Trial · NCT00109772

Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1

NCT00109772, Phase 2, Terminated, Celgene Corporation; results first posted 2013-08-28

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1. Trials, record NCT00109772. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00109772

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1
NCT number: NCT00109772
Status: Terminated
Phases: Phase 2
Enrollment: 184 participants, actual
Lead sponsor: Celgene Corporation
Conditions: Complex Regional Pain Syndrome, Type I
Interventions: lenalidomide, Placebo
First posted: 2005-05-04
Last updated: 2013-08-28
Results first posted: 2013-08-28

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	Day 0, Week 12	Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Responders are participants who completed 12 weeks of treatment and their week 12 PI-NRS score showed at least a 30% improvement from baseline. Participants who did not complete 12 weeks of treatment are considered non-responders.
Secondary	Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12	Day 0, week 12	Short Form McGill Pain Questionnaire (SF-MPQ) is comprised of 15 pain qualities that are rated by the participant on a 4 point scale with 0=none and 3=severe. The scale for the Total Score is 0-45. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.
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	Day 0, week 12	Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. Morning and evening scores are averaged. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.
Secondary	Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12	Day 0, week 12	Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The morning pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.
Secondary	Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12	Day 0, week 12	Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The evening pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.
Secondary	Change From Baseline in Daily Sleep Assessment Average Score at Week 12	Day 0, week 12	Participants rated how much CRPS pain interfered with their sleep each day in a diary. The Sleep Assessment uses an eleven point scale for four questions. Questions concern ability to fall asleep, ability to stay asleep, how refreshed the participant feels upon waking and how alert the participant is during the day. All use a scale of 0-10, where the higher number is the positive response (e.g. 0=Pain completely interferes with sleep and 10=Pain does not interfere). The mean of all four responses was calculated if at least 3 of the 4 questions had a value. Week 12 values are compared to baseline values. Positive change values indicate improvement.
Secondary	Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12	Day 0, week 12	Participants rated how the activity level on a given day compares with their activity level prior to the start of treatment. A seven-point scale is used with -3=much worse and +3=much better. Positive change values indicate improvement.
Secondary	Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12	Day 0, week 12	Participants rated twelve CRPS symptoms using a four-point rating scale in which 1=the most positive outcome and 4= the most negative outcome for a total scale of 12-48. Week 12 values are compared to baseline values. Negative change values indicate improvement.
Secondary	Change From Baseline in "Mechanically Evoked" (Allodynia) Numeric Rating Scale (NRS) Score at Week 12	Day 0, week 12	The investigator rated the degree of allodynia on both the CRPS-affected limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the baseline values for the CRPS affected-limb to the values at week 12. Negative change values indicate improvement.
Secondary	Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12	Week 12	The investigator rated the degree of allodynia on both the CRPS-affected limb and the normal (or less-affected) limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the values for the CRPS affected-limb to the normal limb at week 12.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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	Day 0, Week 12	Intent to treat	percentage of participants	NUMBER
SECONDARY	Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12	Day 0, week 12	Intent to treat. Last observation carried forward. Three participants had no post-treatment values.	units on a scale	MEAN
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	Day 0, week 12	Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12	Day 0, week 12	Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12	Day 0, week 12	Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.	units on a scale	MEAN
SECONDARY	Change From Baseline in Daily Sleep Assessment Average Score at Week 12	Day 0, week 12	Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.	units on a scale	MEAN
SECONDARY	Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12	Day 0, week 12	Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.	units on a scale	MEAN
SECONDARY	Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12	Day 0, week 12	Intent to treat population. Last observation carried forward. Thirty-three participants had either no baseline or post-treatment values.	units on a scale	MEAN
SECONDARY	Change From Baseline in Mechanically Evoked (Allodynia) Numeric Rating Scale (NRS) Score at Week 12	Day 0, week 12	Intent to treat population. Last observation carried forward. Sixteen participants had either no baseline or post-treatment values.	units on a scale	MEAN
SECONDARY	Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12	Week 12	Intent to treat population. Last observation carried forward. Fifteen participants were missing values.	units on a scale	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group52

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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	Lenalidomide	Responders	16.1		percentage of participants
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	Placebo to Lenalidomide	Responders	16.1		percentage of participants
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	Lenalidomide	Non-responders	83.9		percentage of participants
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	Placebo to Lenalidomide	Non-responders	83.9		percentage of participants
Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12	Lenalidomide		-5.2	Standard Deviation 9.15	units on a scale
Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12	Placebo to Lenalidomide		-3.0	Standard Deviation 9.37	units on a scale
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	Lenalidomide		-0.6	Standard Deviation 1.65	units on a scale
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	Placebo to Lenalidomide		-0.4	Standard Deviation 1.50	units on a scale
Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12	Lenalidomide		-0.6	Standard Deviation 1.67	units on a scale
Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12	Placebo to Lenalidomide		-0.4	Standard Deviation 1.53	units on a scale

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-blind Treatment	STARTED	Lenalidomide	90
Double-blind Treatment	STARTED	Placebo to Lenalidomide	94
Double-blind Treatment	Safety and ITT Population	Lenalidomide	87
Double-blind Treatment	Safety and ITT Population	Placebo to Lenalidomide	93
Double-blind Treatment	COMPLETED	Lenalidomide	68
Double-blind Treatment	COMPLETED	Placebo to Lenalidomide	79
Double-blind Treatment	NOT COMPLETED	Lenalidomide	22
Double-blind Treatment	NOT COMPLETED	Placebo to Lenalidomide	15
Open-label Extension	STARTED	Lenalidomide	64
Open-label Extension	STARTED	Placebo to Lenalidomide	78

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events102

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Rash NOS	Skin and subcutaneous tissue disorders	Lenalidomide	24	87
other	Rash NOS	Skin and subcutaneous tissue disorders	Placebo to Lenalidomide	9	93
other	Pruritus	Skin and subcutaneous tissue disorders	Lenalidomide	8	87
other	Pruritus	Skin and subcutaneous tissue disorders	Placebo to Lenalidomide	4	93
other	Contusion	Skin and subcutaneous tissue disorders	Lenalidomide	3	87
other	Contusion	Skin and subcutaneous tissue disorders	Placebo to Lenalidomide	6	93
other	Dry skin	Skin and subcutaneous tissue disorders	Lenalidomide	6	87
other	Dry skin	Skin and subcutaneous tissue disorders	Placebo to Lenalidomide	2	93
other	Nausea	Gastrointestinal disorders	Lenalidomide	14	87
other	Nausea	Gastrointestinal disorders	Placebo to Lenalidomide	15	93

1 to 10 of 102Source ClinicalTrials.gov

See all 102 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lenalidomide
Total, all-cause mortality	Placebo to Lenalidomide
Total, other adverse events	Lenalidomide	77	87
Total, other adverse events	Placebo to Lenalidomide	72	93
Total, serious adverse events	Lenalidomide	12	87
Total, serious adverse events	Placebo to Lenalidomide	16	93

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25283471	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Lenalidomide vs Placebo to Lenalidomide: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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