Trial · NCT02298868
Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
NCT02298868, Phase 2, Completed, University of Virginia; results first posted 2015-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study. Trials, record NCT02298868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02298868
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
- NCT number
- NCT02298868
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Virginia
- Conditions
- Muscle Cramps, Cirrhosis
- Interventions
- Baclofen
- First posted
- 2014-11-24
- Last updated
- 2015-02-05
- Results first posted
- 2015-02-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache) | 4 weeks of active therapy | Proportion of patients with headache at any time during the 4 weeks of therapy |
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea) | 4 weeks of active therapy | Proportion of patients with nausea at any time during the 4 weeks of therapy |
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness) | 4 weeks of active therapy | Proportion of patients with dizziness at any time during the 4 weeks of therapy |
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy) | 4 weeks of active therapy | Proportion of patients with endephalopathy at any time during the 4 weeks of therapy |
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence) | 4 weeks of active therapy | Proportion of patients with somnolence at any time during the 4 weeks of therapy |
| Secondary | Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy | Baseline to 4 weeks of therapy | Patients undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps. This measures was repeated after 4 weeks of therapy and reported as the mean decrease in frequency of muscle cramps (4 weeks of therapy-Baseline). |
| Secondary | Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy | Baseline to end of 4 weeks of therapy | Patients undertook a muscle cramp questionnaire prior to treatment that measured severity in a 0-10 analog scale (0 is no pain and 10 is most severe pain). These measures were repeated after 4 weeks of therapy and the difference was assessed (4 weeks of therapy-Baseline). |
| Secondary | Change in Frequency of Muscle Cramps After Washout Period | End of treatment (week 4) to end of washout (week 7) | Subjects undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess frequency of muscle cramps. This was then compared to the end of therapy frequency to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result) |
| Secondary | Change in Severity of Muscle Cramps After Washout Period | End of treatment (week 4) to end of washout (week 7) | Subjects undertook a muscle cramp questionnaire prior to treatment that measured severity on a 0-10 analog scale (0 is no pain, 10 is most severe pain) and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess severity of muscle cramps. This was then compared to the end of therapy severity to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache) | 4 weeks of active therapy | participants | NUMBER | |
| SECONDARY | Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy | Baseline to 4 weeks of therapy | days/week | MEAN | |
| SECONDARY | Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy | Baseline to end of 4 weeks of therapy | units on a scale | MEAN | |
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea) | 4 weeks of active therapy | participants | NUMBER | |
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness) | 4 weeks of active therapy | participants | NUMBER | |
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy) | 4 weeks of active therapy | participants | NUMBER | |
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence) | 4 weeks of active therapy | participants | NUMBER | |
| SECONDARY | Change in Frequency of Muscle Cramps After Washout Period | End of treatment (week 4) to end of washout (week 7) | days/week | MEAN | |
| SECONDARY | Change in Severity of Muscle Cramps After Washout Period | End of treatment (week 4) to end of washout (week 7) | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache) | Treatment | 3 | participants | ||
| Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy | Treatment | -4.4 | Standard Deviation 3.3 | days/week | |
| Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy | Treatment | -6 | Standard Deviation 2.9 | units on a scale | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea) | Treatment | 4 | participants | ||
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness) | Treatment | 2 | participants | ||
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy) | Treatment | 0 | participants | ||
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence) | Treatment | 1 | participants | ||
| Change in Frequency of Muscle Cramps After Washout Period | Treatment | 3.0 | Standard Deviation 3.9 | days/week | |
| Change in Severity of Muscle Cramps After Washout Period | Treatment | 4.0 | Standard Deviation 4.0 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 10 | |
| Overall Study | COMPLETED | Treatment | 7 | |
| Overall Study | NOT COMPLETED | Treatment | 3 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Treatment | 3 | 10 | |
| other | Nausea | Gastrointestinal disorders | Treatment | 4 | 10 | |
| other | Dizziness | Nervous system disorders | Treatment | 2 | 10 | |
| other | Somnolence | Nervous system disorders | Treatment | 1 | 10 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | ||
| Total, other adverse events | Treatment | 6 | 10 |
| Total, serious adverse events | Treatment | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02298868
GET https://conductscience.org/api/trials/v1/NCT02298868/registered