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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 January 2022 |
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Main ID: |
NCT03567057 |
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Date of registration:
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22/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
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Scientific title:
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A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment |
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Date of first enrolment:
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July 18, 2018 |
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Target sample size:
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424 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03567057 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Clinical Trials Chief Medical Officer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Adamas Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed a current IRB-approved informed consent form
- Successful completion of a prior double blind study of ADS-5102 in patients with MS
walking impairment.
Exclusion Criteria:
- Based on the judgment of the investigator or Medical Monitor, participation in the
study would jeopardize the safety of the subject.
- If female, is pregnant or lactating
- If a sexually active female, is not surgically sterile or at least 2 years
post-menopausal, or does not agree to utilize a highly effective hormonal method of
contraception (an IUD, or vasectomized male partner is also acceptable), in
combination with a barrier method, from baseline through at least 4 weeks after the
completion of study treatment. If a sexually active male, does not agree to utilize
condoms from screening through at least 4 weeks after the completion of study
treatment.
- Anticipated treatment with any amantadine formulation other than ADS-5102
- Planned participation in another interventional clinical trial
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Walking Impairment
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Intervention(s)
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Drug: ADS-5102, 274 mg
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Primary Outcome(s)
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Number of Patients With Adverse Events
[Time Frame: Through study completion, an average of 1 year.]
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Secondary Outcome(s)
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Timed 25-Foot Walk (Feet/Second) (Baseline Value)
[Time Frame: Baseline]
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Timed up and go (Baseline Value)
[Time Frame: Baseline]
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2-Minute Walk Test (Baseline Value)
[Time Frame: Baseline]
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Timed 25-Foot Walk (Feet/Second) (Week 52 Value)
[Time Frame: 52 weeks]
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2-Minute Walk Test (Week 24 Value)
[Time Frame: 24 weeks]
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Timed 25-Foot Walk (Feet/Second) (Week 24 Value)
[Time Frame: 24 weeks]
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2-Minute Walk Test (Week 52 Value)
[Time Frame: 52 weeks]
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Timed up and go (Week 24 Value)
[Time Frame: 24 weeks]
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Timed up and go (Week 52 Value)
[Time Frame: 52 weeks]
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Secondary ID(s)
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ADS-AMT-MS303
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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