Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Cramps, Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Dronabinol
Sponsored by
About this trial
This is an interventional treatment trial for Cramps focused on measuring ALS, cramps, THC, Dronabinol
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
Sites / Locations
- Kantonsspital St.Gallen
Outcomes
Primary Outcome Measures
severity of cramps
Secondary Outcome Measures
Full Information
NCT ID
NCT00812851
First Posted
November 21, 2008
Last Updated
February 17, 2009
Sponsor
Cantonal Hospital of St. Gallen
Collaborators
ALS Association
1. Study Identification
Unique Protocol Identification Number
NCT00812851
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cantonal Hospital of St. Gallen
Collaborators
ALS Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cramps, Amyotrophic Lateral Sclerosis
Keywords
ALS, cramps, THC, Dronabinol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dronabinol
Primary Outcome Measure Information:
Title
severity of cramps
Time Frame
2 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kantonsspital St.Gallen
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland
12. IPD Sharing Statement
Links:
URL
http://www.muskel-als-sg.ch/
Description
Related Info
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Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)
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