Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)

This study has been completed.

Sponsor:

Information provided by:

Luitpold Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01382901

First received: February 23, 2011

Last updated: July 8, 2011

Last verified: July 2011

History of Changes

Results First Received: February 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Restless Legs Syndrome (RLS)
Interventions:	Drug: Ferric Carboxymaltose (FCM) Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study Period: March 23, 2006 to July 16, 2007 Locations: Hospitals and Medical Clinics (15 total sites)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ferric Carboxymaltose (FCM) 2 x 500 mg	500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
Placebo	Intravenous (IV) solution of placebo on Day 0 and Day 5.

Participant Flow: Overall Study

	Ferric Carboxymaltose (FCM) 2 x 500 mg	Placebo
STARTED	24	21
COMPLETED	7	7
NOT COMPLETED	17	14

Baseline Characteristics

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Reporting Groups

	Description
Ferric Carboxymaltose (FCM) 2 x 500 mg	500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
Placebo	Intravenous (IV) solution of placebo on Day 0 and Day 5.
Total	Total of all reporting groups

Baseline Measures

	Ferric Carboxymaltose (FCM) 2 x 500 mg	Placebo	Total
Number of Participants [units: participants]	24	21	45
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	20	15	35
>=65 years	4	6	10
Age [units: years] Mean ± Standard Deviation	49.5 ± 11.42	54.1 ± 13.68	51.7 ± 12.59
Gender [units: participants]
Female	17	11	28
Male	7	10	17
Region of Enrollment [units: participants]
United States	24	21	45

Outcome Measures

1. Primary:

International Restless Legs Syndrome (IRLS) Total Score [ Time Frame: Change from Baseline to Day 28 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Marc Tokars
Organization: Luitpold Pharmaceuticals, Inc.
phone: 601-650-4200 ext 805
e-mail: mtokars@lpicrd.com

No publications provided

ClinicalTrials.gov Identifier:	NCT01382901 History of Changes
Other Study ID Numbers:	1VIT05009
Study First Received:	February 23, 2011
Results First Received:	February 23, 2011
Last Updated:	July 8, 2011
Health Authority:	United States: Food and Drug Administration

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