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

This study has been completed.
Sponsor:
Collaborator:
ALS Association
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00812851
First received: November 21, 2008
Last updated: February 17, 2009
Last verified: November 2008
  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

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: PD Dr. Markus Weber, Neuromuscular Diseases Unit, Kantonsspital St.Gallen
ClinicalTrials.gov Identifier: NCT00812851     History of Changes
Other Study ID Numbers: THC SG
Study First Received: November 21, 2008
Last Updated: February 17, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by Cantonal Hospital of St. Gallen:
ALS
cramps
THC
Dronabinol

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Muscle Cramp
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014