Study to Evaluate the Efficacy and Safety of Lenalidomide... | NCT00109772

NCT00109772

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lenalidomide	Experimental	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.	Drug: lenalidomide
Placebo	Placebo Comparator	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.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
lenalidomide	Drug	Two 5 mg capsules taken one time per day	lenalidomide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	Day 0, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years at the time of signing the informed consent form
Understand and voluntarily sign an informed consent form
A diagnosis of CRPS Type 1, as defined by modified International Association for the Study of Pain criteria for at least a one-year duration. Unilateral involvement of a distal limb (hand or foot) with or without proximal spread must be present. In the presence of upper and lower limb involvement, the most severely affected limb will be designated the CRPS-affected limb.
Screening: CRPS pain intensity score in the CRPS-affected limb must be at least 4 on an 11-point (0-10) Pain Intensity Numerical Rating Scale (PI-NRS).
Randomization: Average PI-NRS score for randomization purposes will be based on AM and PM assessments made during the 7 days prior to randomization. At least eight PI-NRS scores during this 7-day period are required and the Average PI-NRS score in the CRPS-affected limb during this period must be at least 4 on an 11-point (0-10) PI-NRS.
Measurable (by electrophysiology methods) sural, median sensory, median motor and peroneal motor nerves at the screening nerve conduction study.
Opioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants, antidepressant drugs and other non-drug therapies may be continued provided that the subject is on stable doses/regimens for at least four weeks prior to the start of the Treatment Phase (Visit 2).
Able to adhere to the study visit schedule and other protocol requirements.
Women of childbearing potential (WCBP) must agree to practice complete abstinence from heterosexual intercourse or to use two methods of contraception beginning 4 weeks prior to the start of study drug (Day 1) while on study drug (including dose interruptions) and 4 weeks after the last dose of study drug. The two methods of contraception must include one highly effective method (i.e. intrauterine device [IUD], hormonal [birth control pills, injections, or implants only if used in conjunction with a low-dose (81 mg/day) aspirin regimen], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). If a hormonal method (birth control pills, injections, or implants) or IUD is not medically possible for the subject, two of the barrier methods will be acceptable.
Women of childbearing potential (WCBP) must have two negative pregnancy tests (sensitivity of at least 50 mlU/mL) prior to starting study drug treatment. The first test should be performed within 10-14 days and the second within 24 hours of starting study drug. Once treatment has started, it is recommended that subjects have weekly pregnancy test during the first 4 weeks of treatment. Thereafter, subjects are required to have pregnancy testing every 4 weeks in females with regular menstrual cycles and every 2 weeks in females with irregular cycles.
Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study drug and for 4 weeks after the last dose of study drug.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment:

History of deep vein thrombosis (DVT) or stroke in the past 5 years.
Documented peripheral neuropathies to include diabetic neuropathy and other metabolic or toxic neuropathies.
Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease.
Any other serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
White blood cell count (WBC) < 3.5*10^9/L at screening.
Bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) or alkaline phosphatase levels more than two times the upper limit of the normal range at screening.
Abnormal thyroid function test values at screening.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of concomitant medication(s), which could increase the risk for developing DVT, except for steroid-based contraceptives (oral injectable, implantable) and hormone replacement therapies only if used in conjunction with a low-dose (81 mg/day) aspirin regimen.
Concurrent use of thalidomide.
Prior development of an allergic reaction/hypersensitivity while taking thalidomide.
Prior development of a moderate or severe rash or any desquamation while taking thalidomide.
Prior treatment with lenalidomide.

Contacts/Locations Module

Name	Affiliation	Role
Donald C Manning, MD, PhD	Celgene Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pivotal Research Centers		Peoria	Arizona	85381	United States
UCSD Center for Pain and Palliative Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25283471	Derived	Manning DC, Alexander G, Arezzo JC, Cooper A, Harden RN, Oaklander AL, Raja SN, Rauck R, Schwartzman R. Lenalidomide for complex regional pain syndrome type 1: lack of efficacy in a phase II randomized study. J Pain. 2014 Dec;15(12):1366-76. doi: 10.1016/j.jpain.2014.09.013. Epub 2014 Oct 2.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00043.9± 11.37 BG00145.1± 11.06 BG00244.5± 11.20

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00065 BG00179 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG00081 BG00186 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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.

Intent to treat

Posted

Number

percentage of participants

Day 0, Week 12

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00087 OG00193

Title

Denominators

Categories

Responders

Title	Measurements
	OG00016.1 OG00116.1

Non-responders

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	controlled for centers	.8940							95						No	Superiority or Other

Secondary

Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at 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.

Intent to treat. Last observation carried forward. Three participants had no post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

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

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.

Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at 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.

Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at 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.

Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in Daily Sleep Assessment Average Score at 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.

Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at 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.

Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at 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.

Intent to treat population. Last observation carried forward. Thirty-three participants had either no baseline or post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Units

Secondary

Change From Baseline in "Mechanically Evoked" (Allodynia) Numeric Rating Scale (NRS) Score at 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.

Intent to treat population. Last observation carried forward. Sixteen participants had either no baseline or post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at 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.

Intent to treat population. Last observation carried forward. Fifteen participants were missing values.

Posted

Mean

Standard Deviation

units on a scale

Week 12

ID	Title	Description
OG000	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.
OG001	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.

Units

Secondary

Change From Baseline in the Brief Pain Inventory (BPI) Total Score at Week 12

Participants completed the Brief Pain Inventory which asks twelve questions that are rated on an eleven-point scale in which 0=most positive outcome and 10=the most negative outcome for a total scale of 0-120. BPI contains questions that concern the level of pain over the last week and the level of pain right now, the extent to which pain interfered with sleep, normal activities, ability to work, relationships, walking etc. Week 12 values are compared to baseline values. Negative change values indicate improvement.

Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in the Profile of Mood States (POMS) at Week 12

Participants completed the Profile of Mood States questionnaire that asks participants to rate how each of 65 words reflected their mood in the past week on a 5-point scale with 0=not at all and 4=extremely for a total scale of 0-260. Week 12 values are compared to baseline values. Negative change values indicate improvement.

Intent to treat population. Last observation carried forward. Six participants had no post-treatment values.

Posted

Mean

Standard Deviation

units on a scale

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Patient Global Impression of Change (PGIC) at Week 12

The Patient Global Impression of Change asks the question: Overall, how would you rate your CRPS condition since the start of study drug? Answers are represented on a seven-point scale with -3=much worst and +3=much better.

Intent to treat. Forty-five participants had no week 12 values.

Posted

Mean

Standard Deviation

units on a scale

Week 12

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Participants Who Had a Change to CRPS Pain Medication During the Treatment Period

Participants who had any change in CRPS medication during the double-blind treatment period (up to week 12) are summarized. Changes include additions, discontinuations or dosage change of CRPS medication(s).

Intent to treat population

Posted

Number

participants

Day 1 to week 12

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Change From Baseline in the Maximal Composite Motor Nerve Conduction Velocity at Week 12

An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal motor nerve conduct velocity.

Intent to treat population. Fifty participants did not have week 12 values.

Posted

Mean

Standard Deviation

meters/second

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Change From Baseline in the Maximal Composite Sensory Nerve Conduction Velocity at Week 12

Intent to treat population. Fifty participants did not have week 12 values.

Posted

Mean

Standard Deviation

meters/second

Day 0, week 12

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Participants With Treatment-Emergent Adverse Events in the Double-Blind Period or the Extension Period

Counts of study participants who had adverse events (AEs) while treated in either the Double-blind or Extension Periods. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 was used by the investigator to grade the severity of the AEs: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.

AEs are also summarized by whether they were serious, related to treatment and whether the AE caused treatment to be altered.

A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above.

Safety population

Posted

Number

participants

Day 1 up to week 158

ID	Title	Description
OG000	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.
OG001	Placebo to Lenalidomide

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			12	87	77	87
EG001	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.			16	93	72	93

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Joint sprain	Injury, poisoning and procedural complications	MedDRA (5.0)	Systematic Assessment	EG0002 affected87 at risk EG0010 affected93 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0012 affected93 at risk
Thrombosis	Vascular disorders	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk
Blood human chorionic gonadotropin positive	Investigations	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk
Blood potassium decreased	Investigations	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk
Blood pressure diastolic increased	Investigations	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Pregnancy test false positive	Investigations	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk
Neuropathic pain	Nervous system disorders	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0011 affected93 at risk
Tremor	Nervous system disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Bradycardia NOS	Cardiac disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk
Adrenal insufficiency NOS	Endocrine disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Thyroiditis NOS	Endocrine disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Cholecystitis NOS	Hepatobiliary disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Gallbladder obstruction	Hepatobiliary disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Pregnancy NOS	Pregnancy, puerperium and perinatal conditions	MedDRA (5.0)	Systematic Assessment	EG0002 affected87 at risk EG0010 affected93 at risk
Abortion spontaneous NOS	Pregnancy, puerperium and perinatal conditions	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Hemolytic anemia NOS	Blood and lymphatic system disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Vomiting NOS	Gastrointestinal disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Pain NOS	General disorders	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk
Clostridium colitis	Infections and infestations	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Arthritis NOS	Musculoskeletal and connective tissue disorders	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA (5.0)	Systematic Assessment	EG0000 affected87 at risk EG0011 affected93 at risk
Angioneurotic edema	Skin and subcutaneous tissue disorders	MedDRA (5.0)	Systematic Assessment	EG0001 affected87 at risk EG0010 affected93 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Rash NOS	Skin and subcutaneous tissue disorders	MedDRA (5.0)	Systematic Assessment	EG00024 affected87 at risk EG0019 affected93 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (5.0)	Systematic Assessment	EG0008 affected87 at risk EG0014 affected93 at risk
Contusion	Skin and subcutaneous tissue disorders	MedDRA (5.0)	Systematic Assessment	EG0003 affected87 at risk EG0016 affected93 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (5.0)	Systematic Assessment	EG0006 affected87 at risk EG0012 affected93 at risk
Nausea	Gastrointestinal disorders	MedDRA (5.0)	Systematic Assessment	EG00014 affected87 at risk EG00115 affected93 at risk
Diarrhoea NOS	Gastrointestinal disorders	MedDRA (5.0)	Systematic Assessment	EG00011 affected87 at risk EG00110 affected93 at risk
Constipation	Gastrointestinal disorders	MedDRA (5.0)	Systematic Assessment	EG0008 affected87 at risk EG0015 affected93 at risk
Vomiting NOS	Gastrointestinal disorders	MedDRA (5.0)	Systematic Assessment	EG0005 affected87 at risk EG0014 affected93 at risk
Headache	Nervous system disorders	MedDRA (5.0)	Systematic Assessment	EG0009 affected87 at risk EG00113 affected93 at risk
Dizziness	Nervous system disorders	MedDRA (5.0)	Systematic Assessment	EG0009 affected87 at risk EG0016 affected93 at risk
Fatigue	General disorders	MedDRA (5.0)	Systematic Assessment	EG0009 affected87 at risk EG00112 affected93 at risk
Pyrexia	General disorders	MedDRA (5.0)	Systematic Assessment	EG0006 affected87 at risk EG0014 affected93 at risk
Fall	General disorders	MedDRA (5.0)	Systematic Assessment	EG0003 affected87 at risk EG0015 affected93 at risk
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA (5.0)	Systematic Assessment	EG0006 affected87 at risk EG0015 affected93 at risk
Pharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA (5.0)	Systematic Assessment	EG0006 affected87 at risk EG0014 affected93 at risk
Urinary tract infection NOS	Infections and infestations	MedDRA (5.0)	Systematic Assessment	EG0003 affected87 at risk EG0016 affected93 at risk
Sinusitis NOS	Infections and infestations	MedDRA (5.0)	Systematic Assessment	EG0005 affected87 at risk EG0013 affected93 at risk
Alanine aminotransferase increased	Investigations	MedDRA (5.0)	Systematic Assessment	EG0005 affected87 at risk EG0011 affected93 at risk
Muscle cramp	Musculoskeletal and connective tissue disorders	MedDRA (5.0)	Systematic Assessment	EG0005 affected87 at risk EG0014 affected93 at risk
Insomnia	Psychiatric disorders	MedDRA (5.0)	Systematic Assessment	EG0007 affected87 at risk EG0015 affected93 at risk

ID	Term
D012019	Reflex Sympathetic Dystrophy
D010146	Pain
D020918	Complex Regional Pain Syndromes

Ancestor Terms

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000077269	Lenalidomide

Ancestor Terms

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Units	Counts
Participants	OG00085 OG00192

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.