Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02298868

Enrollment

Registered

2014-11-24

Start date

2012-10-31

Completion date

2014-11-30

Last updated

2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Muscle Cramps

Brief 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.

Interventions

DRUGBaclofen

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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
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
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
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

Secondary

Measure	Time frame	Description
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).
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)
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)
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).

Participant flow

Participants by arm

Arm	Count
Treatment All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.	10
Total	10

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Death	1
Overall Study	Patient underwent transplant	1

Baseline characteristics

Characteristic	Treatment
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	10 Participants
Region of Enrollment United States	10 participants
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	6 / 10
serious Total, serious adverse events	0 / 10