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Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT01879241
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm

Tracking Information
First Submitted Date  ICMJE June 12, 2013
First Posted Date  ICMJE June 17, 2013
Last Update Posted Date October 25, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
Survival in ALS-Patients with Rasagiline compared to placebo [ Time Frame: 18 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
  • Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: 18 Months ]
  • Change of individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life [ Time Frame: 18 Months ]
  • Change of slow vital capacity [ Time Frame: 18 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis
Official Title  ICMJE Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - An AMG Trial With a Market Authorized Substance
Brief Summary

The primary objective of the trial is to investigate the survival time (the time from randomization until death or end of the trial) compared between control group and experimental group.

This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with 1 mg/d rasagiline as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 250 enrolled patients. For entry, the El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at least 4 weeks prior to randomization.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • Drug: Rasagiline
  • Drug: Placebo
    a sugar pill manufactured to mimic Rasagiline 1 mg tablet
Study Arms  ICMJE
  • Experimental: Rasagiline

    Rasagiline

    1 mg/day; 18 months

    Intervention: Drug: Rasagiline
  • Placebo Comparator: Placebo
    once daily, 18 months
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
252
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2013)
250
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
  • Disease duration more than 6 months and less than 3 years (inclusive). Disease onset defined as date of first muscle weakness, excluding fasciculations and cramps
  • Vital capacity more than 50% of normal (slow vital capacity; best of three measurements)
  • Age: ≥ 18 years
  • Continuously treated with 100 mg riluzole for at least four weeks
  • Capable of thoroughly understanding all information given and giving full informed consent according to GCP
  • Women of childbearing age must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate i.e. less than 1% per year) when used consistently and correct are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), or double-barrier methods (condom or diaphragm with spermicidal agent or IUD), sexual abstinence or vasectomized partner

Exclusion Criteria:

  • Previous participation in another clinical study within the preceding 12 weeks
  • Tracheostomy or assisted ventilation of any type during the preceding three months
  • Gastrostomy
  • Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
  • Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
  • Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.
  • Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphene.
  • Patients on serotonin reuptake inhibitors (SSRIs). This includes fluoxetine or fluvoxamine.
  • Patients on dextromethorphan, St. John's wort, cyclobenzaprine or other MAO inhibitors (selective or non-selective)
  • Patients taking Antidepressants
  • Confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT greater than 3 times the upper limit of the normal range)
  • Renal insufficiency (serum creatinine more than 2.26 mg/dL)
  • Evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
  • Known hypersensitivity to any component of the study drug
  • Liable to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of emergency
  • Female with childbearing potential, if no adequate contraceptive measures are used
  • Pregnancy or breast-feeding females
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01879241
Other Study ID Numbers  ICMJE RAS-ALS
2011-004482-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Albert Christian Ludolph, Prof., University of Ulm
Study Sponsor  ICMJE University of Ulm
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Albert C. Ludolph, MD, Prof. Department of Neurology, University of Ulm
PRS Account University of Ulm
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP