation captured for that subject) and laboratory criteria are met (ferritin <300 ng/mL and a TSAT <45%). Subjects will receive a single FCM 750 mg undiluted slow IV push at 100 mg/minute. See section 6.6 for dosing and assessment outline. No additional treatment will be allowed after the Week 46. A final face-to-face study visit will occur on Week 52 (approximately 365 days since initial Day 0 Treatment). If a clinic visit is not possible, final evaluation will be completed by phone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in Restless Legs Syndrome Patients With Iron-deficiency Anemia|
|Actual Study Start Date :||May 24, 2017|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Injectafer
750 mg undiluted slow IVpush (100 mg/minute) of Injectafer® (Ferric Carboxymaltose - FCM)
Drug: Injectafer® (Ferric Carboxymaltose - FCM)
Placebo Comparator: Normal Saline
Placebo (15 ml of Normal Saline [NS]) IV push at 2 ml/minute on Day 0 and 7.
Drug: Placebo (Normal Saline)
Normal Saline Solution
Other Name: Normal Saline
- Treatment Phase I: IRLSS score change [ Time Frame: Baseline to Day 42 ]IRLSS (International Restless Legs Syndrome Severity Scale) score change from baseline to Day 42 with comparison between FCM (Ferric Carboxymaltose) vs. Placebo.
- Treatment Phase I: CGI-I [ Time Frame: Day 42 ]CGI-I (Clinical Global Impression- Improvement) at Day 42.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826681
|Contact: James Bambrick, BS||631-772-3518||JBambrick@americanregent.com|
|Contact: Mark Falone, MDfirstname.lastname@example.org|
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|Lemon Grove, California, United States, 91945|
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|Alliance for Multispeciality Research||Active, not recruiting|
|Fort Myers, Florida, United States, 33912|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224-2780|
|Contact: Emily Rost 410-550-1046 email@example.com|
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|South Dartmouth, Massachusetts, United States, 02169|
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|Las Vegas, Nevada, United States, 89128|
|Contact: Angela Gomez 702-425-1798 Angela.firstname.lastname@example.org|
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|United States, Texas|
|Clinical Trial Network||Active, not recruiting|
|Houston, Texas, United States, 77074|
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|Seattle, Washington, United States, 98104|