Trial Outcomes & Findings for Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis (NCT NCT03176966)
NCT ID: NCT03176966
Last Updated: 2022-10-31
Results Overview
Compare the incidence of muscle cramps in patients using vitamin E versus ropinirole. Patients complete a survey that assesses the frequency of muscle cramps from once weekly or less to multiple episodes per day. Frequency scale is 0 to 3 with 0 being once weekly or less and 3 being multiple episodes a day. Survey is completed at the end of 3 months on study intervention.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
3 months
Results posted on
2022-10-31
Participant Flow
31 subjects were consented and randomized. 1 subject became ill after randomization and was unable to participate so only 30 subjects took a first dose of assigned drug.
Participant milestones
| Measure |
Vitamin E Then Ropinirole
Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to Ropinirole. Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months.
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
|
Ropinirole Then Vitamin E
Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to vitamin E, 400 international units (IU). Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months.
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
|
|---|---|---|
|
Baseline to 3 Months (1st Intervention)
STARTED
|
14
|
16
|
|
Baseline to 3 Months (1st Intervention)
COMPLETED
|
10
|
9
|
|
Baseline to 3 Months (1st Intervention)
NOT COMPLETED
|
4
|
7
|
|
3 Month to 6 Months (2nd Intervention)
STARTED
|
10
|
9
|
|
3 Month to 6 Months (2nd Intervention)
COMPLETED
|
4
|
4
|
|
3 Month to 6 Months (2nd Intervention)
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Vitamin E Then Ropinirole
Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to Ropinirole. Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months.
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
|
Ropinirole Then Vitamin E
Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to vitamin E, 400 international units (IU). Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months.
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
|
|---|---|---|
|
Baseline to 3 Months (1st Intervention)
Death
|
2
|
1
|
|
Baseline to 3 Months (1st Intervention)
Withdrawal by Subject
|
1
|
4
|
|
Baseline to 3 Months (1st Intervention)
Lost to Follow-up
|
1
|
2
|
|
3 Month to 6 Months (2nd Intervention)
Death
|
0
|
1
|
|
3 Month to 6 Months (2nd Intervention)
Lost to Follow-up
|
3
|
4
|
|
3 Month to 6 Months (2nd Intervention)
Physician Decision
|
1
|
0
|
|
3 Month to 6 Months (2nd Intervention)
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis
Baseline characteristics by cohort
| Measure |
Vitamin E Then Ropinirole
n=14 Participants
Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to Ropinirole. Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months.
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
|
Ropinirole Then Vitamin E
n=16 Participants
Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to vitamin E, 400 international units (IU). Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months.
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 8.8 • n=93 Participants
|
61.8 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
58.0 years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
16 participants
n=4 Participants
|
30 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Of the 23 participants who received Vitamin E, data was analyzed for those who completed the survey at the end of each specific crossover period (n=14). Of the 26 participants who received Ropinirole, data was analyzed for those who completed the survey at the end of each specific crossover period (n=13).
Compare the incidence of muscle cramps in patients using vitamin E versus ropinirole. Patients complete a survey that assesses the frequency of muscle cramps from once weekly or less to multiple episodes per day. Frequency scale is 0 to 3 with 0 being once weekly or less and 3 being multiple episodes a day. Survey is completed at the end of 3 months on study intervention.
Outcome measures
| Measure |
Vitamin E Taken Nightly for 3 Months
n=14 Participants
Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. .
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
|
Ropinirole Taken Nightly for 3 Months
n=13 Participants
Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
|
|---|---|---|
|
Frequency of Muscle Cramps as Assessed by Patient Survey
|
1.14 score on a scale
Standard Deviation 0.99
|
1.23 score on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Of the 23 participants who received Vitamin E, data was analyzed for those who completed the survey at the end of each specific crossover period (n=14). Of the 26 participants who received Ropinirole, data was analyzed for those who completed the survey at the end of each specific crossover period (n=13).
Compare the severity of muscle cramps in patients using vitamin E versus ropinirole. Patients complete a survey that assesses muscle cramp pain on a scale from 0 to 10 with 0 being no pain and 10 being hurts worst. Survey is completed at the end of 3 months of study intervention.
Outcome measures
| Measure |
Vitamin E Taken Nightly for 3 Months
n=14 Participants
Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. .
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
|
Ropinirole Taken Nightly for 3 Months
n=13 Participants
Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
|
|---|---|---|
|
Muscle Cramp Severity as Assessed by Patient Survey
|
6.57 score on a scale
Standard Deviation 3.79
|
6.00 score on a scale
Standard Deviation 3.53
|
Adverse Events
Vitamin E
Serious events: 1 serious events
Other events: 1 other events
Deaths: 3 deaths
Ropinirole
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Vitamin E
n=23 participants at risk
Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. .
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
|
Ropinirole
n=26 participants at risk
Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
|
|---|---|---|
|
Hepatobiliary disorders
hepatic encephalopathy
|
4.3%
1/23 • Number of events 1 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
0.00%
0/26 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
Other adverse events
| Measure |
Vitamin E
n=23 participants at risk
Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. .
Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months.
|
Ropinirole
n=26 participants at risk
Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels.
Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months.
|
|---|---|---|
|
Cardiac disorders
chest pressure
|
0.00%
0/23 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Increased muscle cramps
|
0.00%
0/23 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/23 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
3.8%
1/26 • Number of events 1 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
|
Blood and lymphatic system disorders
bruising
|
4.3%
1/23 • Number of events 1 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
0.00%
0/26 • Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place