Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01625182

Collaborator

Mitsubishi Tanabe Pharma Corporation (Industry)

106

Enrollment

Locations

Arms

44.4

Actual Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy	Drug: Fingolimod Drug: Placebo Comparator	Phase 3

Detailed Description

This study was a double-blind, randomized, multicenter, placebo-controlled, parallel-group study in patients with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy and treated with IVIg, corticosteroids, or both therapies prior to study entry. Patients meeting the eligibility criteria were randomly assigned in a ratio of 1:1 to receive oral fingolimod (0.5 mg/day) or matching placebo.

The study consisted of 3 periods: a Screening Period, a Double-blind Treatment Period and a Follow-up Period after discontinuation of study drug treatment. Patients who complete the study will have an option to enter an extension.

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Actual Study Start Date :

Dec 22, 2012

Actual Primary Completion Date :

Sep 3, 2016

Actual Study Completion Date :

Sep 3, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fingolimod (FTY720) Participants received Fingolimod 0.5 mg orally once daily.	Drug: Fingolimod Fingolimod 0.5 mg capsules
Placebo Comparator: Placebo Participants received matching placebo to Fingolimod orally once daily.	Drug: Placebo Comparator Matching placebo capsules

Arm

Intervention/Treatment

Experimental: Fingolimod (FTY720)

Participants received Fingolimod 0.5 mg orally once daily.

Drug: Fingolimod

Fingolimod 0.5 mg capsules

Placebo Comparator: Placebo

Participants received matching placebo to Fingolimod orally once daily.

Drug: Placebo Comparator

Matching placebo capsules

Outcome Measures

Primary Outcome Measures

Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale [Month 12]
Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.

Secondary Outcome Measures

Change From Baseline for Grip Strength, Dominant Hand [baseline, Month 6, Month 12]
Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
Change From Baseline for Grip Strength, Non-dominant Hand [baseline, Month 6, Month 12]
Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS) [baseline, Month 6, Month 12]
This questionnaire was constructed using the patients' perception of their ability to perform daily and social activities. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

written informed consent must be obtained before any assessment is performed
The diagnosis of CIDP will use the definition of the EFNS/PNS Task Force First Revision. Patients must either have a clinical diagnosis of CIDP fulfilling the clinical inclusion criteria for typical CIDP or one of the following atypical forms of CIDP: pure motor, or asymmetrical (MADSAM [Lewis-Sumner syndrome]), or IgA or IgG (not IgM) MGUS paraprotein associated.
All patients must also fulfill the clinical exclusion criteria and the definite electrodiagnostic criteria of the EFNS/PNS Task Force First Revision.
disability defined by an INCAT Disability Scale score of 1-9 or, if INCAT score is 0, a documented history of disability sufficient to require treatment within the past 2 years following reduction or interruption of CIDP treatment
receiving IVIg treatment (minimal dose equivalent to 0.4 g/kg every 4 weeks for a minimum of 12 weeks) or corticosteroids (minimal dose equivalent to prednisone 10 mg/day) treatment prior to the screening visit
history of documented clinically meaningful deterioration confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to Screening
stable CIDP symptoms for the 6 weeks before randomization

Exclusion Criteria

other chronic demyelinating neuropathies, including: Distal Acquired Demyelinating Symmetric Neuropathy (DADS) Multifocal Motor Neuropathy (MMN) pure sensory CIDP hematopoietic malignancy except for MGUS
conditions in which the pathogenesis of the neuropathy may be different from CIDP such as: Lyme disease, POEMS syndrome, osteosclerotic myeloma, Castleman's disease
treatment with plasma exchange within 2 months of randomization, immunosuppressive/chemotherapeutic medications: azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate tacrolimus or other immunosuppressive drugs within 6 months of randomization or 5 half-lives (whichever is later), Rituximab in the 2 years prior to randomization (patients that have received rituximab between 1 and 2 years should have B-cell levels within normal range), other cytotoxic immunosuppressive medications with sustained effects (including mitoxantrone, alemtuzumab, cladribine) at any time, hematopoietic stem cell transplantation at any time

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Orange	California	United States	92868
2	Novartis Investigative Site	Miami	Florida	United States	33136
3	Novartis Investigative Site	Saint Petersburg	Florida	United States	33713
4	Novartis Investigative Site	Chicago	Illinois	United States	60637
5	Novartis Investigative Site	Louisville	Kentucky	United States	40202
6	Novartis Investigative Site	Boston	Massachusetts	United States	02115
7	Novartis Investigative Site	New York	New York	United States	10032
8	Novartis Investigative Site	Patchogue	New York	United States	11772
9	Novartis Investigative Site	Plainview	New York	United States	11803
10	Novartis Investigative Site	Columbus	Ohio	United States	43210
11	Novartis Investigative Site	Houston	Texas	United States	77030
12	Novartis Investigative Site	Burlington	Vermont	United States	05401
13	Novartis Investigative Site	Sydney	New South Wales	Australia	2050
14	Novartis Investigative Site	Auchenflower	Queensland	Australia	4066
15	Novartis Investigative Site	Fitzroy	Victoria	Australia	3065
16	Novartis Investigative Site	Parkville	Victoria	Australia	3050
17	Novartis Investigative Site	Bruxelles		Belgium	1200
18	Novartis Investigative Site	Leuven		Belgium	3000
19	Novartis Investigative Site	Liege		Belgium	4000
20	Novartis Investigative Site	Kingston	Ontario	Canada	K7L 2V7
21	Novartis Investigative Site	Québec	Quebec	Canada	G1J 1Z4
22	Novartis Investigative Site	Greenfield Park		Canada	J4V 2J2
23	Novartis Investigative Site	Montreal		Canada	H3A 2B4
24	Novartis Investigative Site	Praha 5		Czechia	150 06
25	Novartis Investigative Site	Limoges		France	87042
26	Novartis Investigative Site	Marseille cedex 05		France	13385
27	Novartis Investigative Site	Montpellier		France	34295
28	Novartis Investigative Site	Paris		France	75013
29	Novartis Investigative Site	Pessac Cedex		France	33604
30	Novartis Investigative Site	Strasbourg		France	67091
31	Novartis Investigative Site	Koeln	Nordrhein-Westfalen	Germany	50937
32	Novartis Investigative Site	Bochum		Germany	44791
33	Novartis Investigative Site	Düsseldorf		Germany	40225
34	Novartis Investigative Site	Essen		Germany	45147
35	Novartis Investigative Site	Göttingen		Germany	37075
36	Novartis Investigative Site	Athens		Greece	GR 151 25
37	Novartis Investigative Site	Thessaloniki		Greece	546 36
38	Novartis Investigative Site	Thessaloniki		Greece	57010
39	Novartis Investigative Site	Haifa		Israel
40	Novartis Investigative Site	Ramat Gan		Israel	52621
41	Novartis Investigative Site	Tel Aviv		Israel	64239
42	Novartis Investigative Site	Legnano	MI	Italy	20025
43	Novartis Investigative Site	Rozzano	MI	Italy	20089
44	Novartis Investigative Site	Cefalù	PA	Italy	90015
45	Novartis Investigative Site	Ferrara		Italy	44100
46	Novartis Investigative Site	Milano		Italy
47	Novartis Investigative Site	Pisa		Italy	56126
48	Novartis Investigative Site	Rome		Italy	00168
49	Novartis Investigative Site	Nagoya	Aichi	Japan	466-8560
50	Novartis Investigative Site	Sayama	Osaka	Japan	589-8511
51	Novartis Investigative Site	Bunkyo	Tokyo	Japan	113-8519
52	Novartis Investigative Site	Kodaira	Tokyo	Japan	187-8551
53	Novartis Investigative Site	Aomori		Japan	030-8553
54	Novartis Investigative Site	Chiba		Japan	260-8677
55	Novartis Investigative Site	Amsterdam		Netherlands	1105 AZ
56	Novartis Investigative Site	Maastricht		Netherlands	5800
57	Novartis Investigative Site	Gdansk		Poland	80-803
58	Novartis Investigative Site	Katowice		Poland	40-662
59	Novartis Investigative Site	Lodz		Poland	93-121
60	Novartis Investigative Site	Barcelona	Cataluña	Spain	08025
61	Novartis Investigative Site	L´Hospitalet de Llobregat	Cataluña	Spain	08907
62	Novartis Investigative Site	Madrid		Spain	28040
63	Novartis Investigative Site	Headington	Oxfordshire	United Kingdom	OX3 9DU
64	Novartis Investigative Site	Glasgow		United Kingdom	G51 4TF
65	Novartis Investigative Site	Liverpool		United Kingdom	L9 7LJ
66	Novartis Investigative Site	London		United Kingdom	WC1N 3BG
67	Novartis Investigative Site	Newcastle Upon Tyne		United Kingdom	NE1 4LP

Sponsors and Collaborators

Novartis Pharmaceuticals
Mitsubishi Tanabe Pharma Corporation

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01625182

Other Study ID Numbers:

CFTY720I2201
2011-005280-24

First Posted:

Jun 21, 2012

Last Update Posted:

Oct 30, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Novartis Pharmaceuticals

chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, FTY720, fingolimod.

Additional relevant MeSH terms:

Polyradiculoneuropathy

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Fingolimod Hydrochloride

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	Participants were assigned randomly to each treatment group in a 1:1 ratio.

Arm/Group Title	Fingolimod (FTY720)	Placebo
Arm/Group Description	Participants received Fingolimod 0.5 mg orally once daily.	Participants received matching placebo to Fingolimod orally once daily.
Period Title: Overall Study
STARTED	54	52
COMPLETED	34	41
NOT COMPLETED	20	11

Baseline Characteristics

Arm/Group Title	Fingolimod (FTY720)	Placebo	Total
Arm/Group Description	Participants received Fingolimod 0.5 mg orally once daily.	Participants received matching placebo to Fingolimod orally once daily.	Total of all reporting groups
Overall Participants	54	52	106
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	54.3 (13.32)	54.6 (11.68)	54.5 (12.48)
Sex: Female, Male (Count of Participants)
Female	17 31.5%	22 42.3%	39 36.8%
Male	37 68.5%	30 57.7%	67 63.2%

Outcome Measures

1. Primary Outcome

Title	Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale
Description	Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
The full analysis set, which included all participants who were assigned randomly to receive treatment, was analyzed.

Arm/Group Title	Fingolimod (FTY720)	Placebo
Arm/Group Description	Participants received Fingolimod 0.5 mg orally once daily.	Participants received matching placebo to Fingolimod orally once daily.
Measure Participants	54	52
Median (95% Confidence Interval) [Days]	721.0	540.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fingolimod (FTY720), Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9838
	Comments
	Method	Regression, Cox
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95% 0.6 to 1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline for Grip Strength, Dominant Hand
Description	Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
Time Frame	baseline, Month 6, Month 12

Outcome Measure Data

Analysis Population Description
Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.

Arm/Group Title	Fingolimod (FTY720)	Placebo
Arm/Group Description	Participants received Fingolimod 0.5 mg orally once daily.	Participants received matching placebo to Fingolimod orally once daily.
Measure Participants	53	50
Month 6	-2.6	-3.8
Month 12	-0.8	-3.9

3. Secondary Outcome

Title	Change From Baseline for Grip Strength, Non-dominant Hand
Description	Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
Time Frame	baseline, Month 6, Month 12

Outcome Measure Data

Analysis Population Description
Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.

Arm/Group Title	Fingolimod (FTY720)	Placebo
Arm/Group Description	Participants received Fingolimod 0.5 mg orally once daily.	Participants received matching placebo to Fingolimod orally once daily.
Measure Participants	53	50
Month 6	-2.7	-6.1
Month 12	-1.2	-5.0

4. Secondary Outcome

Title	Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)
Description	This questionnaire was constructed using the patients' perception of their ability to perform daily and social activities. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration.
Time Frame	baseline, Month 6, Month 12

Outcome Measure Data

Analysis Population Description
Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.

Arm/Group Title	Fingolimod (FTY720)	Placebo
Arm/Group Description	Participants received Fingolimod 0.5 mg orally once daily.	Participants received matching placebo to Fingolimod orally once daily.
Measure Participants	54	51
Month 6	-6.4	-5.5
Month 12	-5.7	-5.1

Adverse Events

	Fingolimod (FTY720)		Placebo		Overall Participants
Time Frame
Adverse Event Reporting Description

Arm/Group Title	Fingolimod (FTY720)		Placebo		Overall Participants
Arm/Group Description	Participants received Fingolimod 0.5 mg orally once daily.		Participants received matching placebo to Fingolimod orally once daily.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fingolimod (FTY720)		Placebo		Overall Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/54 (16.7%)		4/52 (7.7%)		13/106 (12.3%)
General disorders
Oedema peripheral	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Infections and infestations
Abdominal sepsis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Cellulitis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Injury, poisoning and procedural complications
Ankle fracture	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Musculoskeletal and connective tissue disorders
Bursitis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Gastric cancer	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Retroperitoneal cancer	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Nervous system disorders
Cauda equina syndrome	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Chronic inflammatory demyelinating polyradiculoneuropathy	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Guillain-Barre syndrome	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Renal and urinary disorders
Nephrolithiasis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Vascular disorders
Vasculitis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Other (Not Including Serious) Adverse Events
	Fingolimod (FTY720)		Placebo		Overall Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	40/54 (74.1%)		42/52 (80.8%)		82/106 (77.4%)
Blood and lymphatic system disorders
Anaemia	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Leukopenia	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Cardiac disorders
Palpitations	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Tachycardia	0/54 (0%)		2/52 (3.8%)		2/106 (1.9%)
Congenital, familial and genetic disorders
Ventricular septal defect	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Ear and labyrinth disorders
Ear pain	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Tinnitus	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Vertigo	3/54 (5.6%)		3/52 (5.8%)		6/106 (5.7%)
Endocrine disorders
Cushingoid	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Hypothyroidism	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Eye disorders
Blepharitis	2/54 (3.7%)		0/52 (0%)		2/106 (1.9%)
Cataract	1/54 (1.9%)		3/52 (5.8%)		4/106 (3.8%)
Diplopia	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Eye pain	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Eye pruritus	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Iritis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Macular oedema	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Meibomianitis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Metamorphopsia	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Retinal disorder	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Retinoschisis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Subretinal fluid	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Vision blurred	2/54 (3.7%)		0/52 (0%)		2/106 (1.9%)
Visual acuity reduced	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Visual impairment	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Vitreous detachment	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Vitreous floaters	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Gastrointestinal disorders
Abdominal discomfort	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Abdominal distension	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Abdominal mass	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Abdominal pain	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Abdominal pain upper	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Change of bowel habit	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Chronic gastritis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Constipation	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Diarrhoea	3/54 (5.6%)		2/52 (3.8%)		5/106 (4.7%)
Dry mouth	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Dyspepsia	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Dysphagia	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Food poisoning	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Gastrointestinal disorder	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Gastrooesophageal reflux disease	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Gingival cyst	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Gingival hyperplasia	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Nausea	2/54 (3.7%)		6/52 (11.5%)		8/106 (7.5%)
Oesophagitis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Periodontal disease	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Tooth disorder	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Tooth loss	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
General disorders
Adverse drug reaction	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Asthenia	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Chest discomfort	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Discomfort	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Fatigue	4/54 (7.4%)		6/52 (11.5%)		10/106 (9.4%)
Influenza like illness	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Local swelling	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Oedema peripheral	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Pain	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Peripheral swelling	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Pyrexia	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Hepatobiliary disorders
Hepatic function abnormal	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Liver disorder	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Immune system disorders
Drug hypersensitivity	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Infections and infestations
Bronchitis	3/54 (5.6%)		1/52 (1.9%)		4/106 (3.8%)
Candida infection	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Catheter site infection	0/54 (0%)		2/52 (3.8%)		2/106 (1.9%)
Diverticulitis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Ear infection	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Folliculitis	2/54 (3.7%)		3/52 (5.8%)		5/106 (4.7%)
Gastroenteritis	0/54 (0%)		2/52 (3.8%)		2/106 (1.9%)
Gastroenteritis viral	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Herpes zoster	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Influenza	2/54 (3.7%)		0/52 (0%)		2/106 (1.9%)
Laryngitis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Meningitis aseptic	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Nasopharyngitis	6/54 (11.1%)		7/52 (13.5%)		13/106 (12.3%)
Onychomycosis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Oral herpes	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Parasitic gastroenteritis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Periodontitis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Pharyngitis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Pharyngotonsillitis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Sinusitis	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Tinea cruris	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Tinea infection	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Tonsillitis bacterial	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Tooth infection	0/54 (0%)		2/52 (3.8%)		2/106 (1.9%)
Upper respiratory tract infection	1/54 (1.9%)		2/52 (3.8%)		3/106 (2.8%)
Urinary tract infection	3/54 (5.6%)		1/52 (1.9%)		4/106 (3.8%)
Vulvovaginal candidiasis	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Wound infection	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Injury, poisoning and procedural complications
Back injury	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Concussion	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Excoriation	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Fall	4/54 (7.4%)		1/52 (1.9%)		5/106 (4.7%)
Foot fracture	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Hand fracture	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Infusion related reaction	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Joint dislocation	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Joint injury	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Ligament sprain	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Limb injury	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Muscle hernia	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Muscle strain	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Post-traumatic pain	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Procedural headache	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Procedural pain	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Tooth fracture	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Wound	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Wrist fracture	0/54 (0%)		2/52 (3.8%)		2/106 (1.9%)
Investigations
Alanine aminotransferase increased	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Amylase increased	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Aspartate aminotransferase increased	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Blood alkaline phosphatase increased	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Blood cholesterol increased	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Blood urine present	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Carbon monoxide diffusing capacity decreased	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Cardiac murmur	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Gamma-glutamyltransferase increased	3/54 (5.6%)		0/52 (0%)		3/106 (2.8%)
Glycosylated haemoglobin increased	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Grip strength decreased	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Heart rate increased	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Hepatic enzyme increased	2/54 (3.7%)		0/52 (0%)		2/106 (1.9%)
Hepatitis A virus test positive	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Occult blood	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Optic nerve cup/disc ratio increased	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Pulmonary function test decreased	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Serum ferritin decreased	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Metabolism and nutrition disorders
Decreased appetite	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Dyslipidaemia	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Fluid retention	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Hypercholesterolaemia	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Increased appetite	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Vitamin D deficiency	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/54 (1.9%)		2/52 (3.8%)		3/106 (2.8%)
Arthritis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Arthropathy	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Back pain	4/54 (7.4%)		3/52 (5.8%)		7/106 (6.6%)
Bursitis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Exostosis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Joint swelling	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Monarthritis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Muscle spasms	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Muscle twitching	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Muscular weakness	2/54 (3.7%)		2/52 (3.8%)		4/106 (3.8%)
Musculoskeletal pain	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Musculoskeletal stiffness	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Myalgia	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Neck mass	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Neck pain	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Osteoarthritis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Pain in extremity	7/54 (13%)		3/52 (5.8%)		10/106 (9.4%)
Rheumatoid arthritis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Spinal column stenosis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Synovial cyst	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Tendon pain	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Tendonitis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Torticollis	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Fibrous histiocytoma	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Haemangioma	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Haemangioma of skin	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Malignant melanoma in situ	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Melanocytic naevus	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Seborrhoeic keratosis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Skin papilloma	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Uterine leiomyoma	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Nervous system disorders
Amnesia	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Coordination abnormal	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Dizziness	3/54 (5.6%)		2/52 (3.8%)		5/106 (4.7%)
Dysgeusia	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Headache	12/54 (22.2%)		8/52 (15.4%)		20/106 (18.9%)
Hypoaesthesia	2/54 (3.7%)		2/52 (3.8%)		4/106 (3.8%)
Memory impairment	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Meningism	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Migraine	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Neuralgia	0/54 (0%)		2/52 (3.8%)		2/106 (1.9%)
Neuropathy peripheral	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Paraesthesia	5/54 (9.3%)		0/52 (0%)		5/106 (4.7%)
Parkinsonism	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Sciatica	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Somnolence	1/54 (1.9%)		2/52 (3.8%)		3/106 (2.8%)
Syncope	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Tremor	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Psychiatric disorders
Abnormal dreams	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Anxiety	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Hallucination	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Insomnia	1/54 (1.9%)		4/52 (7.7%)		5/106 (4.7%)
Irritability	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Renal and urinary disorders
Cystitis noninfective	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Dysuria	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Urinary tract inflammation	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Reproductive system and breast disorders
Breast cyst	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Breast pain	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Breast swelling	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Dysfunctional uterine bleeding	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Cough	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Dyspnoea	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Dyspnoea exertional	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Epistaxis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Nasal congestion	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Oropharyngeal pain	1/54 (1.9%)		3/52 (5.8%)		4/106 (3.8%)
Rhinitis allergic	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Rhinorrhoea	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Skin and subcutaneous tissue disorders
Actinic keratosis	1/54 (1.9%)		3/52 (5.8%)		4/106 (3.8%)
Alopecia	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Chloasma	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Dermatitis	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Dermatitis allergic	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Dermatitis contact	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Dry skin	1/54 (1.9%)		2/52 (3.8%)		3/106 (2.8%)
Eczema	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Erythema	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Idiopathic urticaria	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Ingrowing nail	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Intertrigo	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Lentigo	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Night sweats	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Onycholysis	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Petechiae	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Pityriasis rosea	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Pruritus	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Rash	2/54 (3.7%)		3/52 (5.8%)		5/106 (4.7%)
Rash erythematous	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Rash generalised	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Rash pruritic	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Rosacea	1/54 (1.9%)		1/52 (1.9%)		2/106 (1.9%)
Seborrhoeic dermatitis	0/54 (0%)		3/52 (5.8%)		3/106 (2.8%)
Skin fissures	1/54 (1.9%)		0/52 (0%)		1/106 (0.9%)
Skin lesion	2/54 (3.7%)		2/52 (3.8%)		4/106 (3.8%)
Urticaria	2/54 (3.7%)		1/52 (1.9%)		3/106 (2.8%)
Vascular disorders
Hot flush	0/54 (0%)		1/52 (1.9%)		1/106 (0.9%)
Hypertension	10/54 (18.5%)		1/52 (1.9%)		11/106 (10.4%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Results Point of Contact

Name/Title	Study Director
Organization	Novartis Pharmaceuticals
Phone	862-778-8300
Email

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01625182

Other Study ID Numbers:

CFTY720I2201
2011-005280-24

First Posted:

Jun 21, 2012

Last Update Posted:

Oct 30, 2017

Last Verified:

Sep 1, 2017

Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Contacts and Locations

Locations

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Investigators

Study Documents (Full-Text)

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Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

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Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

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Results Point of Contact