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Also known as BTRX-246040 oral capsule(s)
BTRX-246040 · 2 trials · 3 indications
UPDRS = Unified Parkinson's Disease Rating Scale. The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a 14-item rating scale, which consists of the motor examination. Each item is scored from 0 (Normal) to 4 (Most severe). The score ranges from 0-56.
The Investigator-administered MADRS includes 10 items assessing the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (absence of symptom) to 6 (severe symptom); the overall score ranges from 0 to 60. MADRS total scores from 0 to 6 indicate normal/symptom absent, from 7 to 19 indicate mild depression, from 20 to 34 indicate moderate depression, and from 35 to 60 indicate severe depression.
| Arm | Type | Description |
|---|---|---|
| BTRX-246040 Cohort 1 | EXPERIMENTAL | BTRX-246040 40 mg administered orally |
| BTRX-246040 Cohort 2 | EXPERIMENTAL | BTRX-246040 80 mg administered orally |
| BTRX-246040 Cohort 3 | EXPERIMENTAL | BTRX-246040 120 mg administered orally |
| Placebo Cohorts 1-3 | PLACEBO_COMPARATOR | Placebo is administered orally at the same number of capsules as active drug in each Cohort. Placebo capsules consist of inactive ingredients and look identical to BTRX-246040. |
| BTRX-246040 | EXPERIMENTAL | 40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks. |
| Placebo | PLACEBO_COMPARATOR | administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks. |
| Name | Type | Description |
|---|---|---|
| BTRX-246040 | DRUG | oral capsule |
| Placebo | DRUG | oral capsule matching BTRX-246040 capsule |
| BTRX-246040 oral capsule(s) | DRUG | BTRX-246040 administered once daily to patients with MDD for 8 weeks |
| Placebo oral capsule(s) | DRUG | administered once daily to patients with MDD for 8 weeks |
Inclusion Criteria: * Diagnosed with Parkinson's disease (PD), consistent with the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD * Men or women ≥ 30 years old and ≤ 76 years old * Female participants must be either surgically sterilized or 2 years post menopausal at screenin...
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BTRX-246040 is an investigational oral small molecule being developed by Neumora Therapeutics, Inc. (ticker NMRA). It is in Phase 2 clinical development for Major Depressive Disorder and Parkinson Disease. The drug is not approved and remains under clinical study.
BTRX-246040 is being studied for the treatment of Major Depressive Disorder and Parkinson Disease. It is an investigational therapy and has not been approved for any indication. Clinical trials have evaluated it in adults with these conditions.
BTRX-246040 is developed by Neumora Therapeutics, Inc., which trades under the ticker symbol NMRA. The company is responsible for the clinical development of the drug.
BTRX-246040 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The Phase 2 trials have been completed.
BTRX-246040 has been evaluated in two completed Phase 2 trials: NCT03608371 in participants with Parkinson Disease with motor fluctuations, and NCT03193398 in patients with Major Depressive Disorder. Both trials were randomized, double-blind, and placebo-controlled.
Yes, BTRX-246040 oral capsule(s) is another name for BTRX-246040. The drug is administered as an oral capsule. It is the same investigational compound developed by Neumora Therapeutics, Inc.