RESTORE: Treatment Interruption of Natalizumab
Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT01071083
Collaborator
Elan Pharmaceuticals (Industry)
175
33
3
20
5.3
0.3
Study Details
Study Description
Brief Summary
This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab.
The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks:
-
when MS symptoms return, and
-
if other drugs for MS may help control MS symptoms during the natalizumab-interruption period.
This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
175 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Treatment Interruption of Natalizumab
Study Start Date
:
Mar 1, 2010
Actual Primary Completion Date
:
Nov 1, 2011
Actual Study Completion Date
:
Nov 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: natalizumab
|
Drug: natalizumab
300 mg intravenous every 4 weeks
|
| Placebo Comparator: IV placebo
|
Other: IV placebo
placebo intravenous every 4 weeks
|
| Active Comparator: interferon β-1a, glatiramer acetate, or methylprednisolone
|
Drug: interferon beta 1-a
30 ug intramuscular once per week
Drug: methylprednisolone
1000 mg intravenous every 4 weeks
Drug: glatiramer acetate
20 mg subcutaneous once daily
|
Outcome Measures
Primary Outcome Measures
- Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria. [28 Weeks]
Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5
Secondary Outcome Measures
- Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria. [28 Weeks]
MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Major criteria include:
-
A diagnosis of a relapsing form of MS
-
Treatment with natalizumab according to locally approved prescribing information
-
Other protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Cullman | Alabama | United States | 35058 |
| 2 | Research Site | San Francisco | California | United States | 94117 |
| 3 | Research Site | Fort Collins | Colorado | United States | |
| 4 | Research Site | Pompano Beach | Florida | United States | 33060 |
| 5 | Research Site | Atlanta | Georgia | United States | 30309 |
| 6 | Research Site | Atlanta | Georgia | United States | 30327 |
| 7 | Research Site | Chicago | Illinois | United States | 60612 |
| 8 | Research Site | Lake Barrington | Illinois | United States | 60010 |
| 9 | Research Site | Des Moines | Iowa | United States | 50314 |
| 10 | Research Site | Boston | Massachusetts | United States | 2135 |
| 11 | Research Site | Boston | Massachusetts | United States | 2215 |
| 12 | Research Site | Buffalo | New York | United States | 14203 |
| 13 | Research Site | Latham | New York | United States | 12110 |
| 14 | Research Site | Patchogue | New York | United States | 11772 |
| 15 | Research Site | Charlotte | North Carolina | United States | 28207 |
| 16 | Research Site | Raleigh | North Carolina | United States | 27607 |
| 17 | Research Site | Cleveland | Ohio | United States | 44195 |
| 18 | Research Site | Uniontown | Ohio | United States | |
| 19 | Research Site | Salt Lake City | Utah | United States | 84103 |
| 20 | Research Site | Seattle | Washington | United States | 98111 |
| 21 | Research Site | Freiburg | Baden-Wuerttemberg | Germany | 79106 |
| 22 | Research Site | Munchen | Bayern | Germany | 81675 |
| 23 | Research Site | Hennigsdorf | Brandenburg | Germany | 16761 |
| 24 | Research Site | Marburg | Hessen | Germany | 35039 |
| 25 | Research Site | Bochum | Nordrhein-Westfalen | Germany | 44791 |
| 26 | Research Site | Dresden | Sachsen | Germany | 1307 |
| 27 | Research Site | Hamburg | Germany | 20246 | |
| 28 | Research Site | L´Hospitalet de Llobregat | Barcelona | Spain | 8907 |
| 29 | Research Site | Málaga | Malaga | Spain | 29010 |
| 30 | Research Site | El Palmar | Murcia | Spain | 30120 |
| 31 | Research Site | Barcelona | Spain | 8035 | |
| 32 | Research Site | Valencia | Spain | 46009 | |
| 33 | Research Site | Valencia | Spain | 46010 |
Sponsors and Collaborators
- Biogen
- Elan Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Biogen
ClinicalTrials.gov Identifier:
NCT01071083
Other Study ID Numbers:
- 101MS205
First Posted:
Feb 19, 2010
Last Update Posted:
Sep 19, 2013
Last Verified:
Nov 1, 2012
Keywords provided by Biogen
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Date of first treatment: 31 March 2010. Date of study completion: 02 November 2011. |
|---|---|
| Pre-assignment Detail | 175 subjects were enrolled, all 175 were randomized. |
| Arm/Group Title | Intravenous Placebo | Natalizumab | Interferon β-1a | Glatiramer Acetate | Methylprednisolone |
|---|---|---|---|---|---|
| Arm/Group Description | placebo matching natalizumab, intravenous every 4 weeks | 300 mg intravenous every 4 weeks | 30 ug intramuscular once per week | 20 mg subcutaneous once daily | 1000 mg intravenous every 4 weeks |
| Period Title: Overall Study | |||||
| STARTED | 42 | 45 | 17 | 17 | 54 |
| COMPLETED | 35 | 43 | 12 | 15 | 46 |
| NOT COMPLETED | 7 | 2 | 5 | 2 | 8 |
Baseline Characteristics
| Arm/Group Title | Natalizumab | Intravenous Placebo | Interferon β-1a | Glatiramer Acetate | Methylprednisolone | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | 300 mg intravenous every 4 weeks | placebo matching natalizumab, intravenous every 4 weeks | 30 ug intramuscular once per week | 20 mg subcutaneous once daily | 1000 mg intravenous every 4 weeks | Total of all reporting groups |
| Overall Participants | 45 | 42 | 17 | 17 | 54 | 175 |
| Age (Years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Years] |
41.2
(9.70)
|
40.0
(10.36)
|
45.1
(9.92)
|
44.1
(7.85)
|
40.1
(9.96)
|
41.2
(9.85)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
37
82.2%
|
31
73.8%
|
14
82.4%
|
14
82.4%
|
39
72.2%
|
135
77.1%
|
| Male |
8
17.8%
|
11
26.2%
|
3
17.6%
|
3
17.6%
|
15
27.8%
|
40
22.9%
|
Outcome Measures
| Title | Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria. |
|---|---|
| Description | Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5 |
| Time Frame | 28 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit. |
| Arm/Group Title | Natalizumab | Intravenous Placebo | Interferon β-1a | Glatiramer Acetate | Methylprednisolone |
|---|---|---|---|---|---|
| Arm/Group Description | 300 mg intravenous every 4 weeks | placebo matching natalizumab, intravenous every 4 weeks | 30 ug intramuscular once per week | 20 mg subcutaneous once daily | 1000 mg intravenous every 4 weeks |
| Measure Participants | 45 | 41 | 14 | 15 | 52 |
| Number [Percentage of subjects meeting criteria] |
4.7
|
60.5
|
28.6
|
53.3
|
54.8
|
| Title | Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria. |
|---|---|
| Description | MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader. |
| Time Frame | 28 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit. |
| Arm/Group Title | Natalizumab | Intravenous Placebo | Interferon β-1a | Glatiramer Acetate | Methylprednisolone |
|---|---|---|---|---|---|
| Arm/Group Description | 300 mg intravenous every 4 weeks | placebo matching natalizumab, intravenous every 4 weeks | 30 ug intramuscular once per week | 20 mg subcutaneous once daily | 1000 mg intravenous every 4 weeks |
| Measure Participants | 45 | 41 | 14 | 15 | 52 |
| Number [Percentage of subjects meeting criteria] |
0.0
|
52.5
|
8.3
|
49.7
|
46.1
|
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Intravenous Placebo | Natalizumab | Interferon β-1a | Glatiramer Acetate | Methylprednisolone | |||||
| Arm/Group Description | placebo matching natalizumab, intravenous every 4 weeks | 300 mg intravenous every 4 weeks | 30 ug intramuscular once per week | 20 mg subcutaneous once daily | 1000 mg intravenous every 4 weeks | |||||
All Cause Mortality |
||||||||||
| Intravenous Placebo | Natalizumab | Interferon β-1a | Glatiramer Acetate | Methylprednisolone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Intravenous Placebo | Natalizumab | Interferon β-1a | Glatiramer Acetate | Methylprednisolone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/ (NaN) | 1/ (NaN) | 1/ (NaN) | 1/ (NaN) | 1/ (NaN) | |||||
| General disorders | ||||||||||
| Chest Pain | 0/42 (0%) | 0 | 1/45 (2.2%) | 1 | 0/17 (0%) | 0 | 0/17 (0%) | 0 | 0/54 (0%) | 0 |
| Infections and infestations | ||||||||||
| Brain Abscess | 0/42 (0%) | 0 | 0/45 (0%) | 0 | 0/17 (0%) | 0 | 0/17 (0%) | 0 | 1/54 (1.9%) | 1 |
| Nervous system disorders | ||||||||||
| Multiple Sclerosis | 1/42 (2.4%) | 1 | 0/45 (0%) | 0 | 0/17 (0%) | 0 | 0/17 (0%) | 0 | 0/54 (0%) | 0 |
| Multiple Sclerosis Relapse | 0/42 (0%) | 0 | 0/45 (0%) | 0 | 0/17 (0%) | 0 | 1/17 (5.9%) | 2 | 0/54 (0%) | 0 |
| Syncope | 0/42 (0%) | 0 | 0/45 (0%) | 0 | 1/17 (5.9%) | 1 | 0/17 (0%) | 0 | 0/54 (0%) | 0 |
| Presyncope | 0/42 (0%) | 0 | 0/45 (0%) | 0 | 1/17 (5.9%) | 2 | 0/17 (0%) | 0 | 0/54 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
| Intravenous Placebo | Natalizumab | Interferon β-1a | Glatiramer Acetate | Methylprednisolone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/ (NaN) | 38/ (NaN) | 15/ (NaN) | 15/ (NaN) | 42/ (NaN) | |||||
| Blood and lymphatic system disorders | ||||||||||
| LYMPHADENOPATHY | 0/42 (0%) | 3/45 (6.7%) | 0/17 (0%) | 0/17 (0%) | 1/54 (1.9%) | |||||
| Gastrointestinal disorders | ||||||||||
| TONGUE CYST | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| CONSTIPATION | 0/42 (0%) | 1/45 (2.2%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| NAUSEA | 0/42 (0%) | 1/45 (2.2%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| General disorders | ||||||||||
| INFLUENZA LIKE ILLNESS | 0/42 (0%) | 0/45 (0%) | 5/17 (29.4%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| GAIT DISTURBANCE | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| INJECTION SITE HAEMATOMA | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| ASTHENIA | 0/42 (0%) | 0/45 (0%) | 2/17 (11.8%) | 0/17 (0%) | 0/54 (0%) | |||||
| INJECTION SITE URTICARIA | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| FATIGUE | 6/42 (14.3%) | 2/45 (4.4%) | 1/17 (5.9%) | 2/17 (11.8%) | 2/54 (3.7%) | |||||
| INJECTION SITE PAIN | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| Immune system disorders | ||||||||||
| DRUG HYPERSENSITIVITY | 0/42 (0%) | 1/45 (2.2%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| Infections and infestations | ||||||||||
| URINARY TRACT INFECTION | 5/42 (11.9%) | 1/45 (2.2%) | 2/17 (11.8%) | 1/17 (5.9%) | 2/54 (3.7%) | |||||
| INFLUENZA | 1/42 (2.4%) | 1/45 (2.2%) | 0/17 (0%) | 0/17 (0%) | 3/54 (5.6%) | |||||
| VULVOVAGINAL CANDIDIASIS | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| UPPER RESPIRATORY TRACT INFECTION | 6/42 (14.3%) | 3/45 (6.7%) | 0/17 (0%) | 3/17 (17.6%) | 6/54 (11.1%) | |||||
| NASOPHARYNGITIS | 5/42 (11.9%) | 11/45 (24.4%) | 4/17 (23.5%) | 1/17 (5.9%) | 5/54 (9.3%) | |||||
| FUNGAL SKIN INFECTION | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| PYELONEPHRITIS | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| INCISION SITE PAIN | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| POST LUMBAR PUNCTURE SYNDROME | 1/42 (2.4%) | 0/45 (0%) | 2/17 (11.8%) | 0/17 (0%) | 2/54 (3.7%) | |||||
| CONCUSSION | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| LACERATION | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 1/54 (1.9%) | |||||
| FALL | 2/42 (4.8%) | 1/45 (2.2%) | 1/17 (5.9%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| CONTUSION | 1/42 (2.4%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| Investigations | ||||||||||
| BLOOD GLUCOSE INCREASED | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| DRUG SPECIFIC ANTIBODY PRESENT | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| PROTEIN URINE PRESENT | 0/42 (0%) | 1/45 (2.2%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| ALANINE AMINOTRANSFERASE INCREASED | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| WHITE BLOOD CELLS URINE POSITIVE | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| LYMPHOCYTE MORPHOLOGY ABNORMAL | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| EOSINOPHIL COUNT INCREASED | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| FOLATE DEFICIENCY | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| IRON DEFICIENCY | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| VITAMIN D DEFICIENCY | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| DEHYDRATION | 0/42 (0%) | 1/45 (2.2%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| BACK PAIN | 1/42 (2.4%) | 2/45 (4.4%) | 0/17 (0%) | 0/17 (0%) | 3/54 (5.6%) | |||||
| MUSCLE SPASMS | 0/42 (0%) | 0/45 (0%) | 2/17 (11.8%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| MUSCULAR WEAKNESS | 4/42 (9.5%) | 2/45 (4.4%) | 0/17 (0%) | 0/17 (0%) | 1/54 (1.9%) | |||||
| PAIN IN EXTREMITY | 1/42 (2.4%) | 3/45 (6.7%) | 0/17 (0%) | 2/17 (11.8%) | 1/54 (1.9%) | |||||
| ARTHRALGIA | 2/42 (4.8%) | 1/45 (2.2%) | 0/17 (0%) | 1/17 (5.9%) | 2/54 (3.7%) | |||||
| JOINT STIFFNESS | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| Nervous system disorders | ||||||||||
| SYNCOPE | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 1/54 (1.9%) | |||||
| MEMORY IMPAIRMENT | 2/42 (4.8%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| HYPOAESTHESIA | 2/42 (4.8%) | 3/45 (6.7%) | 1/17 (5.9%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| HYPERREFLEXIA | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| COGNITIVE DISORDER | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| ANTICHOLINERGIC SYNDROME | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| MULTIPLE SCLEROSIS RELAPSE | 8/42 (19%) | 2/45 (4.4%) | 4/17 (23.5%) | 4/17 (23.5%) | 11/54 (20.4%) | |||||
| NEURALGIA | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| DIZZINESS | 0/42 (0%) | 3/45 (6.7%) | 0/17 (0%) | 0/17 (0%) | 0/54 (0%) | |||||
| MIGRAINE | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| LHERMITTE'S SIGN | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| BURNING FEET SYNDROME | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| HEADACHE | 3/42 (7.1%) | 8/45 (17.8%) | 1/17 (5.9%) | 1/17 (5.9%) | 3/54 (5.6%) | |||||
| PRESYNCOPE | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| DYSGEUSIA | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| PARAESTHESIA | 3/42 (7.1%) | 3/45 (6.7%) | 0/17 (0%) | 0/17 (0%) | 0/54 (0%) | |||||
| BALANCE DISORDER | 1/42 (2.4%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| Psychiatric disorders | ||||||||||
| SLEEP DISORDER | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 3/54 (5.6%) | |||||
| HALLUCINATION, VISUAL | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| PANIC ATTACK | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| ANXIETY | 2/42 (4.8%) | 1/45 (2.2%) | 1/17 (5.9%) | 0/17 (0%) | 1/54 (1.9%) | |||||
| DEPRESSION | 2/42 (4.8%) | 1/45 (2.2%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| BREAST CYST | 0/42 (0%) | 1/45 (2.2%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| DYSPNOEA | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| OROPHARYNGEAL PAIN | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 3/54 (5.6%) | |||||
| INCREASED UPPER AIRWAY SECRETION | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| SINUS CONGESTION | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| PRODUCTIVE COUGH | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| RASH | 0/42 (0%) | 1/45 (2.2%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| ECZEMA | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| SKIN LESION | 0/42 (0%) | 0/45 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/54 (0%) | |||||
| Vascular disorders | ||||||||||
| HYPERTENSION | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
| HYPOTENSION | 0/42 (0%) | 0/45 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/54 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The provisions of our agreement are subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
| Name/Title | Biogen Idec Medical Director |
|---|---|
| Organization | Biogen Idec Inc |
| Phone | 1-617-679-2000 |
| neurologyclinicaltrials@biogenidec.com |
Responsible Party:
Biogen
ClinicalTrials.gov Identifier:
NCT01071083
Other Study ID Numbers:
- 101MS205
First Posted:
Feb 19, 2010
Last Update Posted:
Sep 19, 2013
Last Verified:
Nov 1, 2012