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)

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00977665
First received: September 15, 2009
Last updated: March 20, 2013
Last verified: March 2013

September 15, 2009
March 20, 2013
November 2009
November 2011   (final data collection date for primary outcome measure)
Change from baseline to Week 48/Termination visit in the total UMSARS score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00977665 on ClinicalTrials.gov Archive Site
  • Change from baseline to week 24 in total UMSARS score. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Ambulation endpoint: whether or not a subject achieves a score of > 3 in UMSARS question 7 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • The score of the COMPASS Select Change scale at Week 48/Termination visit assessed with respect to baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 48/Termination visit in the MSA-QoL scale [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 24 in total UMSARS score. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 48/Termination visit in putaminal fractional anisotropy (FA) values of other brain regions on a ROI-basis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 48/Termination visit in DWI abnormalities [Trace(D) and FA] of other brain regions on a ROI-basis (pons, cerebellum, middle cerebellar peduncle, caudate nucleus, globus pallidum) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in frequency and severity of putaminal atrophy, putaminal hyperintense rim, putaminal signal hypointensity, pontine atrophy, the hot cross bun sign of the pons, atrophy of the cerebellum, atrophy of the MCP and hyperintensity in MCP [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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)

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple System Atrophy
  • Drug: rasagiline mesylate
    randomized 1:1 ratio either rasagiline 1 mg tablet/day or matching placebo for 48 weeks
    Other Name: Azilect
  • Other: placebo
    placebo
    Other Name: placebo
  • Active Comparator: rasagiline mesylate
    rasagiline 1 mg/day
    Intervention: Drug: rasagiline mesylate
  • Placebo Comparator: placebo
    placebo
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
February 2012
November 2011   (final data collection date for primary outcome measure)

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 UMSARS question 9.
  • Subjects who meet any of the following criteria which tend to suggest advanced disease:

    1. Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
    2. Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
    3. Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
    4. 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 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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Portugal,   Spain,   United Kingdom
 
NCT00977665
MSA-RAS-202, EudraCT Number:2009-014644-11
Yes
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
H. Lundbeck A/S
Principal Investigator: Werner Poewe, Prof Innsbruck Medical University, Innsbruck, Austria
Teva Pharmaceutical Industries
March 2013

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