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- ||||||| Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Trial completion: RESUME-1: Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (clinicaltrials.gov) - Mar 22, 2022
P3, N=1004, Completed, Sponsor: Neurana Pharmaceuticals, Inc.
Active, not recruiting --> Completed
- ||| Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Trial completion date: RESUME-1: Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (clinicaltrials.gov) - Jan 24, 2022
P3, N=1004, Active, not recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
Active, not recruiting --> Completed Trial completion date: Jan 2022 --> Apr 2022
- ||||| Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Enrollment closed: RESUME-1: Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (clinicaltrials.gov) - Jan 13, 2022
P3, N=1004, Active, not recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
Trial completion date: Jan 2022 --> Apr 2022 Recruiting --> Active, not recruiting
- ||| Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
P3 data, Journal: RESUME-1: a Phase III study of tolperisone in the treatment of painful, acute muscle spasms of the back. (Pubmed Central) - Dec 2, 2021
P3
Tolperisone is a promising therapeutic for managing acute, painful muscle spasms of the back as it appears to lack the off-target CNS effects often seen with conventional skeletal muscle relaxants. Clinical Trials Registration: NCT04671082.
- || Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Trial completion, Trial completion date: A Phase 1 PK Study of Tolperisone in Healthy Subjects (clinicaltrials.gov) - Sep 5, 2021
P1, N=27, Completed, Sponsor: Neurana Pharmaceuticals, Inc.
Clinical Trials Registration: NCT04671082. Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Sep 2021
- || Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Trial completion: Effects of Tolperisone on Measures of Drowsiness and Cognitive Function (clinicaltrials.gov) - Apr 8, 2021
P1, N=39, Completed, Sponsor: Neurana Pharmaceuticals, Inc.
Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Sep 2021 Active, not recruiting --> Completed
- | Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Trial completion date: A Phase 1 PK Study of Tolperisone in Healthy Subjects (clinicaltrials.gov) - Feb 15, 2021
P1, N=27, Active, not recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
Active, not recruiting --> Completed Trial completion date: Oct 2020 --> Mar 2021
- ||||| Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Enrollment change: RESUME-1: Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (clinicaltrials.gov) - Feb 14, 2021
P3, N=1000, Recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
Trial completion date: Oct 2020 --> Mar 2021 N=750 --> 1000
- |||||||||| Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
New P3 trial: RESUME-1: Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (clinicaltrials.gov) - Dec 16, 2020
P3, N=750, Recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
- || Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Enrollment closed: Effects of Tolperisone on Measures of Drowsiness and Cognitive Function (clinicaltrials.gov) - Sep 21, 2020
P1, N=36, Active, not recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
N=750 --> 1000 Recruiting --> Active, not recruiting
- || Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Enrollment closed: A Phase 1 PK Study of Tolperisone in Healthy Subjects (clinicaltrials.gov) - Sep 8, 2020
P1, N=27, Active, not recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
New P1 trial: A Phase 1 PK Study of Tolperisone in Healthy Subjects (clinicaltrials.gov) - Jul 10, 2020
P1, N=27, Recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
- || Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Enrollment open: Effects of Tolperisone on Measures of Drowsiness and Cognitive Function (clinicaltrials.gov) - Jun 1, 2020
P1, N=36, Recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
New P1 trial: Effects of Tolperisone on Measures of Drowsiness and Cognitive Function (clinicaltrials.gov) - May 28, 2020
P1, N=36, Not yet recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
- | Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Trial completion: STAR: Tolperisone in Acute Muscle Spasm of the Back (clinicaltrials.gov) - Sep 10, 2019
P2, N=415, Completed, Sponsor: Neurana Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||| Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Enrollment closed: STAR: Tolperisone in Acute Muscle Spasm of the Back (clinicaltrials.gov) - Jun 18, 2019
P2, N=415, Active, not recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||| Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Enrollment open: STAR: Tolperisone in Acute Muscle Spasm of the Back (clinicaltrials.gov) - Jan 31, 2019
P2, N=400, Recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||||| Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
New P2 trial: STAR: Tolperisone in Acute Muscle Spasm of the Back (clinicaltrials.gov) - Jan 14, 2019
P2, N=400, Not yet recruiting, Sponsor: Neurana Pharmaceuticals, Inc.
- | Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
Trial completion: Driving Simulation to Assess Non-Sedative Effects of Tolperisone (clinicaltrials.gov) - Sep 4, 2018
P1, N=36, Completed, Sponsor: Neurana Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana
New P1 trial: Driving Simulation to Assess Non-Sedative Effects of Tolperisone (clinicaltrials.gov) - Nov 27, 2017
P1, N=36, Active, not recruiting, Sponsor: Neurana Pharmaceuticals, Inc.