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

• ClinicalTrials.gov Identifier: NCT00812851
• Recruitment Status: Completed
• First Posted: December 22, 2008
• Last Update Posted: February 19, 2009
• Sponsor: Cantonal Hospital of St. Gallen
• Collaborator: ALS Association
• Information provided by: Cantonal Hospital of St. Gallen

Tracking Information

• First Submitted Date: November 21, 2008
• First Posted Date: December 22, 2008
• Last Update Posted Date: February 19, 2009
• Study Start Date: April 2005
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 19, 2008): severity of cramps [ Time Frame: 2 weeks after intervention ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)
• Official Title: Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Cramps
• Amyotrophic Lateral Sclerosis

• Intervention: Drug: Dronabinol
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2008): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2008
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT00812851
• Other Study ID Numbers: THC SG
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: PD Dr. Markus Weber, Neuromuscular Diseases Unit, Kantonsspital St.Gallen
• Study Sponsor: Cantonal Hospital of St. Gallen
• Collaborators: ALS Association
• Investigators: Not Provided
• PRS Account: Cantonal Hospital of St. Gallen
• Verification Date: November 2008