NCT02298868

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

February 5, 2015

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

November 12, 2014

Results QC Date

January 6, 2015

Last Update Submit

February 4, 2015

Conditions

Muscle CrampsCirrhosis

Outcome Measures

Primary Outcomes (5)

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)

    Proportion of patients with headache at any time during the 4 weeks of therapy

    4 weeks of active therapy

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)

    Proportion of patients with nausea at any time during the 4 weeks of therapy

    4 weeks of active therapy

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)

    Proportion of patients with dizziness at any time during the 4 weeks of therapy

    4 weeks of active therapy

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)

    Proportion of patients with endephalopathy at any time during the 4 weeks of therapy

    4 weeks of active therapy

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)

    Proportion of patients with somnolence at any time during the 4 weeks of therapy

    4 weeks of active therapy

Secondary Outcomes (4)

  • 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

  • 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

  • Change in Frequency of Muscle Cramps After Washout Period

    End of treatment (week 4) to end of washout (week 7)

  • Change in Severity of Muscle Cramps After Washout Period

    End of treatment (week 4) to end of washout (week 7)

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: Baclofen

Interventions

BaclofenDRUG
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis
  • Presence of muscle cramps on a regular basis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscle CrampFibrosis

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Dr. Zachary Henry
Organization
University of Virginia
zhenry@virginia.edu
434-243-2718

Study Officials

  • Zachary Henry, M.D.

    University of Virginia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow Physician

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 24, 2014

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2014

Last Updated

February 5, 2015

Results First Posted

February 5, 2015

Record last verified: 2015-02