Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)

Many patients with ALS experience cramps during the course of the disease. Frequently, cramps occur as the first symptom of the disease, months before the patients notice weakness and wasting. Cramp severity varies from mild, without affecting daily activities and sleep, to disabling, where almost any voluntary muscle activity induces long standing, severely painful cramping. ALS patients who smoke herbal cannabis (marijuana) or drink hemp tea report lessening of cramps and fasciculations. Although, various medications, such as magnesium, quinine sulfate, lioresal, dantrolene, clonazepam, diphenylhydantoin and gabapentin are used for the treatment of cramps in ALS so far, no medication has been of proven benefit. However, a recent pilot study with THC in ALS showed symptomatic effects in "spasms", fasciculations, insomnia and appetite. The aim of the proposed study is to determine the tolerability, safety and efficacy of THC in the treatment of cramps in ALS. The hypothesis is that THC will lessen cramps in ALS.

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Key information

Conditions

Cramps Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Muscle Cramp Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must be at least 18 years of age and have full legal capacity
Patients must voluntarily give written informed consent
Patients diagnosed with possible, probable laboratory supported, probable or definite ALS according to the revised El Escorial criteria (Brooks 2000)
Patients must score severity of cramps on the VAS 5 or more
Patients must be able to communicate and report adverse events by phone
Patients must have laboratory parameters within the following limits: Creatinine, Bilirubin,Transaminases less than 3x upper limit of normal
Patients may take any medication for the treatment of ALS (ALS -specific and -symptomatic) but may not change this medication during the study period
Patients must not have cannabis or cannabinoids for at least one month prior to the study and agree not to use it at all during the study. They have to have a negative urinary test for cannabinoids at baseline
Pre-menopausal females must provide negative pregnancy test within fourteen days before beginning of study participation and have to apply adequate (barrier) birth-control methods
Patients must agree not to drive a vehicle or use dangerous machines during the entire study period

Exclusion criteria

Patients who are not willing or able to sign the consent form. Doubt of investigator concerning compliance of the patient
Patients who have a history of failure to respond to, or had significant adverse effects from or hypersensitivity to THC or any cannabinoid
Patients who have significant concomitant illness(-es), or acute, uncontrolled infections, which might make evaluation of treatment and side effects difficult
Patients with a history of significant psychiatric disorder, explicitly of schizophrenia
Patients who are current drug abusers, including alcohol abusers
Patients with severe coronary artery disease or hemodynamically relevant ECG-documented arrhythmia
Pregnancy or breast feeding

Treatment and study plan

Dronabinol

Drug

Primary outcomes

severity of cramps

Time frame: 2 weeks after intervention

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Collaborators

ALS Association

Registry information

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Dec 22, 2008
Registry last updated: Feb 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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