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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004980-19 | EudraCT Number |
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A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in healthy young versus elderly male and female subjects. Treatment periods will be separated by 13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNV1014802 | Experimental | CNV1014802 150mg three times a day (tid) 7 days plus a single dose on day 8 |
|
| Placebo | Placebo Comparator | Placebo tid 7 days plus a single dose on day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNV1014802 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration | 9 days | |
| Area under the concentration curve | 9 days | |
| Minimum concentration | 9 days | |
| Frequency of adverse events | 9 days | |
| Change in vital signs compared to baseline | 9 days | |
| Change in 12-lead ECG parameters compared to baseline | 9 days | |
| Change in safety lab parameters compared to baseline | 9 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International | London | United Kingdom |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| C000592131 | vixotrigine |
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| Drug |
|
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |