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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

About this trial

This is an interventional treatment trial for Cramps focused on measuring ALS, cramps, THC, Dronabinol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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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