Intravenous iron in the management of drug-resistant restless legs syndrome: a randomized controlled delayed-start trial. IRON-RLS

Conditions

Restless legs syndrome

Brief summary

The primary outcome measure is the change in the IRLSSG-Q score between visit V1 (baseline) and visit V3 (3 months after V1).

Detailed description

Change in the PLMS index between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group, Change in other polysomnographic parameters (total sleep time, wake after sleep onset, percentage of slow-wave sleep, and rapid eye movement sleep) between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group., Serum biological parameters [between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group] and cerebrospinal fluid (CSF) parameters [at V1 in the immediate-treatment group and at V3 in the delayed-treatment group]: ferritin and transferrin saturation., CSF biological parameters prior to intravenous FCM infusion in the immediate-treatment group (V1) and in the delayed-treatment group (V3): ferritin and transferrin saturation., Clinical response defined as a decrease of ≥3 points in the IRLSSG-Q score between V1 and V3, Change in ESS, ISI, BDI, ASRS, and EQ-5D scores between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group.

Related papers

No related papers found yet.

Interventions

DRUGFERRIC CARBOXYMALTOSE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the change in the IRLSSG-Q score between visit V1 (baseline) and visit V3 (3 months after V1).	—

Secondary

Measure	Time frame
Change in the PLMS index between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group, Change in other polysomnographic parameters (total sleep time, wake after sleep onset, percentage of slow-wave sleep, and rapid eye movement sleep) between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group., Serum biological parameters [between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group] and cerebrospinal fluid (CSF) parameters [at V1 in the immediate-treatment group and at V3 in the delayed-treatment group]: ferritin and transferrin saturation., CSF biological parameters prior to intravenous FCM infusion in the immediate-treatment group (V1) and in the delayed-treatment group (V3): ferritin and transferrin saturation., Clinical response defined as a decrease of ≥3 points in the IRLSSG-Q score between V1 and V3, Change in ESS, ISI, BDI, ASRS, and EQ-5D scores b	—

Measure

Time frame

Change in the PLMS index between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group, Change in other polysomnographic parameters (total sleep time, wake after sleep onset, percentage of slow-wave sleep, and rapid eye movement sleep) between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group., Serum biological parameters [between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group] and cerebrospinal fluid (CSF) parameters [at V1 in the immediate-treatment group and at V3 in the delayed-treatment group]: ferritin and transferrin saturation., CSF biological parameters prior to intravenous FCM infusion in the immediate-treatment group (V1) and in the delayed-treatment group (V3): ferritin and transferrin saturation., Clinical response defined as a decrease of ≥3 points in the IRLSSG-Q score between V1 and V3, Change in ESS, ISI, BDI, ASRS, and EQ-5D scores b

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Outcome results

None listed