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Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over four to six hours on two separate dates, separated by two to seven days. The third cohort received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within 30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I | Experimental | 500 mg dose Venofer over 4 hours |
|
| Cohort II | Experimental | 500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7 |
|
| Cohort III | Experimental | 500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort I | Drug |
|
| |
| Cohort II |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale | Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe]) | Baseline to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's) | Quantifies amount of leg movement | Baseline to Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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A Baseline score > or = to 15 was required on the International RLS Study Group (IRLSSG) Rating Scale. At least 1 leg was required to have an average baseline Periodic Leg Movement (PLM) while asleep > or = to 15 movements per hour by actigraphy.
November 14, 2003 - August 8, 2005 Locations: Hospitals and Medical Clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort I (Venofer 500mg x 1 Dose) | Single 500 mg infusion of Venofer over 4 hours. |
| FG001 | Cohort II (Venofer 500mg X 2 Doses) | A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7. |
| FG002 | Cohort III (Venofer 500mg x 2 Doses) | A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort I (Venofer 500mg x 1 Dose) | Single 500 mg infusion of Venofer over 4 hours. |
| BG001 | Cohort II (Venofer 500mg X 2 Doses) | A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale | Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe]) | Only subjects who completed the IRLSSG Rating Scale at baseline AND on Day 84. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 84 |
|
1 year and 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort I (Venofer 500mg x 1 Dose) | Single 500 mg infusion of Venofer over 4 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart rate irregular | Investigations | MedDRA (6.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Falone, MD | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | 844 | mfalone@luitpold.com |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| Drug |
|
|
| Cohort III | Drug |
|
|
| BG002 | Cohort III (Venofer 500mg x 2 Doses) | A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Cohort III (Venofer 500mg x 2 Doses) | A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours. |
|
|
| Post-Hoc | Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner. | Response is defined as any effect based on a scale of 0 through 4 where 0 = no effect, 1 = mild effect, 2 = moderate effect, 3 = marked effect, and 4 = dramatic effect. | Only subjects who were evaluated at Baseline AND on Day 84 | Posted | Number | percent of participants | Baseline to Day 84 |
|
|
|
| Secondary | Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's) | Quantifies amount of leg movement | Only subjects who recorded PLM's/Hour at Baseline AND on Day 84. | Posted | Mean | Standard Deviation | PLM's per hour | Baseline to Day 84 |
|
|
|
| 0 |
| 7 |
| 5 |
| 7 |
| EG001 | Cohort II (Venofer 500mg X 2 Doses) | A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7. | 0 | 6 | 4 | 6 |
| EG002 | Cohort III (Venofer 500mg x 2 Doses) | A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours. | 1 | 8 | 5 | 8 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (6.0) | Systematic Assessment |
|
| Diarrhea NOS | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (6.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (6.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (6.0) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (6.0) | Systematic Assessment |
|
| Hypotension NOS | Vascular disorders | MedDRA (6.0) | Systematic Assessment |
|
| Injection site reaction NOS | General disorders | MedDRA (6.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (6.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Oedema NOS | General disorders | MedDRA (6.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (6.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (6.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (6.0) | Systematic Assessment |
|
| Phlebitis NOS | Vascular disorders | MedDRA (6.0) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (6.0) | Systematic Assessment |
|
| Rhinitis allergic NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Sweating increased | Skin and subcutaneous tissue disorders | MedDRA (6.0) | Systematic Assessment |
|
| Umbilical hernia NOS | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
| Urticaria NOS | Skin and subcutaneous tissue disorders | MedDRA (6.0) | Systematic Assessment |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA (6.0) | Systematic Assessment |
|
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| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |