Phase 2
Completed N=10
Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
Muscle Cramps · Cirrhosis
Source: ClinicalTrials.gov NCT02298868 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache) — 3 participants
Summary
The purpose of this study is to determine the safety and efficacy of the medication Baclofen for treatment of muscle cramps in patients with cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache) |
3 | — |
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea) |
4 | — |
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness) |
2 | — |
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy) |
— | — |
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence) |
1 | — |
| SECONDARY Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy |
-4.4 | — |
| SECONDARY Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy |
-6 | — |
| SECONDARY Change in Frequency of Muscle Cramps After Washout Period |
3.0 | — |
| SECONDARY Change in Severity of Muscle Cramps After Washout Period |
4.0 | — |
Eligibility Criteria
Inclusion Criteria
- Cirrhosis
- Presence of muscle cramps on a regular basis
Exclusion Criteria
- Allergy or hypersensitivity to Baclofen
- Active or untreated Portosystemic encephalopathy
- Active alcohol or substance abuse
- Age less than 18
- Pregnancy
- Concomitant use of narcotic pain medication, other muscle relaxer, or other anti-spastic agent
- Concomitant use of Tricyclic Antidepressant due to drug interaction
- History of chronic kidney disease defined by GFR < 30 (using MDRD equation)
- Subject is institutionalized or a prisoner
- Inability or unwillingness to give informed consent
- Expected lifespan less than 3 months
- Severe or poorly controlled coexisting medical conditions or other significant issues as determined by the principal investigator to hinder the ability to adhere to study protocols
Data sourced from ClinicalTrials.gov (NCT02298868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.