Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)

NCT00977665 | Completed Phase 2 Results DMC

• 2 other identifiers: MSA-RAS-2022009-014644-11
• Study Type: interventional
• Target: 174
• Locations: 12 countries
• Sites: 47

Brief Summary

To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.

Conditions

Multiple System Atrophy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)

  This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement. In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value.

  Day 0 (baseline), Week 48

Secondary Outcomes (13)

• Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit

  Week 48

• Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score

  Day 0 (baseline), Week 24

• Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation

  up to week 48

• Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit

  48 weeks

• Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale

  Day 0 (baseline), Week 48

Study Arms (2)

rasagiline mesylate

EXPERIMENTAL

rasagiline tablet, 1 mg/day for up to 48 weeks.

Drug: rasagiline mesylate

placebo

PLACEBO COMPARATOR

placebo tablet for up to 48 weeks.

Drug: placebo

Interventions

rasagiline mesylate DRUG

rasagiline 1 mg tablet/day for 48 weeks

Also known as: Azilect, TVP-1012

rasagiline mesylate

placebo DRUG

placebo tablet for 48 weeks

placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects over 30 years old with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) according to The Gilman Criteria (2008).
• Subjects who are less than 3 years from the time of documented MSA diagnosis.
• Subjects with an anticipated survival of at least 3 years in the opinion of the investigator.
• Subjects who are willing and able to give informed consent. Subjects who are not able to write may give verbal consent in the presence of at least one witness, and the witness should sign the informed consent form.

You may not qualify if:

• Subjects receiving treatment with midodrine or other sympathomimetics within 4 weeks prior to baseline visit.
• Subjects with severe orthostatic symptoms as assessed by a score of ≥ 3 on Unified Multiple System Atrophy Rating Scale (UMSARS) question 9.
• Subjects who meet any of the following criteria which tend to suggest advanced disease:
• Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
• Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
• Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
• Falling more frequently than once per week as assessed by a score of ≥ 3 on UMSARS question 8
• Subjects taking disallowed medications according to the locally approved Azilect® label.
• Subjects taking monoamine oxidase (MAO) inhibitors within 3 months prior to baseline visit.
• Subjects with hypertension whose blood pressure, in the investigator's opinion, is not well controlled.
• Subjects who, based on the investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Subjects with moderate or severe hepatic impairment.
• Subjects who have taken any investigational products within 60 days prior to baseline.
• Women of child-bearing potential who do not practice an acceptable method of birth control \[acceptable methods of birth control in this study are: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, a double-protection method (condom or diaphragm with spermicide)\].
• Pregnant or nursing women.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• H. Lundbeck A/S: collaborator

Study Sites (47)

Teva Investigational Site 1004

Irvine, California, United States

Location

Teva Investigational Site 1014

La Jolla, California, United States

Location

Teva Investigational Site 1006

Sunnyvale, California, United States

Location

Teva Investigational Site 1010

Washington D.C., District of Columbia, United States

Location

Teva Investigational Site 1061

Boca Raton, Florida, United States

Location

Teva Investigational Site 1012

Tampa, Florida, United States

Location

Teva Investigational Site 1009

Worcester, Massachusetts, United States

Location

Teva Investigational Site 1003

Ann Arbor, Michigan, United States

Location

Teva Investigational Site 1007

Rochester, Minnesota, United States

Location

Teva Investigational Site 1011

St Louis, Missouri, United States

Location

Teva Investigational Site 1008

Rochester, New York, United States

Location

Teva Investigational Site 1001

Cleveland, Ohio, United States

Location

Teva Investigational Site 1002

Philadelphia, Pennsylvania, United States

Location

Teva Investigational Site 1013

Nashville, Tennessee, United States

Location

Teva Investigational Site 1005

Houston, Texas, United States

Location

Teva Investigational Site 3305

Graz, Austria

Location

Teva Investigational Site 3304

Innsbruck, Austria

Location

Teva Investigational Site 1109

Ottawa, Ontario, Canada

Location

Teva Investigational Site 1111

Greenfield Park, Quebec, Canada

Location

Teva Investigational Site 1108

Montreal, Quebec, Canada

Location

Teva Investigational Site 1110

Québec, Quebec, Canada

Location

Teva Investigational Site 3503

Lille, France

Location

Teva Investigational Site 3502

Pessac, France

Location

Teva Investigational Site 3206

Dresden, Germany

Location

Teva Investigational Site 3203

Kiel, Germany

Location

Teva Investigational Site 3201

Marburg, Germany

Location

Teva Investigational Site 3205

München, Germany

Location

Teva Investigational Site 3204

Tübingen, Germany

Location

Teva Investigational Site 3202

Ulm, Germany

Location

Teva Investigational Site 5101

Budapest, Hungary

Location

Teva Investigational Site 5102

Debrecen, Hungary

Location

Teva Investigational Site 5103

Miskolc, Hungary

Location

Teva Investigational Site 8002

Ramat Gan, IL, Israel

Location

Teva Investigational Site 8004

Haifa, Israel

Location

Teva Investigational Site 8003

Tel Aviv, Israel

Location

Teva Investigational Site 3006

Bologna, Italy

Location

Teva Investigational Site 3004

Roma, Italy

Location

Teva Investigational Site 3005

Venezia - Lido, Italy

Location

Teva Investigational Site 3801

Amersfoort, Netherlands

Location

Teva Investigational Site 3802

Sittard-Geleen, Netherlands

Location

Teva Investigational Site 3603

Lisbon, Portugal

Location

Teva Investigational Site 3101

Barcelona, Spain

Location

Teva Investigational Site 3102

Barcelona, Spain

Location

Teva Investigational Site 3103

Seville, Spain

Location

Teva Investigational Site 3403

Cardiff, Wales, United Kingdom

Location

Teva Investigational Site 3401

London, United Kingdom

Location

Teva Investigational Site 3402

Newcastle upon Tyne, United Kingdom

Location

Related Publications (1)

• Poewe W, Seppi K, Fitzer-Attas CJ, Wenning GK, Gilman S, Low PA, Giladi N, Barone P, Sampaio C, Eyal E, Rascol O; Rasagiline-for-MSA investigators. Efficacy of rasagiline in patients with the parkinsonian variant of multiple system atrophy: a randomised, placebo-controlled trial. Lancet Neurol. 2015 Feb;14(2):145-52. doi: 10.1016/S1474-4422(14)70288-1. Epub 2014 Dec 8.

  PMID: 25498732 DERIVED

MeSH Terms

Conditions

Multiple System Atrophy

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Werner Poewe, Prof

  Innsbruck Medical University, Innsbruck, Austria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 26, 2015
• Results First Posted: February 26, 2015

Record last verified: 2015-02

Locations

IT (3); PT (1); IL (3); FR (2); HU (3); US (15); CA (4); DE (6); ES (3); AU (2); NL (2); GB (3)