A Double-Blinded, Multi-Center, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) in the Treatment of Restless Legs Syndrome (RLS)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001521-16-HU

Enrollment

200

Registered

2015-04-22

Start date

2015-07-15

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Leg Syndrome (RLS) MedDRA version: 18.0 Level: PT Classification code 10058920 Term: Restless legs syndrome System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Injectafer® Pharmaceutical Form: Solution for injection INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female subjects =18 years of age or older, able and willing to give informed consent to the study 2. RLS symptoms affirming diagnosis. The IRLS Diagnostic Criteria for RLS must be met: a. An urge (distressing need) to move the legs usually associated with painful or uncomfortable sensations in the legs. The urge to move may be present without the uncomfortable sensations. The arms or other body parts may be involved in addition to the legs. b. The urge to move or unpleasant sensations are worse or exclusively present at rest or inactivity, such as lying down or sitting. c. The urge to move or unpleasant sensations are partially/temporarily relieved with walking or moving the legs. d. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. When symptoms are severe, the worsening at night may not be noticeable but must have been previously present. 3. Subjects should be on monotherapy for RLS. Treatment should be stable for at least 8 weeks prior to screening. (See approved RLS Therapies/Regimen in Appendix III in Study Protocol ) 4. A score = 15 on the IRLS Rating Scale at screening and on Day 0 prior to dosing. 5. Subjects on anti-depressants and sleep medications must be on a stable dose for at least 6 months. 6. Subject has regular sleep hours between 9 pm and 9 am. 7. Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control: have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. RLS 2° to other disease or injury. 2. Treatment of such disorders that require RLS indicators such as peripheral neuropathy and neurodegenerative disorders (i.e. Parkinson's Disease or Dementia). 3. Stage 4 – 5 CKD, subjects on dialysis or anticipated to start dialysis while participating in this study. 4. Any pain related (e.g., frequent muscle cramps, myalgia, fibromyalgia) or sleep related disorders (e.g. sleep apnea, unless on stable Continuous Positive Airway Pressure [CPAP]) which may confound the outcome measures. 5. Subjects with Multiple Sclerosis. 6. History of neuroleptic akathisia. 7. Parenteral iron use within 6 weeks prior to screening. 8. History of >10 blood transfusions in the past 2 years. 9. Anticipated need for blood transfusion during the study. 10. Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose). 11. Previously randomized to Injectafer® (FCM or VIT-45) in a clinical trial. 12. Current, active or acute or chronic infection other than viral upper respiratory tract infection. 13. Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for = 5 years). 14. Pregnant or lactating women. 15. Seizure disorder currently being treated with medication. 16. Baseline ferritin =300 ng/mL. 17. Baseline TSAT =45%. 18. History of hemochromatosis or hemosiderosis or other iron storage disorders. 19. AST or ALT greater than 2 times the upper limit of normal. 20. Hemoglobin greater than the upper limit of normal. 21. Known positive hepatitis B antigen (HBsAg) unless positive test can be attributed to receipt of hepatitis B vaccination in childhood or hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal). 22. Known positive HIV-1/HIV-2 antibodies (anti-HIV) 23. Received an investigational drug within 30 days before randomization. 24. Chronic alcohol or drug abuse within the past 6 months. 25. Any other pre-existing laboratory abnormality, medical condition or disease which per the investigator may put the subject at risk if they participate in the study. 26. Subject unable or unwilling to comply with the study requirements.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the efficacy and safety of an IV Injectafer® in subjects with Restless Leg Syndrome (RLS).;Secondary Objective: n/a;Timepoint(s) of evaluation of this end point: Day 42;Primary end point(s): The co-primary efficacy variables will be IRLS total score change from baseline to Day 42 and the proportion of patients rated as much or very much improved with the Clinical Global Impression (CGI) performed by Investigator (CGI-I) on Day 42. Baseline values used for evaluation will be defined as the latest value obtained prior to the first dose of study drug. For those subjects with only one value prior to dosing, the single value will be used as baseline.	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the efficacy and safety of an IV Injectafer® in subjects with Restless Leg Syndrome (RLS).;Secondary Objective: n/a;Timepoint(s) of evaluation of this end point: Day 42;Primary end point(s): The co-primary efficacy variables will be IRLS total score change from baseline to Day 42 and the proportion of patients rated as much or very much improved with the Clinical Global Impression (CGI) performed by Investigator (CGI-I) on Day 42. Baseline values used for evaluation will be defined as the latest value obtained prior to the first dose of study drug. For those subjects with only one value prior to dosing, the single value will be used as baseline.

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Secondary

Measure	Time frame
Secondary end point(s): The major secondary efficacy endpoints in ranked order of testing include: 1. Clinical Global Impression (CGI) performed by Subject (CGI-S) on Day 42. 2. Restless Legs Syndrome Quality of Life (RLS-QLI) change from baseline to Day 42. 3. Medical Outcome Study (MOS) Sleep Scale change from baseline to Day 42. 4. Fatigue Linear Analog Scale change from baseline to Day 42. Other efficacy endpoints: 1. Proportion of responders (any improvement) based on CGI-I at each time point. 2. IRLS total score change from baseline at each time point. 3. Proportion of responders based on CGI-S at each time point. 4. RLS-QLI scores change from baseline at each time point. 5. MOS Sleep scale total score change from baseline at each time point. 6. Fatigue Linear Analog Scale total score change from baseline at each time point. 7. Augmentation Scale change between baseline, Day 42, Day 168 and end of study (Day 365). 8. Proportion of subjects require intervention for RLS. 9. Number of days from Day 5 to next dose of study drug. The safety endpoints include: 1. Incidence of treatment emergent adverse events (TEAE) and incidence of serious adverse events (SAE) 2. Change in clinical laboratory tests 3. Change in vital signs 4. Change in Columbia-Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: As described in section E.5.2.	—

Measure

Time frame

Secondary end point(s): The major secondary efficacy endpoints in ranked order of testing include: 1. Clinical Global Impression (CGI) performed by Subject (CGI-S) on Day 42. 2. Restless Legs Syndrome Quality of Life (RLS-QLI) change from baseline to Day 42. 3. Medical Outcome Study (MOS) Sleep Scale change from baseline to Day 42. 4. Fatigue Linear Analog Scale change from baseline to Day 42. Other efficacy endpoints: 1. Proportion of responders (any improvement) based on CGI-I at each time point. 2. IRLS total score change from baseline at each time point. 3. Proportion of responders based on CGI-S at each time point. 4. RLS-QLI scores change from baseline at each time point. 5. MOS Sleep scale total score change from baseline at each time point. 6. Fatigue Linear Analog Scale total score change from baseline at each time point. 7. Augmentation Scale change between baseline, Day 42, Day 168 and end of study (Day 365). 8. Proportion of subjects require intervention for RLS. 9. Number of days from Day 5 to next dose of study drug. The safety endpoints include: 1. Incidence of treatment emergent adverse events (TEAE) and incidence of serious adverse events (SAE) 2. Change in clinical laboratory tests 3. Change in vital signs 4. Change in Columbia-Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: As described in section E.5.2.

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Countries

Czech Republic, Hungary, Poland, Spain, Ukraine

Contacts

Public ContactClinical Trial Information

Luitpold Pharmaceuticals, Inc.

abutcher@lpicrd.com0016106504200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026