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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00812851
• Date of registration: 21/11/2008
• Prospective Registration: No
• Primary sponsor: Cantonal Hospital of St. Gallen
• Public title: Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)
• Scientific title: Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: April 2005
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00812851
• 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
• Phase: N/A

Countries of recruitment

Switzerland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cramps

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Dronabinol

Primary Outcome(s)

severity of cramps [Time Frame: 2 weeks after intervention]

Secondary ID(s)

THC SG

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ALS Association