NL-OMON51564
Withdrawn
Not Applicable
A Phase 1, Blinded, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of BIIB132 Administered Intrathecally to Adults With Spinocerebellar Ataxia 3 - 260SA101 (Mera)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Biogen
- Enrollment
- 6
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Key Inclusion Criteria:
- •\- Diagnosis of SCA3 with CAG repeats \>\=60 in ATXN3 gene.
- •\- Symptomatic ataxia with a screening Scale for Assessment and Rating of Ataxia
- •(SARA) score 3 to 15 (still ambulatory) and a minimum SARA gait subscore of 1\.
- •\- Able to ambulate 8 m independently without any assistive device.
- •\- Treatment naïve or on a stable dose of symptomatic therapy for a minimum of 4
- •weeks prior to screening.
Exclusion Criteria
- •Key Exclusion Criteria:
- •\- Unstable psychiatric illness or untreated major depression within 90 days
- •before screening.
- •\- History or screening magnetic resonance imaging (MRI) results show evidence
- •of structural abnormalities that could contribute to the participant's clinical
- •state other than findings typical of SCA3 or any finding that might pose a risk
- •to the participant.
- •\- MRI brain findings of prior cerebellar stroke or clinical stroke within 12
- •months before screening.
- •\- History of brain surgery regardless of purpose.
Outcomes
Primary Outcomes
Not specified
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