Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis

  • STATUS
    Recruiting
  • End date
    Dec 23, 2028
  • participants needed
    100
  • sponsor
    Sherief Abd-Elsalam
Updated on 23 January 2021
calcium
electrolytes
liver disease
cirrhosis
muscle spasms

Summary

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 (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]

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 [1].

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 [2].

Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4] Orphenadrine is structurally related to diphenhydramine and carries relatively stronger anticholinergic and weaker sedative properties, It is mostly excreted through the kidneys.[5]

Details
Condition Cirrhosis, Hepatic Fibrosis, LIVER DISEASE, LIVER DISEASE, Liver Disorders, Muscle Spasm, Muscle Cramp, Hepatic Fibrosis, Liver Disorders, muscle spasms, spasms, spasm, cramping, cramp, muscle cramps, cramps, hepatic cirrhosis, liver cirrhosis
Treatment Placebo, orphenadrine, orphenadrine
Clinical Study IdentifierNCT02423395
SponsorSherief Abd-Elsalam
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Cirrhosis
Muscle cramps( 3 cramps per week )

Exclusion Criteria

Allergy to orphenadrine
Renal impairment
Pregnant and lactating women
Peripheral vascular disease
Peripheral neuropathy
Medications as calcium channel blockers, conjugated estrogens and naproxen. Glaucoma Prostatic enlargement
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