Central Neuropathic Pain in Multiple SclerosisPhase 3NCT00959218
Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis
A Phase 3 study testing Dronabinol in people with Central Neuropathic Pain in Multiple Sclerosis, run by Bionorica Research GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Central Neuropathic Pain in Multiple Sclerosis
- What is being tested?
- Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple sclerosis acc. to McDonald diagnostic criteria
- EDSS score between 3 and 8 (incl.)
- Patients who are in a stable phase of multiple sclerosis
- Patients with MS-related central neuropathic pain for at least 3 months
Who cannot join
- Severe concomitant diseases
- Certain concomitant therapies (in particular: pain influencing concomitant therapies)
- Dronabinol intake within the last 12 months prior to study entry or Marihuana use within one month prior to study entry
Trial locations and contacts
1 site in 1 country.
Germany1 site
Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie
Lüdenscheid, 58515
About this study
Official title: Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain
The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.
Read the detailed description
Multiple sclerosis (MS) is in all probability an autoimmune disease causing severe neurological disability due to inflammation and degeneration in the central nervous system (CNS). MS affects over 1 million people worldwide. Central neuropathic pain is associated with approximately 30% of all patients with MS. MS-accompanying pain has a major impact on the patients' quality of life as usual conventional analgesics are little effective. The aim of this clinical study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.
- Being tested
- Dronabinol, Placebo
- Keywords
- Dronabinol, (-)trans-delta9-tetrahydrocannabinol, central neuropathic pain, multiple sclerosis, analgesic, Central neuropathic pain related to multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called (-)trans-delta9-tetrahydrocannabinol
oral solution, daily dose up to 15 mg, treatment up to 2.5 years
PlaceboDrug
oral solution
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol | Experimental | Not described Receives: Drug: Dronabinol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary
Measured: max. 2.5 years
Secondary outcomes (4)
Likert Numerical Rating Scale pain relief
Measured: max. 2.5 years
Pain-related sleep interference
Measured: max. 2.5 years
SF-36 (QoL-questionnaire)
Measured: max. 2.5 years
Intake of rescue medication
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJun 2007
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Neuropathic Pain in Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica Research GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian Schimrigk, MD, Principal investigator, Klinikum Luedenscheid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959218
- Sponsor's protocol ID
- cnp-MS-0601 / MC-2006-01
- Status last verified
- Feb 2012
- First submitted
- 13 Aug 2009
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00959218
- Acronym / sponsor ID
- cnp-MS-0601 / MC-2006-01
- Keywords
- Dronabinol, (-)trans-delta9-tetrahydrocannabinol, central neuropathic pain, multiple sclerosis, analgesic, Central neuropathic pain related to multiple sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Bionorica Research GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.
Detailed description
Multiple sclerosis (MS) is in all probability an autoimmune disease causing severe neurological disability due to inflammation and degeneration in the central nervous system (CNS). MS affects over 1 million people worldwide. Central neuropathic pain is associated with approximately 30% of all patients with MS. MS-accompanying pain has a major impact on the patients' quality of life as usual conventional analgesics are little effective. The aim of this clinical study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dronabinol | Experimental | Drug: Dronabinol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of multiple sclerosis acc. to McDonald diagnostic criteria
- EDSS score between 3 and 8 (incl.)
- Patients who are in a stable phase of multiple sclerosis
- Patients with MS-related central neuropathic pain for at least 3 months
Key exclusion criteria (3 listed)
- Severe concomitant diseases
- Certain concomitant therapies (in particular: pain influencing concomitant therapies)
- Dronabinol intake within the last 12 months prior to study entry or Marihuana use within one month prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DronabinolAlso: (-)trans-delta9-tetrahydrocannabinoloral solution, daily dose up to 15 mg, treatment up to 2.5 years | Drug | Dronabinol |
| Placebooral solution | Drug | Placebo |
Primary outcome
Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary
Time frame: max. 2.5 years
4 secondary outcomes
Likert Numerical Rating Scale pain relief
Time frame: max. 2.5 years
Pain-related sleep interference
Time frame: max. 2.5 years
SF-36 (QoL-questionnaire)
Time frame: max. 2.5 years
Intake of rescue medication
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Schimrigk, MD principal investigator
Klinikum Luedenscheid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dronabinol in people with Central Neuropathic Pain in Multiple Sclerosis, run by Bionorica Research GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary (time frame: max. 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2012.