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

Phase 3

Recruiting

• Conditions: Liver Cirrhosis; Muscle Cramps
• Interventions: Drug: Placebo; Drug: orphenadrine

• Registration Number: NCT02423395
• Lead Sponsor: Sherief Abd-Elsalam

Brief 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. \[3,4\]

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 \[1\].

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.\[5\]

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-07
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	50 patients will be given placebo
Orphenadrine(Norflex)	orphenadrine	50 patients will be treated with orphenadrine 100 mg twice daily for 1 month

Primary Outcome Measures

Name	Time	Method
Frequency of muscle cramps	3 months	questionnaire

Secondary Outcome Measures

Name	Time	Method
Quality of life of these patients	3 months	questionnaire

Trial Locations

Locations (1)

Tanta university hospital; 🇪🇬 Tanta, Egypt