Trial Outcomes & Findings for Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments (NCT NCT00895232)
NCT ID: NCT00895232
Last Updated: 2024-11-07
Results Overview
Validated rating scale of RLS symptoms (Range 1 \[mild\] - 40 \[severe\])
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline to Day 84
Results posted on
2024-11-07
Participant Flow
November 14, 2003 - August 8, 2005 Locations: Hospitals and Medical Clinics
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.
Participant milestones
| Measure |
Cohort I (Venofer 500mg x 1 Dose)
Single 500 mg infusion of Venofer over 4 hours.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
8
|
|
Overall Study
COMPLETED
|
4
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments
Baseline characteristics by cohort
| Measure |
Cohort I (Venofer 500mg x 1 Dose)
n=7 Participants
Single 500 mg infusion of Venofer over 4 hours.
|
Cohort II (Venofer 500mg X 2 Doses)
n=6 Participants
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.
|
Cohort III (Venofer 500mg x 2 Doses)
n=8 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 84Population: Only subjects who completed the IRLSSG Rating Scale at baseline AND on Day 84.
Validated rating scale of RLS symptoms (Range 1 \[mild\] - 40 \[severe\])
Outcome measures
| Measure |
Cohort I (Venofer 500mg x 1 Dose)
n=5 Participants
Single 500 mg infusion of Venofer over 4 hours.
|
Cohort II (Venofer 500mg X 2 Doses)
n=3 Participants
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.
|
Cohort III (Venofer 500mg x 2 Doses)
n=2 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale
|
-2.4 units on a scale
Standard Deviation 5.41
|
-14.3 units on a scale
Standard Deviation 5.03
|
-16.0 units on a scale
Standard Deviation 8.49
|
SECONDARY outcome
Timeframe: Baseline to Day 84Population: Only subjects who recorded PLM's/Hour at Baseline AND on Day 84.
Quantifies amount of leg movement
Outcome measures
| Measure |
Cohort I (Venofer 500mg x 1 Dose)
n=3 Participants
Single 500 mg infusion of Venofer over 4 hours.
|
Cohort II (Venofer 500mg X 2 Doses)
n=2 Participants
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.
|
Cohort III (Venofer 500mg x 2 Doses)
n=1 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)
|
-7.2 PLM's per hour
Standard Deviation 24.12
|
-75.0 PLM's per hour
Standard Deviation 49.71
|
-96.2 PLM's per hour
Standard Deviation 0
|
POST_HOC outcome
Timeframe: Baseline to Day 84Population: Only subjects who were evaluated at Baseline AND on Day 84
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.
Outcome measures
| Measure |
Cohort I (Venofer 500mg x 1 Dose)
n=7 Participants
Single 500 mg infusion of Venofer over 4 hours.
|
Cohort II (Venofer 500mg X 2 Doses)
n=3 Participants
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.
|
Cohort III (Venofer 500mg x 2 Doses)
n=3 Participants
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.
|
|---|---|---|---|
|
Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner.
|
28.6 percent of participants
|
66.7 percent of participants
|
66.7 percent of participants
|
Adverse Events
Cohort I (Venofer 500mg x 1 Dose)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort II (Venofer 500mg X 2 Doses)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort III (Venofer 500mg x 2 Doses)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort I (Venofer 500mg x 1 Dose)
n=7 participants at risk
Single 500 mg infusion of Venofer over 4 hours.
|
Cohort II (Venofer 500mg X 2 Doses)
n=6 participants at risk
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.
|
Cohort III (Venofer 500mg x 2 Doses)
n=8 participants at risk
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.
|
|---|---|---|---|
|
Investigations
Heart rate irregular
|
0.00%
0/7 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
Other adverse events
| Measure |
Cohort I (Venofer 500mg x 1 Dose)
n=7 participants at risk
Single 500 mg infusion of Venofer over 4 hours.
|
Cohort II (Venofer 500mg X 2 Doses)
n=6 participants at risk
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.
|
Cohort III (Venofer 500mg x 2 Doses)
n=8 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
33.3%
2/6 • Number of events 3 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/7 • 1 year and 9 months
|
16.7%
1/6 • Number of events 1 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Gastrointestinal disorders
Diarrhea NOS
|
0.00%
0/7 • 1 year and 9 months
|
16.7%
1/6 • Number of events 1 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • 1 year and 9 months
|
50.0%
3/6 • Number of events 3 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
|
General disorders
Fatigue
|
0.00%
0/7 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
|
Metabolism and nutrition disorders
Gout
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Vascular disorders
Hypotension NOS
|
0.00%
0/7 • 1 year and 9 months
|
50.0%
3/6 • Number of events 3 • 1 year and 9 months
|
25.0%
2/8 • Number of events 2 • 1 year and 9 months
|
|
General disorders
Injection site reaction NOS
|
0.00%
0/7 • 1 year and 9 months
|
16.7%
1/6 • Number of events 1 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
|
General disorders
Oedema NOS
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
33.3%
2/6 • Number of events 3 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
33.3%
2/6 • Number of events 2 • 1 year and 9 months
|
25.0%
2/8 • Number of events 3 • 1 year and 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.6%
2/7 • Number of events 2 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Vascular disorders
Phlebitis NOS
|
0.00%
0/7 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/7 • 1 year and 9 months
|
16.7%
1/6 • Number of events 1 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic NOS
|
0.00%
0/7 • 1 year and 9 months
|
16.7%
1/6 • Number of events 1 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
0.00%
0/7 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
|
Gastrointestinal disorders
Umbilical hernia NOS
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
0.00%
0/8 • 1 year and 9 months
|
|
Skin and subcutaneous tissue disorders
Urticaria NOS
|
14.3%
1/7 • Number of events 1 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
|
Gastrointestinal disorders
Vomiting NOS
|
0.00%
0/7 • 1 year and 9 months
|
0.00%
0/6 • 1 year and 9 months
|
12.5%
1/8 • Number of events 1 • 1 year and 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60