NCT00977665CompletedPhase 2
A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)
Teva Branded Pharmaceutical Products R&D, Inc.47 sites in 12 countries174 target enrollmentStarted: December 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 174
- Locations
- 47
- Primary Endpoint
- Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)
Study Overview
Brief Summary
To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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.
Arms & Interventions
rasagiline mesylate
Experimental
rasagiline tablet, 1 mg/day for up to 48 weeks.
Intervention: rasagiline mesylate (Drug)
placebo
Placebo Comparator
placebo tablet for up to 48 weeks.
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)
Time Frame: Day 0 (baseline), Week 48
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.
Secondary Outcomes
- Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV(Day 0 (baseline), Week 48 or termination visit)
- Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications(Day 0 (baseline) to Week 48 or termination visit)
- Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale(Day 0 (baseline), Week 48 or termination visit)
- Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)(Day 0 (baseline), Week 48 or termination visit)
- Total Number of Falls During the Study(Day 1 up to week 48)
- 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)
- Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score(Day 0 (baseline), Week 24)
- 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)
- Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit(Week 48)
- Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48(Day 0 (baseline), Weeks 12-48)
- Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #1 (Speech Impairment), Question #2 (Swallowing Impairment) and Question #8 (Falling)(up to week 48)
- Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect(Day 0 (baseline), Week 12)
Investigators
Study Sites (47)
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