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BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose (Beyond)

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ClinicalTrials.gov Identifier: NCT00459667
Recruitment Status : Completed
First Posted : April 12, 2007
Results First Posted : August 17, 2009
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Multiple Sclerosis, Relapsing-Remitting
Intervention Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Enrollment 1420
Recruitment Details Eligible patients for this study included only those who completed the preceding BEYOND study. Patients were enrolled at the conclusion of the preceding study from 03 May 2007 until 14 March 2008. Patients who interrupted study medication in accordance with the investigator were eligible, provided it did not result in premature End of Study.
Pre-assignment Details All enrolled patients who had been randomized during the predecessor study to IFNB 1b (Interferon 1b) continued on previously double-blinded medication in the BEYOND-FU study; all patients who had been previously randomized to Copaxone and all patients with premature end of study medication received open-label IFNB 1b 250 µg (IFNB 1b 250 µg*).
Arm/Group Title IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Hide Arm/Group Description Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind) Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

Period Title: Overall Study
Started 592 647 181
Study Medication Dispensed 586 645 180
Started Treatment 586 644 180
Completed 554 600 161
Not Completed 38 47 20
Reason Not Completed
Adverse Event             9             12             8
Lost to Follow-up             5             9             3
Pregnancy             1             1             1
Protocol Violation             1             0             0
Withdrawal by Subject             3             5             5
Other disease modifying treatment             1             2             1
Other reason (incl. 2 missing subjects)             12             15             1
No treatment administered             6             3             1
Arm/Group Title IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg* Total
Hide Arm/Group Description Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind) Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

Total of all reporting groups
Overall Number of Baseline Participants 586 645 180 1411
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean±Standard Deviation Number Analyzed 586 participants 645 participants 180 participants 1411 participants
36.2  (9.36) 35.8  (9.17) 34.9  (9.5) 35.9  (9.29)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 586 participants 645 participants 180 participants 1411 participants
<=18 years 6 5 2 13
>18 and <55 years 580 640 178 1398
>=55 years 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 586 participants 645 participants 180 participants 1411 participants
Female
414
  70.6%
445
  69.0%
113
  62.8%
972
  68.9%
Male
172
  29.4%
200
  31.0%
67
  37.2%
439
  31.1%
1.Primary Outcome
Title Flu-like-syndrome
Hide Description The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.
Time Frame 309 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Flu-Like-Syndrome with 95% confidence intervals were provided.
Arm/Group Title IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Hide Arm/Group Description:
Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

Overall Number of Participants Analyzed 586 645 180
Measure Type: Number
Unit of Measure: Percentage of participants
17.4 15.8 31.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFNB-1b 500 mcg
Comments The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Number of patients w/ Flu-Like-Syndrome
Estimated Value 17.4
Confidence Interval 95%
14.4 to 20.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IFNB-1b 250 mcg
Comments The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Number of patients w/ Flu-Like-Syndrome
Estimated Value 15.8
Confidence Interval 95%
13.1 to 18.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection IFNB-1b 250 mcg*
Comments The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Number of patients w/ Flu-Like-Syndrome
Estimated Value 31.1
Confidence Interval 95%
24.4 to 38.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Injection-site Reactions
Hide Description The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Time Frame 309 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Injection-site reactions with 95% confidence intervals were provided.
Arm/Group Title IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Hide Arm/Group Description:
Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

Overall Number of Participants Analyzed 586 645 180
Measure Type: Number
Unit of Measure: Percentage of participants
31.7 26.2 31.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFNB-1b 500 mcg
Comments The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter number of patients w/ IS reactions.
Estimated Value 31.7
Confidence Interval 95%
28.0 to 35.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IFNB-1b 250 mcg
Comments The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter number of patients w/ IS reactions.
Estimated Value 26.2
Confidence Interval 95%
22.8 to 29.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection IFNB-1b 250 mcg*
Comments The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter number of patients w/ IS reactions.
Estimated Value 31.7
Confidence Interval 95%
24.9 to 39.0
Estimation Comments [Not Specified]
3.Primary Outcome
Title Liver Enzyme Elevations
Hide Description The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Time Frame 309 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of liver enzyme elevations were provided.
Arm/Group Title IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Hide Arm/Group Description:
Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

Overall Number of Participants Analyzed 586 645 180
Measure Type: Number
Unit of Measure: Percentage of participants
GGT increased 2.7 1.2 3.9
AST increased 2.0 1.4 3.9
ALT increased 2.6 1.7 4.4
4.Primary Outcome
Title Hematological Abnormalities
Hide Description The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Time Frame 309 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of hematological abnormalities were provided.
Arm/Group Title IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Hide Arm/Group Description:
Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

Overall Number of Participants Analyzed 586 645 180
Measure Type: Number
Unit of Measure: Percentage of participants
White blood cells decreased 0.5 1.9 1.7
Neutrophil count decreased 0.5 1.2 2.2
Lymphocyte count decreased 1.5 0.6 0
Platelet count decreased 0.7 0.2 0.6
Hemoglobin decreased 1.2 1.1 0
5.Secondary Outcome
Title Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
Hide Description Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.
Time Frame 309 days
Hide Outcome Measure Data
Hide Analysis Population Description
For the NAb analyses data were provided for 572 patients at Baseline, 238 at Week 26 and 1261 at EOS. The patients missing to the total number of 1411 patients had no data at the respective visits (table shows number of patients with positive titer in the extension treatment cohorts; the analyses provide frequencies of positive titers).
Arm/Group Title IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Hide Arm/Group Description:
Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

Overall Number of Participants Analyzed 527 571 163
Measure Type: Number
Unit of Measure: Percentage of participants
NAbs titer, cut-off value 20 NU/ml 26.6 21.7 16.6
NAbs titer, cut-off value 100 NU/ml 16.5 12.4 2.5
NAbs titer, cut-off value 400 NU/ml 10.8 6.1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Hide Arm/Group Description Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind) Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

All-Cause Mortality
IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/586 (1.88%)   16/645 (2.48%)   6/180 (3.33%) 
Cardiac disorders       
Angina pectoris * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Coronary artery disease * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Congenital, familial and genetic disorders       
Dandy-Walker syndrome * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Gastrointestinal disorders       
Abdominal pain upper * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
General disorders       
Chest pain * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
Papillitis * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
Hepatobiliary disorders       
Bile duct stone * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
Cholecystitis * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Cholecystitis acute * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
Cholelithiasis * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
Jaundice cholestatic * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
Infections and infestations       
Diverticulitis * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Injection site cellulitis * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Injury, poisoning and procedural complications       
Contusion * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Humerus fracture * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Joint sprain * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Ligament injury * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Rib fracture * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Tibia fracture * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Wound * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Investigations       
Arteriogram coronary * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Platelet aggregation * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Musculoskeletal and connective tissue disorders       
Costochondritis * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Intervertebral disc protrusion * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Muscle spasm * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anal cancer * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Breast cancer * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Cervix carcinoma * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Endometrial cancer * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Renal cell carcinoma * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Uterine leiomyoma * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Nervous system disorders       
Carotid artery stenosis * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Multiple Sclerosis * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Optic neuritis * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Sciatica * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Transient ischaemic attack * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Intra-uterine death * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
Psychiatric disorders       
Depression * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Renal and urinary disorders       
Hydronephrosis * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Renal failure actue * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Ureteric obstruction * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Reproductive system and breast disorders       
Metrorrhagia * 1  0/586 (0.00%)  1/645 (0.16%)  0/180 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Pulmonary hypertension * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Surgical and medical procedures       
Bladder catheter replacement * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
Elective surgery * 1  1/586 (0.17%)  0/645 (0.00%)  2/180 (1.11%) 
Rehabilitation therapy * 1  1/586 (0.17%)  0/645 (0.00%)  0/180 (0.00%) 
Vascular disorders       
Hypertensive crisis * 1  0/586 (0.00%)  0/645 (0.00%)  1/180 (0.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
IFNB-1b 500 mcg IFNB-1b 250 mcg IFNB-1b 250 mcg*
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   455/586 (77.65%)   467/645 (72.40%)   136/180 (75.56%) 
Blood and lymphatic system disorders       
Leukopenia * 1  15/586 (2.56%)  17/645 (2.64%)  5/180 (2.78%) 
Neutropenia * 1  14/586 (2.39%)  5/645 (0.78%)  3/180 (1.67%) 
Ear and labyrinth disorders       
Vertigo * 1  11/586 (1.88%)  9/645 (1.40%)  4/180 (2.22%) 
Eye disorders       
Vision blurred * 1  9/586 (1.54%)  12/645 (1.86%)  4/180 (2.22%) 
Gastrointestinal disorders       
Constipation * 1  11/586 (1.88%)  12/645 (1.86%)  7/180 (3.89%) 
Nausea * 1  7/586 (1.19%)  9/645 (1.40%)  6/180 (3.33%) 
General disorders       
Astenia * 1  10/586 (1.71%)  14/645 (2.17%)  0/180 (0.00%) 
Chills * 1  4/586 (0.68%)  7/645 (1.09%)  4/180 (2.22%) 
Fatigue * 1  89/586 (15.19%)  89/645 (13.80%)  23/180 (12.78%) 
Influenza like illness * 1  72/586 (12.29%)  62/645 (9.61%)  37/180 (20.56%) 
Injection site bruising * 1  18/586 (3.07%)  12/645 (1.86%)  3/180 (1.67%) 
Injection site erythema * 1  70/586 (11.95%)  73/645 (11.32%)  17/180 (9.44%) 
Injection site induration * 1  3/586 (0.51%)  2/645 (0.31%)  4/180 (2.22%) 
Injection site mass * 1  4/586 (0.68%)  1/645 (0.16%)  4/180 (2.22%) 
Injection site nodule * 1  0/586 (0.00%)  1/645 (0.16%)  5/180 (2.78%) 
Injection site pain * 1  25/586 (4.27%)  17/645 (2.64%)  11/180 (6.11%) 
Injection site reaction * 1  80/586 (13.65%)  70/645 (10.85%)  20/180 (11.11%) 
Pain * 1  15/586 (2.56%)  6/645 (0.93%)  3/180 (1.67%) 
Pyrexia * 1  6/586 (1.02%)  2/645 (0.31%)  10/180 (5.56%) 
Injection site atrophy * 1  0/586 (0.00%)  1/645 (0.16%)  4/180 (2.22%) 
Oedema peripheral * 1  2/586 (0.34%)  3/645 (0.47%)  4/180 (2.22%) 
Infections and infestations       
Nasopharyngitis * 1  11/586 (1.88%)  21/645 (3.26%)  8/180 (4.44%) 
Sinusitis * 1  5/586 (0.85%)  8/645 (1.24%)  4/180 (2.22%) 
Upper respiratory tract infection * 1  6/586 (1.02%)  12/645 (1.86%)  10/180 (5.56%) 
Urinary tract infection * 1  9/586 (1.54%)  9/645 (1.40%)  8/180 (4.44%) 
Pharyngitis * 1  4/586 (0.68%)  2/645 (0.31%)  4/180 (2.22%) 
Investigations       
Alanine aminotransferase increased * 1  15/586 (2.56%)  11/645 (1.71%)  8/180 (4.44%) 
Aspartate aminotransferase increased * 1  12/586 (2.05%)  9/645 (1.40%)  7/180 (3.89%) 
Gamma-glutamyltransferase increased * 1  16/586 (2.73%)  8/645 (1.24%)  7/180 (3.89%) 
Neutrophil count decreased * 1  3/586 (0.51%)  8/645 (1.24%)  4/180 (2.22%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  25/586 (4.27%)  33/645 (5.12%)  12/180 (6.67%) 
Back pain * 1  35/586 (5.97%)  30/645 (4.65%)  6/180 (3.33%) 
Muscle spams * 1  26/586 (4.44%)  23/645 (3.57%)  6/180 (3.33%) 
Muscular weakness * 1  16/586 (2.73%)  14/645 (2.17%)  3/180 (1.67%) 
Myalgia * 1  13/586 (2.22%)  19/645 (2.95%)  7/180 (3.89%) 
Pain in extremitiy * 1  28/586 (4.78%)  29/645 (4.50%)  14/180 (7.78%) 
Nervous system disorders       
Dizziness * 1  16/586 (2.73%)  13/645 (2.02%)  3/180 (1.67%) 
Headache * 1  72/586 (12.29%)  89/645 (13.80%)  26/180 (14.44%) 
Hypoaesthesia * 1  19/586 (3.24%)  23/645 (3.57%)  7/180 (3.89%) 
Migraine * 1  8/586 (1.37%)  15/645 (2.33%)  2/180 (1.11%) 
Multiple sclerosis relapse * 1  45/586 (7.68%)  71/645 (11.01%)  13/180 (7.22%) 
Muscle spasticity * 1  11/586 (1.88%)  11/645 (1.71%)  7/180 (3.89%) 
Paraesthesia * 1  26/586 (4.44%)  43/645 (6.67%)  12/180 (6.67%) 
Burning sensation * 1  2/586 (0.34%)  8/645 (1.24%)  5/180 (2.78%) 
Psychiatric disorders       
Anxiety * 1  25/586 (4.27%)  27/645 (4.19%)  6/180 (3.33%) 
Depression * 1  56/586 (9.56%)  60/645 (9.30%)  23/180 (12.78%) 
Insomnia * 1  23/586 (3.92%)  35/645 (5.43%)  7/180 (3.89%) 
Renal and urinary disorders       
Micturition urgency * 1  13/586 (2.22%)  6/645 (0.93%)  2/180 (1.11%) 
Urinary incontinence * 1  4/586 (0.68%)  7/645 (1.09%)  4/180 (2.22%) 
Reproductive system and breast disorders       
Menopausal symptoms * 1  3/586 (0.51%)  1/645 (0.16%)  4/180 (2.22%) 
Vascular disorders       
Hypertension * 1  22/586 (3.75%)  26/645 (4.03%)  7/180 (3.89%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Due to the termination of the study before start of Phase B according to protocol defined stopping rules, functional assessments of multiple sclerosis (FAMS) and EuroQoL (EQ-5D) were not performed.
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 sponsor is interested in the publication of the results of every study it performs. As some of the information concerning the study drug and the sponsor's development activities may be strictly confidential, any publication manuscript (including conference contributions, etc.) must first be reviewed by the sponsor before its submission or presentation. Publication of subgroup data and single center data shall not be performed until the complete study has been published.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00459667     History of Changes
Other Study ID Numbers: 91656
2006-005270-47 ( EudraCT Number )
309363 ( Other Identifier: Company internal )
First Submitted: April 11, 2007
First Posted: April 12, 2007
Results First Submitted: March 16, 2009
Results First Posted: August 17, 2009
Last Update Posted: April 23, 2015