Muscle CrampsPhase 2NCT02298868

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

A Phase 2 study testing Baclofen in people with Muscle Cramps and Cirrhosis, run by University of Virginia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Muscle Cramps, Cirrhosis
What is being tested?: Baclofen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: Oct 2012to Nov 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Cirrhosis
Presence of muscle cramps on a regular basis

Who cannot join

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

Show all 12Show fewer

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

About this study

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.

Conditions: Muscle Cramps, Cirrhosis
Being tested: Baclofen
Medical subject headings: Muscle Cramp, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BaclofenDrug

Study groups in NCT02298868
Study group	Role	What they receive
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. Receives: Drug: Baclofen

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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).
Measured: Baseline to 4 weeks of therapy
Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 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).
Measured: Baseline to end of 4 weeks of therapy
Change in Frequency of Muscle Cramps After Washout Period
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)
Measured: End of treatment (week 4) to end of washout (week 7)
Change in Severity of Muscle Cramps After Washout Period
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)
Measured: End of treatment (week 4) to end of washout (week 7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Nov 2014

First posted24 Nov 2014 (estimated)
Study startOct 2012
Primary completionNov 2013
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Muscle CrampsStudies of the same condition, open and under way.
More trials run by University of VirginiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02298868
Sponsor's protocol ID: 16306
Status last verified: Feb 2015
First submitted: 12 Nov 2014
Last updated: 5 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Muscle Cramps trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
ClinicalTrials.gov ID: NCT02298868
Acronym / sponsor ID: 16306
Conditions: Muscle Cramps, Cirrhosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Study start: Oct 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 2014 (actual)
First posted: 24 Nov 2014 (estimated)
Results: Posted 5 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Drug: BaclofenAll 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Cirrhosis
Presence of muscle cramps on a regular basis

Key exclusion criteria (12 listed)

Allergy or hypersensitivity to Baclofen
Active or untreated Portosystemic encephalopathy
Active alcohol or substance abuse
Age less than 18
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Baclofen	Drug	Treatment

Primary outcome

Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 4 weeks of active therapy
Proportion of patients with endephalopathy at any time during the 4 weeks of therapy
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)
Time frame: 4 weeks of active therapy
Proportion of patients with somnolence at any time during the 4 weeks of therapy

4 secondary outcomes

Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy
Time frame: Baseline to 4 weeks of therapy
Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy
Time frame: Baseline to end of 4 weeks of therapy
Change in Frequency of Muscle Cramps After Washout Period
Time frame: End of treatment (week 4) to end of washout (week 7)
Change in Severity of Muscle Cramps After Washout Period
Time frame: End of treatment (week 4) to end of washout (week 7)

Results and safety

Results posted to the registry on 5 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	10	7

Primary outcome: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)

Time frame: 4 weeks of active therapy. Number. Unit: participants

Measure	Treatment n = 10
Value	3

Primary outcome: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)

Time frame: 4 weeks of active therapy. Number. Unit: participants

Measure	Treatment n = 10
Value	4

Primary outcome: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)

Time frame: 4 weeks of active therapy. Number. Unit: participants

Measure	Treatment n = 10
Value	2

Primary outcome: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)

Time frame: 4 weeks of active therapy. Number. Unit: participants

Measure	Treatment n = 10
Value	0

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 10 (0%)	6 of 10 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zachary Henry, M.D. principal investigator

University of Virginia

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Baclofen in people with Muscle Cramps and Cirrhosis, run by University of Virginia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache) (time frame: 4 weeks of active therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02298868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.