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Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Lithium Carbonate

Riluzole

placebo

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic lateral sclerosis, ALS, Lou Gehrig's disease, riluzole, lithium, neurodegeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Familial or sporadic ALS
Participants diagnosed with laboratory supported probable, clinically possible, probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria
Disease duration from symptom onset no greater than 36 months at the Screening Visit
Age 18 years or older
Capable of providing informed consent and complying with trial procedures
On a stable dose of riluzole 50 milligrams (mg) twice per day(bid) for at least 30 days prior to screening
Vital capacity (VC) equal to or more than 60% predicted normal value for gender, height and age at the Screening Visit
Creatinine <1.5 milligrams per deciliter (mg/dl) [133 micromoles per liter (umol/L]
Participants maintained on thyroid medication must be euthyroid for at least 3 months before the Screening Visit.
Participants with psoriasis must have inactive disease for at least 30 days before the Screening Visit.
Women must not be able to become pregnant (e.g., post menopausal for at least one year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and be non-lactating.
Geographic accessibility to the study site

Exclusion Criteria:

History of known sensitivity or intolerability to lithium or to any other related compound
Prior exposure to lithium within 90 days of the Screening Visit
Exposure to any investigational agent within 30 days of the Screening Visit
Participants who are malnourished, dehydrated or on a sodium-free diet will be excluded due to the potential side effects of lithium carbonate
Use of digoxin or iodide salts [e.g. calcium iodide, hydrogen iodide (hydriodic acid), iodide, iodinated glycerol (Organidin), iodine, potassium iodide (SSKI), and sodium iodide supplementation beyond table salt]
Presence of any of the following clinical conditions: Substance abuse within the past year; Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease; autoimmune deficiency syndrome (AIDS) or AIDS-related complex; Clinically active psoriasis within 30 days of the Screening Visit; Unstable psychiatric illness defined as psychosis (hallucinations or delusions) or untreated major depression within 90 days of the Screening Visit; Screening serum creatinine greater than or equal to 1.5 mg/dL (133 umol/L), thyroid stimulating hormone (TSH) > 20% above the upper limit; Presence of any clinically significant conduction abnormalities on electrocardiogram (ECG); or Lactating or have a positive serum pregnancy test at the Screening Visit.

Sites / Locations

Phoenix Neurological Assoc., 1331 N. 7th Street, Suite 350
Cedars-Sinai ALS Center, Neurology Specialty Clinic, 8730 Alden Drive, Thalians, E 245
UCSF ALS Center, University of California San Francisco, Neurology, Box 0114, UCSF
Mayo Clinic-Jacksonville, Neurology Department, 4500 San Pablo Road
University of Miami, Miller School of Medicine, 1150 NW 14th Street, Suite 609 (SCs are suite 701)
Indiana University, Department of Neurology, 1050 Wishard Blvd, RG 6
University of Kentucky Medical Center, BAMC, Department of Neurology, Room A307, 1101 Veteran's Drive
Johns Hopkins University, Department of Neurology, 600 N. Wolfe St, Meyer 6-181
Massachusetts General Hospital, 149 13th St, Room 2266
Wayne State University, Department of Neurology, 4201 St. Antoine, 8C UHC
Hennepin County Medical Center, Dept of Neurology, 701 Part Ave S, P5-200
Washington University, 660 S. Euclid Ave., Box 8111 Neurology
Columbia Univ Med Ctr, Eleanor and Lou Gehrig ALS/MDA Center, 710 West 168th St, 9th Floor
SUNY Upstate Medical University, 750 E Adams St, 6610UH
Duke University Medical Center, Box 3333
Wake Forest University, ALS Center, Paul Sticht Center, Ground Floor, Medical Center Blvd
Ohio State University, Neuromuscular Division, 1654 Uphan Drive, 417 Means Hall
Penn State Hershey Medical Center, Department of Neurology, H037, Pennsylvania State Hershey Medical Center
Drexel University College of Medicine, 245 North 15th Street
Texas Neurology, PA, 6301 Gaston Ave, Suite 400 West Tower
University of Vermont, Department of Neurology, 89 Beaumont Drive, Given Bldg, Room C-225
University of Virginia, Department of Neurology, 3100 Hospital Drive
University of Calgary, Area 3, University of Calgary Medical Clinic, 3350 Hospital Drive NW Foothills Hosp. Grounds
University of Alberta, Division of Neurology, Dept of Medicine, 2E3.17 Walter C. MacKenzie Health Sciences Center
University of British Columbia, GF Strong Rehab Centre, 4255 Laurel Street
University of Manitoba
University of New Brunswick, The Stan Cassidy Centre for Rehabilitation, 800 Priestman St.
Dalhousie University, Capital District Health Authority, Queen Elizabeth II Health Sciences Centre, P.O. Box 9000, Summer Street
McMaster University, McMaster University Medical Centre, Hamilton Health Sciences, 1200 Main Street West, Room 4U7, Box 2000
Queen's University, The Adult Neuromuscular Clinic, PCCC, St. Mary's of the Lake Hospital Site, Department of Physical Medicine and Rehabilitation, 340 Union Street, Postal Bldg 3600
University of Western Ontario, Department of Clinical Neurological Sciences, Motor Neuron Disease Clinic, 339 Windermere Road, Box 5339
University of Ottawa, The Rehabilitation Centre, 505 Smyth Road
University of Toronto, Sunnybrook Health Sciences Centre, ALS/Neuromuscular Clinic - SCIL, Room UG-35, 2075 Bayview Ave
University of Montreal, CHUM (Centre Hospitalier de l'Université de Montréal) Notre-Dame Hospital 1560,Sherbrooke east street
McGill University, Montreal Neurological Hospital, 3801 University, Room 205
Laval University, CHA-Enfant-Jesus Hospital, 1401, 18th Street
University of Saskatchewan, Saskatoon City Hospital, 701 Queen Street, Room 7717 - 7th Floor

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Participants randomized to lithium/riluzole (randomization is 1:1 lithium/riluzole to placebo/riluzole, i.e., participants have an equal chance of getting randomized to lithium vs. placebo).

Participants randomized to placebo/riluzole (randomization is 1:1 lithium/riluzole to placebo/riluzole, i.e., participants have an equal chance of getting randomized to lithium vs. placebo).

Outcomes

Primary Outcome Measures

Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R)

ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline.

Secondary Outcome Measures

Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R)

ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Secondary efficacy was evaluated by comparing the mean rate of decline of ALSFRS-R score by treatment group.

Vital Capacity (VC) (Percent of Predicted Normal)

Secondary efficacy was measured by comparing the rate of decline of mean VC by treatment group.

Full Information

NCT ID

NCT00818389

First Posted

January 6, 2009

Last Updated

March 18, 2011

Sponsor

Massachusetts General Hospital

Collaborators

ALS Association, ALS Society of Canada, National Institute of Neurological Disorders and Stroke (NINDS), University of Toronto, State University of New York - Upstate Medical University, Columbia University, University of Kentucky

1. Study Identification

Unique Protocol Identification Number

NCT00818389

Brief Title

Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Official Title

A Multicenter, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Lithium in Combination With Riluzole in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Terminated

Why Stopped

NINDS DSMB recommended trial be terminated for futility after reviewing an interim analysis of 84 subjects.

Study Start Date

January 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Massachusetts General Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare the effectiveness of lithium combined with riluzole to riluzole combined with placebo in people with amyotrophic lateral sclerosis.

Detailed Description

Amyotrophic lateral sclerosis (ALS) is a rare, neurodegenerative disorder that results in progressive wasting and paralysis of voluntary muscles. In this double blind, randomized, placebo-controlled clinical trial, researchers will evaluate the safety and effectiveness of the drug lithium given in combination with riluzole, a drug commonly used to treat ALS, compared to a placebo given in combination with riluzole. Approximately 250 participants will be recruited from multiple centers, in the US and Canada, that belong to the Northeast ALS Consortium (NEALS) and the Canadian ALS Clinical Trials and Research Network (CALS). Enrollment will occur in stages. Initially 84 participants will be enrolled in the trial. An interim analysis using available data will occur after the 84th participant is enrolled. During this time, the Data and Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH) may decide to stop the trial for efficacy or futility reasons or to stop enrollment and request that follow-up continue with the 84 participants already enrolled in the trial, or the DSMB may decide to continue enrollment. Participants will be randomized to one of two arms of the study. Arm one will receive lithium and riluzole. Arm two will receive riluzole and placebo (an inactive substance). All participants will be receiving riluzole. After screening and randomization, participants will be followed every 4 weeks for the first 12 weeks. Subsequent in-person visits will occur every 8 weeks with a final visit at week 52. Between in-person visits, telephone interviews will take place every 4 weeks to administer the Amyotropic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) questionnaire. A follow-up telephone interview will occur at week 56 (off study medication) to review adverse events. The primary outcome measure is disease progression as measured by the ALSFRS-R questionnaire. Participants randomized to placebo whose disease progresses will be crossed over to lithium for the remaining period of the study (up to 52 weeks total). Duration of the study for participants is 56 weeks which includes 52 weeks of treatment and a followup telephone interview at week 56.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis, ALS, Lou Gehrig's disease, riluzole, lithium, neurodegeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Participants randomized to lithium/riluzole (randomization is 1:1 lithium/riluzole to placebo/riluzole, i.e., participants have an equal chance of getting randomized to lithium vs. placebo).

Arm Title

Arm Type

Placebo Comparator

Arm Description

Participants randomized to placebo/riluzole (randomization is 1:1 lithium/riluzole to placebo/riluzole, i.e., participants have an equal chance of getting randomized to lithium vs. placebo).

Intervention Type

Drug

Intervention Name(s)

Lithium Carbonate

Intervention Description

Participants will receive capsules that contain 150 milligrams (mg) lithium carbonate. Participants will be randomized to lithium/riluzole or placebo/riluzole and treated for 52 weeks. Participants originally randomized to placebo who fail (progress) will crossover to lithium for the remainder of the trial.

Intervention Type

Drug

Intervention Name(s)

Riluzole

Intervention Description

All participants enrolled in this study will be taking a stable dose of riluzole 50 milligrams (mg) by mouth (PO) twice per day (BID) for at least 30 days prior to screening.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

an inactive substance

Primary Outcome Measure Information:

Title

Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R)

Description

Time Frame

9 months: Baseline to study termination (January 2009 - October 2009)

Secondary Outcome Measure Information:

Title

Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R)

Description

ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Secondary efficacy was evaluated by comparing the mean rate of decline of ALSFRS-R score by treatment group.

Time Frame

9 months: Baseline to study termination (January 2009 - October 2009)

Title

Vital Capacity (VC) (Percent of Predicted Normal)

Description

Secondary efficacy was measured by comparing the rate of decline of mean VC by treatment group.

Time Frame

9 months: Baseline to study termination (January 2009- October 2009)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Familial or sporadic ALS Participants diagnosed with laboratory supported probable, clinically possible, probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria Disease duration from symptom onset no greater than 36 months at the Screening Visit Age 18 years or older Capable of providing informed consent and complying with trial procedures On a stable dose of riluzole 50 milligrams (mg) twice per day(bid) for at least 30 days prior to screening Vital capacity (VC) equal to or more than 60% predicted normal value for gender, height and age at the Screening Visit Creatinine <1.5 milligrams per deciliter (mg/dl) [133 micromoles per liter (umol/L] Participants maintained on thyroid medication must be euthyroid for at least 3 months before the Screening Visit. Participants with psoriasis must have inactive disease for at least 30 days before the Screening Visit. Women must not be able to become pregnant (e.g., post menopausal for at least one year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and be non-lactating. Geographic accessibility to the study site Exclusion Criteria: History of known sensitivity or intolerability to lithium or to any other related compound Prior exposure to lithium within 90 days of the Screening Visit Exposure to any investigational agent within 30 days of the Screening Visit Participants who are malnourished, dehydrated or on a sodium-free diet will be excluded due to the potential side effects of lithium carbonate Use of digoxin or iodide salts [e.g. calcium iodide, hydrogen iodide (hydriodic acid), iodide, iodinated glycerol (Organidin), iodine, potassium iodide (SSKI), and sodium iodide supplementation beyond table salt] Presence of any of the following clinical conditions: Substance abuse within the past year; Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease; autoimmune deficiency syndrome (AIDS) or AIDS-related complex; Clinically active psoriasis within 30 days of the Screening Visit; Unstable psychiatric illness defined as psychosis (hallucinations or delusions) or untreated major depression within 90 days of the Screening Visit; Screening serum creatinine greater than or equal to 1.5 mg/dL (133 umol/L), thyroid stimulating hormone (TSH) > 20% above the upper limit; Presence of any clinically significant conduction abnormalities on electrocardiogram (ECG); or Lactating or have a positive serum pregnancy test at the Screening Visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Merit Cudkowicz, MD, MSc

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Swati Aggarwal, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lorne Zinman, MD, MSc, FRCPC

Organizational Affiliation

Sunnybrook Health Sciences Center, Univ. of Toronto, Toronto, CA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jinsy Andrews, MD

Organizational Affiliation

Columbia University, New York, NY

Official's Role

Principal Investigator

Facility Information:

Facility Name

Phoenix Neurological Assoc., 1331 N. 7th Street, Suite 350

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Cedars-Sinai ALS Center, Neurology Specialty Clinic, 8730 Alden Drive, Thalians, E 245

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

UCSF ALS Center, University of California San Francisco, Neurology, Box 0114, UCSF

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Mayo Clinic-Jacksonville, Neurology Department, 4500 San Pablo Road

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

University of Miami, Miller School of Medicine, 1150 NW 14th Street, Suite 609 (SCs are suite 701)

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Indiana University, Department of Neurology, 1050 Wishard Blvd, RG 6

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Kentucky Medical Center, BAMC, Department of Neurology, Room A307, 1101 Veteran's Drive

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40502'

Country

United States

Facility Name

Johns Hopkins University, Department of Neurology, 600 N. Wolfe St, Meyer 6-181

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Massachusetts General Hospital, 149 13th St, Room 2266

City

Charlestown

State/Province

Massachusetts

ZIP/Postal Code

02129

Country

United States

Facility Name

Wayne State University, Department of Neurology, 4201 St. Antoine, 8C UHC

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Hennepin County Medical Center, Dept of Neurology, 701 Part Ave S, P5-200

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55415

Country

United States

Facility Name

Washington University, 660 S. Euclid Ave., Box 8111 Neurology

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Columbia Univ Med Ctr, Eleanor and Lou Gehrig ALS/MDA Center, 710 West 168th St, 9th Floor

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

SUNY Upstate Medical University, 750 E Adams St, 6610UH

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Duke University Medical Center, Box 3333

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27707

Country

United States

Facility Name

Wake Forest University, ALS Center, Paul Sticht Center, Ground Floor, Medical Center Blvd

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157-1078

Country

United States

Facility Name

Ohio State University, Neuromuscular Division, 1654 Uphan Drive, 417 Means Hall

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Penn State Hershey Medical Center, Department of Neurology, H037, Pennsylvania State Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Drexel University College of Medicine, 245 North 15th Street

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

Facility Name

Texas Neurology, PA, 6301 Gaston Ave, Suite 400 West Tower

City

Dallas

State/Province

Texas

ZIP/Postal Code

75214

Country

United States

Facility Name

University of Vermont, Department of Neurology, 89 Beaumont Drive, Given Bldg, Room C-225

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05405

Country

United States

Facility Name

University of Virginia, Department of Neurology, 3100 Hospital Drive

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

University of Calgary, Area 3, University of Calgary Medical Clinic, 3350 Hospital Drive NW Foothills Hosp. Grounds

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N1

Country

Canada

Facility Name

University of Alberta, Division of Neurology, Dept of Medicine, 2E3.17 Walter C. MacKenzie Health Sciences Center

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

University of British Columbia, GF Strong Rehab Centre, 4255 Laurel Street

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 2G9

Country

Canada

Facility Name

University of Manitoba

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3T 2N2

Country

Canada

Facility Name

University of New Brunswick, The Stan Cassidy Centre for Rehabilitation, 800 Priestman St.

City

Fredericton

State/Province

New Brunswick

ZIP/Postal Code

E3B 4R3

Country

Canada

Facility Name

Dalhousie University, Capital District Health Authority, Queen Elizabeth II Health Sciences Centre, P.O. Box 9000, Summer Street

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6A5

Country

Canada

Facility Name

McMaster University, McMaster University Medical Centre, Hamilton Health Sciences, 1200 Main Street West, Room 4U7, Box 2000

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Queen's University, The Adult Neuromuscular Clinic, PCCC, St. Mary's of the Lake Hospital Site, Department of Physical Medicine and Rehabilitation, 340 Union Street, Postal Bldg 3600

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5A2

Country

Canada

Facility Name

University of Western Ontario, Department of Clinical Neurological Sciences, Motor Neuron Disease Clinic, 339 Windermere Road, Box 5339

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

University of Ottawa, The Rehabilitation Centre, 505 Smyth Road

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8M2

Country

Canada

Facility Name

University of Toronto, Sunnybrook Health Sciences Centre, ALS/Neuromuscular Clinic - SCIL, Room UG-35, 2075 Bayview Ave

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

University of Montreal, CHUM (Centre Hospitalier de l'Université de Montréal) Notre-Dame Hospital 1560,Sherbrooke east street

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

McGill University, Montreal Neurological Hospital, 3801 University, Room 205

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

Laval University, CHA-Enfant-Jesus Hospital, 1401, 18th Street

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

University of Saskatchewan, Saskatoon City Hospital, 701 Queen Street, Room 7717 - 7th Floor

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0M7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

18250315

Citation

Fornai F, Longone P, Cafaro L, Kastsiuchenka O, Ferrucci M, Manca ML, Lazzeri G, Spalloni A, Bellio N, Lenzi P, Modugno N, Siciliano G, Isidoro C, Murri L, Ruggieri S, Paparelli A. Lithium delays progression of amyotrophic lateral sclerosis. Proc Natl Acad Sci U S A. 2008 Feb 12;105(6):2052-7. doi: 10.1073/pnas.0708022105. Epub 2008 Feb 4. Erratum In: Proc Natl Acad Sci U S A. 2008 Oct 21;105(42):16404-7.

Results Reference

background

PubMed Identifier

20363190

Citation

Aggarwal SP, Zinman L, Simpson E, McKinley J, Jackson KE, Pinto H, Kaufman P, Conwit RA, Schoenfeld D, Shefner J, Cudkowicz M; Northeast and Canadian Amyotrophic Lateral Sclerosis consortia. Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 May;9(5):481-8. doi: 10.1016/S1474-4422(10)70068-5. Epub 2010 Apr 1.

Results Reference

derived

Learn more about this trial

Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

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