Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

A Randomized Placebo Controlled Study of Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02221570
• Other study ID #: baclofen cramps
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2014
• Last updated: October 2, 2014
• Start date: June 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: Tanta University
• Contact: Asem A Elfert, MD
• Phone: +20-122-437-8188
• Email: asem1967[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review BoardEgypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Muscle Cramp
• Muscle Cramps
• Spasm

Intervention

Drug:
• Baclofen
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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

Burke AM, White AB, Brill N. Baclofen for intractable hiccups. N Engl J Med. 1988 Nov 17;319(20):1354. — View 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. — View Citation

Froestl W. Chemistry and pharmacology of GABAB receptor ligands. Adv Pharmacol. 2010;58:19-62. doi: 10.1016/S1054-3589(10)58002-5. — View Citation

Hering-Hanit R, Gadoth N. The use of baclofen in cluster headache. Curr Pain Headache Rep. 2001 Feb;5(1):79-82. — View Citation

Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J. 1971 Oct 2;4(5778):15-7. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo.		3 months	Yes