Mexiletine for the Treatment of Muscle Cramps in ALS

NCT01811355 | Completed Phase 4 Results

• 1 other identifier: 378164
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to determine if mexiletine is effective for the treatment of muscle cramps in Amyotrophic Lateral Sclerosis (ALS).

Conditions

Muscle Cramps in Amyotrophic Lateral Sclerosis

Keywords

Muscle cramps; Cramp; ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig's disease; Motor Neuron Disease; MND

Outcome Measures

Primary Outcomes (2)

• Daily Muscle Cramps

  The average of the daily recording of number of muscle cramps that occurred in the last 24 hours- over a 6 week period.

  6 weeks

• Cramp Severity

  Daily cramp severity was rated on the 100-unit visual analog scale. Scores ranged from 0 to 100, with 100 being the greatest amount of cramp severity

  6 weeks

Study Arms (2)

Mexiletine

ACTIVE COMPARATOR

Mexiletine, capsule, 150mg, PO BID, 14 days

Drug: Mexiletine

Placebo

PLACEBO COMPARATOR

Placebo, capsule, PO BID, 14 days

Drug: Placebo

Interventions

Mexiletine DRUG

Sodium channel blocker

Also known as: Mexetil

Mexiletine

Placebo DRUG

Placebo

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALS diagnosed according to El Escorial criteria (Awaji version) as: Possible, Probable, or Definite.
• Experiencing cramps as a moderate or severe symptom as defined by willingness to take a medication for the symptom
• ≥2 cramps per week during run in week
• Life expectancy \> 6 months, estimated by clinician
• Able to take drug capsule by mouth
• No significant EKG abnormality on screening
• aspartate aminotransferase / alanine aminotransferase \<2x upper limit of normal measured at screening
• Having successfully filled out the cramp diary and cramp and fasciculation scales on six out of the last seven days of run in period

You may not qualify if:

• Inability to communicate by telephone or email
• Allergy/ known sensitivity to mexiletine
• Prior use of mexiletine
• AV block unless subject has pacemaker
• Cardiac arrhythmia
• Prior myocardial infarction
• Other significant EKG abnormality
• Liver disease
• History of leucopenia (WBC \<3,500/mm3)
• Epilepsy
• Other serious and unstable medical condition
• Pregnant woman
• Breastfeeding woman
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Use of quinidine (alone or as a component of Nuedexta®) during the study

Sponsors & Collaborators

• Bjorn Oskarsson, MD: lead
• University of California, Davis: collaborator
• ALS Association: collaborator

Study Sites (6)

UCD Telehealth Network - Lake Almanor Clinic

Chester, California, 96020, United States

Location

UCSD Department of Neurosciences ALS Clinical Trials (ACT) Program

La Jolla, California, 92093, United States

Location

UCLA Neuromuscular Research Program

Los Angeles, California, 90095, United States

Location

UCD Telehealth Network

Multiple Locations, California, Various, United States

Location

UC Irvine Health ALS & Neuromuscular Center

Orange, California, 92868, United States

Location

UC, Davis Medical Center ALS Clinic

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Muscle Cramp; Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Interventions

Mexiletine; Sugars

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Carbohydrates

Results Point of Contact

• Title: Dr. Bjorn Oskarsson
• Organization: Mayo Clinic, Jacksonville

oskarsson.bjorn@mayo.edu

9049536896

Study Officials

• Bjorn Oskarsson, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Clinical Neurology

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 14, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 28, 2017
• Results First Posted: June 27, 2017

Record last verified: 2017-07

Locations

US (6)