Complex Regional Pain Syndrome, Type 1Phase 3NCT00166452
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
A Phase 3 study testing Lenalidamide in people with Complex Regional Pain Syndrome, Type 1, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndrome, Type 1
- What is being tested?
- Lenalidamide
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Feb 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = to 18 years
- Signed consent form
- A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
- CRPS pain intensity score at least 4 on an 11-point PI-NRS
- Measurable sural, median sensory, median motor and peroneal motor nerve conductions
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting the study drug. They must agree to use adequate contraceptive methods not including steroid-based contraceptives. They must also agree to have pregnancy tests every 4 weeks while on the study drug.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1
The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).
- Conditions
- Complex Regional Pain Syndrome, Type 1
- Being tested
- Lenalidamide
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionApr 2007
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome, Type 1Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Elgene Chemical
- Investigators
- Keith A Bengtson, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166452
- Sponsor's protocol ID
- 422-05
- Status last verified
- Mar 2011
- First submitted
- 12 Sep 2005
- Last updated
- 23 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1
- ClinicalTrials.gov ID
- NCT00166452
- Acronym / sponsor ID
- 422-05
- Conditions
- Complex Regional Pain Syndrome, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Elgene Chemical
- Study start
- Jul 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Sep 2005 (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 if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > or = to 18 years
- Signed consent form
- A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
- CRPS pain intensity score at least 4 on an 11-point PI-NRS
- Measurable sural, median sensory, median motor and peroneal motor nerve conductions
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lenalidamide | Drug | – |
Primary outcome
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
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 23 Mar 2011.
Related trials for Complex Regional Pain Syndrome, Type 1
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
RecruitingObservational study
CRPS-RISE Outcomes Registry
Complex Regional Pain Syndrome I (CRPS I)
Recruiting
ESWT for CRPS-I After Distal Radius Fracture
Complex Regional Pain Syndrome Type I (CRPS-I), Distal Radius Fracture
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.
Keith A Bengtson, M.D. principal investigator
Mayo Clinic
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 Lenalidamide in people with Complex Regional Pain Syndrome, Type 1, run by Mayo Clinic at 1 site in United States.
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 6 inclusion and 0 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 23 Mar 2011. 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 United States. 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. 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?
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline. 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 23 Mar 2011.