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Trial record 18 of 130 for:    Complex Regional Pain Syndrome

Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1 (CRPS-002)

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ClinicalTrials.gov Identifier: NCT00109772
Recruitment Status : Terminated (Interim analysis showed the primary outcome was not reached)
First Posted : May 4, 2005
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Complex Regional Pain Syndrome, Type I
Interventions: Drug: lenalidomide
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 184 participants were randomized to the study and 180 participants received at least 1 dose of study drug.

Reporting Groups
  Description
Lenalidomide 10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo to Lenalidomide Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.

Participant Flow for 2 periods

Period 1:   Double-blind Treatment
    Lenalidomide   Placebo to Lenalidomide
STARTED   90   94 
Safety and ITT Population   87 [1]   93 [1] 
COMPLETED   68   79 
NOT COMPLETED   22   15 
Adverse Event                14                5 
Lack of Efficacy                1                0 
Withdrawal by Subject                2                1 
Lost to Follow-up                2                3 
Protocol Violation                0                1 
not specified                0                4 
Withdrew prior to treatment                3                1 
[1] Safety: at least one dose of study drug ITT: treated and at least one post dose diary measurement

Period 2:   Open-label Extension
    Lenalidomide   Placebo to Lenalidomide
STARTED   64 [1]   78 [2] 
COMPLETED   19 [3]   29 [3] 
NOT COMPLETED   45   49 
Adverse Event                10                19 
Lack of Efficacy                19                11 
Withdrawal by Subject                9                6 
Lost to Follow-up                1                0 
Death                0                1 
Protocol Violation                2                2 
not specified                4                10 
[1] Four double-blind participants did not continue into the open-label extension
[2] One double-blind participant did not continue into the open-label extension
[3] Participants who were active in extension period when the sponsor terminated the study.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population

Reporting Groups
  Description
Lenalidomide 10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Placebo to Lenalidomide Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
Total Total of all reporting groups

Baseline Measures
   Lenalidomide   Placebo to Lenalidomide   Total 
Overall Participants Analyzed 
[Units: Participants]
 87   93   180 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.9  (11.37)   45.1  (11.06)   44.5  (11.20) 
Gender 
[Units: Participants]
     
Female   65   79   144 
Male   22   14   36 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   81   86   167 
Black   3   4   7 
Hispanic   1   3   4 
Asian/Pacific Islander   2   0   2 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment   [ Time Frame: Day 0, Week 12 ]

2.  Secondary:   Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12   [ Time Frame: Day 0, week 12 ]

3.  Secondary:   Change From Baseline in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score Using Averaged Morning and Evening Readings at Week 12   [ Time Frame: Day 0, week 12 ]

4.  Secondary:   Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12   [ Time Frame: Day 0, week 12 ]

5.  Secondary:   Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12   [ Time Frame: Day 0, week 12 ]

6.  Secondary:   Change From Baseline in Daily Sleep Assessment Average Score at Week 12   [ Time Frame: Day 0, week 12 ]

7.  Secondary:   Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12   [ Time Frame: Day 0, week 12 ]

8.  Secondary:   Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12   [ Time Frame: Day 0, week 12 ]

9.  Secondary:   Change From Baseline in “Mechanically Evoked” (Allodynia) Numeric Rating Scale (NRS) Score at Week 12   [ Time Frame: Day 0, week 12 ]

10.  Secondary:   Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12   [ Time Frame: Week 12 ]

11.  Secondary:   Change From Baseline in the Brief Pain Inventory (BPI) Total Score at Week 12   [ Time Frame: Day 0, week 12 ]

12.  Secondary:   Change From Baseline in the Profile of Mood States (POMS) at Week 12   [ Time Frame: Day 0, week 12 ]

13.  Secondary:   Patient Global Impression of Change (PGIC) at Week 12   [ Time Frame: Week 12 ]

14.  Secondary:   Participants Who Had a Change to CRPS Pain Medication During the Treatment Period   [ Time Frame: Day 1 to week 12 ]

15.  Secondary:   Change From Baseline in the Maximal Composite Motor Nerve Conduction Velocity at Week 12   [ Time Frame: Day 0, week 12 ]

16.  Secondary:   Change From Baseline in the Maximal Composite Sensory Nerve Conduction Velocity at Week 12   [ Time Frame: Day 0, week 12 ]

17.  Secondary:   Participants With Treatment-Emergent Adverse Events in the Double-Blind Period or the Extension Period   [ Time Frame: Day 1 up to week 158 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT00109772     History of Changes
Other Study ID Numbers: CC-5013-CRPS-002
First Submitted: May 3, 2005
First Posted: May 4, 2005
Results First Submitted: May 7, 2013
Results First Posted: August 28, 2013
Last Update Posted: August 28, 2013