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

Sponsors and Collaborators:	Cantonal Hospital of St. Gallen ALS Association
Information provided by:	Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT00812851

Purpose

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.

Condition	Intervention
Cramps Amyotrophic Lateral Sclerosis	Drug: Dronabinol

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Muscle Cramps

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:

severity of cramps [ Time Frame: 2 weeks after intervention ] [ Designated as safety issue: Yes ]

Enrollment:	24
Study Start Date:	April 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812851

Locations

Switzerland
Kantonsspital St.Gallen
St.Gallen, Switzerland, 9007

Sponsors and Collaborators

Cantonal Hospital of St. Gallen

ALS Association

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Neuromuscular Diseases Unit, Kantonsspital St.Gallen ( PD Dr. Markus Weber )
Study ID Numbers:	THC SG
Study First Received:	November 21, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812851
Health Authority:	Switzerland: Swissmedic

Keywords provided by Cantonal Hospital of St. Gallen:

ALS
cramps
THC
Dronabinol

Study placed in the following topic categories:

Spinal Cord Diseases
Central Nervous System Diseases
Sclerosis
Degenerative motor system disease
Muscle Cramp
Neurodegenerative Diseases
Motor neuron disease

Tetrahydrocannabinol
Amyotrophic lateral sclerosis
Neuromuscular Diseases
Amyotrophic Lateral Sclerosis
Lou Gehrig's disease
Motor Neuron Disease

Additional relevant MeSH terms:

Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Psychotropic Drugs
Hallucinogens
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009