Phase 2
N=174
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)
Multiple System Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT00977665 ↗Enrolled (actual)
174
Serious AEs
29.9%
Results posted
Feb 2015
Primary outcome: Primary: Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II) — 7.2; 7.8 units on a scale — p=0.6984
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rasagiline mesylate (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II) |
7.2; 7.8 | 0.6984 |
| SECONDARY Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit |
4.9; 4.8 | — |
| SECONDARY Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score |
3.8; 3.0 | — |
| SECONDARY Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation |
46.4; 52.2 | — |
| SECONDARY Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit |
34.1; 42.7 | — |
| SECONDARY Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale |
4.6; 9.3 | — |
| SECONDARY Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48 |
0.1496; 0.1788 | — |
| SECONDARY Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV |
3.8233; 4.3785; 3.6478; 3.5068; 0.7100; 0.6763 | — |
| SECONDARY Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect |
1.875; 1.574 | — |
| SECONDARY Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications |
246; 294 | — |
| SECONDARY Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale |
-1.1572; -0.5786 | — |
| SECONDARY 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) |
35.7; 30.0; 3.6; 6.7; 19.0; 15.6 | — |
| SECONDARY Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II) |
0.4894; 0.7145 | — |
| SECONDARY Total Number of Falls During the Study |
4.00; 5.00 | — |
Summary
To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00977665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.