Clinical trial NCT02221570: Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
Official title: A Randomized Placebo Controlled Study of Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Cramps
Liver Cirrhosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are associated with significantly diminished quality of life.

The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

Detailed description: Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes.

Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.

Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.

The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

Eligibility criteria: Inclusion Criteria:

* Cirrhosis
* Muscle cramps( ≥3 cramps per week )

Exclusion Criteria:

* Allergy to baclofen
* Renal impairment
* Pregnant and lactating women
* Peripheral vascular disease
* Peripheral neuropathy
* Medications as calcium channel blockers, conjugated estrogens and naproxen.

Primary outcomes:
measure: Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Gharbia
Study officials:
affiliation: Tanta Faculty of Medicine, Professor
name: Asem A Elfert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta Faculty of Medicine, Lecturer
name: Lobna A AboAli
role: STUDY_DIRECTOR
affiliation: Tanta Faculty of Medicine, Lecturer
name: Samah M Soliman
role: STUDY_DIRECTOR
affiliation: Tanta University Hospitals, House Officer
name: Ibrahim Shebl
role: STUDY_DIRECTOR
References:
citation: Chatrath H, Liangpunsakul S, Ghabril M, Otte J, Chalasani N, Vuppalanchi R. Prevalence and morbidity associated with muscle cramps in patients with cirrhosis. Am J Med. 2012 Oct;125(10):1019-25. doi: 10.1016/j.amjmed.2012.03.012. Epub 2012 Jul 24.
citation: Mehta SS, Fallon MB. Muscle cramps in liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1385-91; quiz e80. doi: 10.1016/j.cgh.2013.03.017. Epub 2013 Mar 28.
citation: Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J. 1971 Oct 2;4(5778):15-7. doi: 10.1136/bmj.4.5778.15.
citation: Hering-Hanit R, Gadoth N. The use of baclofen in cluster headache. Curr Pain Headache Rep. 2001 Feb;5(1):79-82. doi: 10.1007/s11916-001-0014-1.
citation: Orr WC, Goodrich S, Wright S, Shepherd K, Mellow M. The effect of baclofen on nocturnal gastroesophageal reflux and measures of sleep quality: a randomized, cross-over trial. Neurogastroenterol Motil. 2012 Jun;24(6):553-9, e253. doi: 10.1111/j.1365-2982.2012.01900.x. Epub 2012 Mar 8.
citation: Burke AM, White AB, Brill N. Baclofen for intractable hiccups. N Engl J Med. 1988 Nov 17;319(20):1354. doi: 10.1056/NEJM198811173192016. No abstract available.
citation: Froestl W. Chemistry and pharmacology of GABAB receptor ligands. Adv Pharmacol. 2010;58:19-62. doi: 10.1016/S1054-3589(10)58002-5.